3-hour webinar: Training & Development in the Life Sciences

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Webinar Includes : All the training handouts , certificate ,Q/A and 3 Hrs Live Webinar

  • 19-October-2017 | 00.00 AM

Live Webinar Preventing Medical Device Recalls

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

In a recent study, the FDA has reported a 95% increase in medical device recalls

  • 12-October-2017 | 00.00 AM

2018 Webinar 10 Sure-Fire Tips for Use / Human Factors Engineering to Satisfy the New IEC 62366-1, -2

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Key parts of IEC 62366-1, and its implementation

  • 13-June-2018 | 00.00 AM

Latest guidance from FDA: Process Validation Requirements & Compliance Strategies – 2018 Webinar

By: José Mora ,Principal Consultant.

In this webinar speaker will explain Strategies for achieving a robust and reliable process, Process validation is considered as the first step in process development

  • 21-June-2018 | 00.00 AM

Webinar Medical Devices 101 - Overview of Key Regulatory Requirements - Do’s, Don’ts and Real-World Examples

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

This course is intended to provide an overview of the regulatory requirements for medical devices or what is sometimes referred to as Devices 101.

  • 25-June-2018 | 00.00 AM

Webinar Getting R&D on Board with Risk Analysis

By: Tom Kramer ,President & CEO, Speaker.

ISO 14971 & risk management

  • 29-June-2018 | 00.00 AM

3-hrs Webinar Off Label Promotion for Drugs & Medical Devices

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

How FDA can reconcile

  • 30-November--0001 | 00.00 AM

2018 FDA Guidelines for 510(k) Submission

By: Dr. David Lim Ph.D., RAC, ASQ-CQA ,President and Principal of Regulatory Doctor.

Process leading to timely clearances

  • 11-July-2018 | 00.00 AM

Through the Eyes of an Auditor

By: José Mora ,Principal Consultant.

An external auditor is coming to your plant. Their first impression may have a major impact on your plant's future as well as your

  • 25-July-2018 | 00.00 AM

Live Webinar Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

This webinar highlights some of the potential uses of RWD, and describes the factors that FDA considers when evaluating whether specific RWD is of sufficient

  • 29-August-2018 | 00.00 AM

Is Your Software 510k Ready

By: Nancy Knettell ,Founder and Principal at Software510, LLC.

One of the main reasons that submitting a 510K for Software Enabled Medical Devices or Software as a Medical Device can fail to get

  • 06-September-2018 | 00.00 AM

How to Manage Your Vendors in Clinical Research

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Current FDA regulations and ICH guidelines

  • 12-December-2019 | 00.00 AM

The Importance of Packaging and Labeling in Pharmaceutical Production – Best Practices

By: Michael Esposito ,Principal at TrainReach Consulting, LLC.

Unnecessary increases in cycle time, costly errors, delays in product availability, or product recalls

  • 25-April-2019 | 00.00 AM

HCPCS code billing for medications-find what payers are requiring to pay these codes

By: Stephanie Thomas ,Billing Director, CE Medical Group.

Simplify the process by submitting claims correct the first time

  • 23-July-2019 | 00.00 AM

Successful Supplier Audits

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

A good supplier audit program should allow an organization to assess

  • 18-July-2019 | 00.00 AM

Virtual Seminar on SOP Writing, Training and Compliance for the Pharmaceutical Industry (Module 1: 7th Oct & Module 2 : 24th Oct)

By: Michael Esposito ,Principal at TrainReach Consulting, LLC.

Understand the regulatory implications of what is written in an SOP

  • 07-October-2019 | 00.00 AM

Post-Market Activities in the EU-MDR — A Detailed Analysis(Part 1,21-Nov-19 & Part 2,22-Nov-19

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

What are the key elements of a PMS system?

  • 21-November-2019 | 00.00 AM

Live Webinar FDA Labeling Requirements

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

  • 04-April-2018

Live webinar Supplier Management in a Compliant, Cost-Efficient Manner

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Webinar Includes : All the training handouts , Certificate ,Q/A and 60 mins Live Webinar.

  • 27-March-2017

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Webinar Includes : All the training handouts , Certificate ,Q/A and 90 mins Live Webinar.

  • 22-March-2017

Live Webinar: Best Practices in Preparation for an FDA Computer System Audit

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Webinar Includes : All the training handouts , Certificate ,Q/A and 90 mins Live Webinar.

  • 15-March-2017

Live Webinar Implementing a Risk-Based Internal CGMP Annual Audit Program

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Webinar Includes : All the training handouts , Certificate ,Q/A and 90 mins Live Webinar.

  • 14-March-2017

Live Webinar Proper Execution of Annual Product Reviews

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Webinar Includes : All the training handouts , Certificate ,Q/A and 60 mins Live Webinar.

  • 01-March-2017

Best Practices in Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 26-April-2017

Live Webinar Effective FDA Regulatory Inspections

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 20-April-2017

Live Webinar Achieving Success and Compliance in the Supply Chain

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 18-April-2017

Live Webinar Implementing a Quality by Design program for product development

By: Steven Laurenz ,Principal Consultant, Biophia Consulting Inc.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 06-April-2017

Live Webinar DHF, DMR, DHR, and Technical File / Design Dossier – And the New EU MDR

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Requirements for the U.S. FDA's DHF per the CGMPs, 21 CFR 820.30 and the almost now identical ISO 13485:2016 Design and Development File -- including

  • 17-October-2017

Live Webinar Personnel Training to Assure FDA and ISO Compliance

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 31-May-2017

Live Webinar Use of Electronic Health Records (EHR) in FDA Regulated Clinical Investigations

By: Rachelle D’Souza ,CEO and President, Regulatory Heights Inc.

This webinar will discuss FDA’s current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination products.

  • 22-September-2017

Live Webinar Medical Device MDR following new FDA Guidance

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 25-May-2017

Live Webinar Good Documentation Practices – Real World Application

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

  • 10-January-2018

Live Webinar Implementing a process for the successful Technology Transfer of drug products

By: Steven Laurenz ,Principal Consultant, Biophia Consulting Inc.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 18-May-2017

FDA Guidance: Medical Device Recalls By Ex FDA investigator

By: Larry Spears ,Ex FDA investigator and President at L.Spears Consulting LLC.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 17-May-2017

An Introduction to the New EU Medical Device Regulation

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 16-May-2017

Live Webinar Integration of Enterprise Requirements Planning (ERP) and Legacy Systems in an FDA-Regulated Environment

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 11-May-2017

Live Webinar Continuous Improvement Tools for your Quality Management System

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 10-May-2017

Live Webinar Effective Batch Record Review and Product Release

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 15-February-2018

Live Webinars How to Conduct a Human Factors/ Usability Validation

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 03-May-2017

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 02-May-2017

Live Webinar Medical device cybersecurity following latest FDA Guidance

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 06-June-2017

Live Webinar Risk Management - Principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

Lean Documents and Lean Configuration

  • 07-June-2018

Webinar Risk Based Environmental Monitoring - What Every Regulatory Professional Absolutely Needs to Know

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

How to establish a risk-based Environmental Monitoring Program

  • 29-May-2018

Live Webinar Medical Devices - International Regulatory Compliance & Regulatory Affairs

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 20-June-2017

Live Webinar Investigating Out-of-Specification (OOS) Results

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

This webinar will review the regulatory requirements for investigating an OOS Investigation.

  • 13-March-2018

Live Webinar Document Control for Start-ups: Cost-Efficient and Compliant

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Document control can be a time- and paper-consuming process. To your start-up, time is a valuable commodity. So is money.

  • 28-June-2017

Live Webinar Understanding Aseptic Technique and Cleanroom Behavior

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Aseptic technique, in sterile compounding, contributes in preventing microbiological contamination.

  • 28-June-2018

Live Webinar Management Controls Under FDA QSR and ISO 13485

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

  • 02-October-2017

Live Webinar Current Concepts & Challenges in Cloud Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 09-March-2018

3-hr webinar:Design Controls for Medical Devices

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency.

  • 31-July-2017

Live Webinar FDA Regulation, 3D Printing and Medical Devices

By: Rachelle D’Souza ,CEO and President, Regulatory Heights Inc.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 19-July-2017

Live Webinar Regulatory Submissions all Part of CMC

By: JERRY DALFORS ,Principal, JD Technologies.

  • 26-September-2017

Live webinar Quality Risk Management By Steven Laurenz

By: Steven Laurenz ,Principal Consultant, Biophia Consulting Inc.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 25-July-2017

Live Webinar Using Microsoft Excel to Ensure Accurate Analysis, Monitoring and Training to be within required FDA Compliance – profitability

By: JERRY DALFORS ,Principal, JD Technologies.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 02-August-2017

Live Webinar Project Management for Computer Systems Regulated by FDA

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

This course will describe the best practices for managing such a project, including "who" should be responsible for tasks, "how" the documentation should be accomplished,

  • 29-November-2017

Live Webinar 21 CFR 11 Compliance for Excel Spreadsheets

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional

  • 27-July-2017

Live Webinar Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

By: José Mora ,Principal Consultant.

Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process

  • 24-October-2018

The FDA Inspection: From SOP to 483

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections

  • 10-August-2017

Live Webinar 2017-DMFs in eCTD format

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

You will gain an understanding of contact points with the FDA throughout the lifecycle of the DMF

  • 15-August-2017

Live Webinar Organizational Change Management Best Practices for Computer System Validation in Industries Regulated by FDA

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Organizational change management is a key aspect of computer system activities involving the FDA’s guidelines on the system development life cycle (SDLC).

  • 16-August-2017

3 Hour Webinar: How the FDA is Trained on Medical Device Inspections

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms

  • 26-October-2017

Live Webinar Implementing Effective Regulatory Compliance

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

This webinar will take the participant on a journey that begins with an organizational clean slate and builds all of the key pieces that are

  • 23-August-2017

Live Webinar Design Control Principles for Medical Device Manufacturers

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed

  • 28-August-2017

Regulatory Perspectives on Pharmacogenomics: A Review of Key Issues Faced by FDA

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Submission of pharmacogenomics data as part of a drug or biologic submission, impacts the approval of the submitted product. Complying with FDA requirements on the

  • 30-August-2017

Live Webinar Best Practices for Investigating Deviations and CAPA to avoid 483 observations

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

This webinar will help attendees understand the fundamental investigation steps and skill sets. Key focus will be placed on identification and initial reporting of deviations,

  • 04-April-2018

Live Webinar : Software / Firmware Verification and Validation to Meet Regulatory Requirements

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical,

  • 25-October-2017

Live Webinar Understanding European Filing and Registration Procedures for Drug Approval

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

How to choose the appropriate pathway to drug approval in the EU

  • 06-September-2017

Live Webinar Regulatory Submissions all Part of 510K

By: JERRY DALFORS ,Principal, JD Technologies.

FDA BRIEFING Documents

  • 06-September-2017

Live Webinar Drug Discovery & Development: the FDA Way

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

The Drug Discovery and Development (but also the biologics and medical device) process is a very complex process with every participant focusing on their particular

  • 05-October-2017

Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Cybersecurity is very important for moblile apps. The FDA requirements for cybersecurity in the app design will be explained

  • 19-September-2017

Live Webinar Packaging and Labelling for Commercial and Clinical Products - 2017

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be discussed.

  • 07-September-2017

Live Webinar : Compliant Use of Cloud Technologies in the Life Sciences

By: Joseph Franchetti ,FDA Quality and Regulatory Compliance Specialist.

This presentation will highlight the concerns of industry and give you the confidence you need to maintain a cloud based system in a regulated environment

  • 14-September-2017

Live Webinar Development and Audit of Complaint Handling and MDR Processes

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Application of risk management to complaint handling program

  • 09-October-2017

Live Webinar Review of global strategic drug development opportunities

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

Learn how to plan, control and manage a full global development

  • 12-October-2017

Live Webinar ICH Q11- API Manufacturing

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

Q11 guidance and learn skills for practical implementation of those requirements.

  • 01-November-2017

Live Webinar Pediatric Safety Plan (PSP) in the US

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

Learn how to prepare a PSP

  • 12-October-2017

Live Webinar Post Marketing and Regulatory Complinace

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

The post-marketing obligations encompass more functional areas of the company

  • 06-December-2017

Live Webinar :Device Warning Letters - Review

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

Learn the FDA process for issuance of warning letters

  • 03-October-2017

Live Webinar Quality Assurance During the Clinical Trial

By: Richard Chamberlain ,Owner at Extended Clinical Services, LLC.

This course will give you an introduction to where to do quality assurance and how to do it.

  • 12-October-2017

Live Webinar Achieving Sustainability Results with ISO 26000

By: Kelly Eisenhardt ,Co-Founder and Managing Director of BlueCircle Advisors.

Social responsibility is a high priority for corporate leaders focused on increasing brand awareness along with revenues. It has become a critical success factor for

  • 18-October-2017

Live Webinar Managing Corporate Risks with ISO 31000

By: Kelly Eisenhardt ,Co-Founder and Managing Director of BlueCircle Advisors.

An in depth look into the key components of the ISO 31000 guideline and best practices to implement and support a corporate risk management strategy

  • 17-January-2018

Live Webinar Protecting Your Business with the 5 Critical Conflict Minerals and Anti-Trafficking Regulations

By: Kelly Eisenhardt ,Co-Founder and Managing Director of BlueCircle Advisors.

An in depth look into regulations enacted to manage sourcing of materials from war torn countries and the prevention of supply chain human trafficking and

  • 12-December-2017

Live Webinar Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

By: Kelly Eisenhardt ,Co-Founder and Managing Director of BlueCircle Advisors.

This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and

  • 08-March-2018

Live Webinar Batch Production Record and Device History Record Review and Quality Assessment to ensure compliance with DMF and DMR specifications

By: JERRY DALFORS ,Principal, JD Technologies.

BPRs, DHRs and laboratory control records for critical process steps are to be reviewed and approved by the quality unit(s) before a finished product batch

  • 05-October-2017

Live Webinar Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach

By: JERRY DALFORS ,Principal, JD Technologies.

Different microorganisms in different environments during sterilization have different resistance to the destructive principles that causes the organism or spore to die (lethality) Some extreme

  • 01-November-2017

Live Webinar Process Validation - Statistical Process Control

By: JERRY DALFORS ,Principal, JD Technologies.

To gain a current comprehension of the new PV Guidelines

  • 05-December-2017

Live Webinar : Master Verification and Validation Planning and Implementation

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Verification and validation requirements have always been part of the US FDA’s GMPs

  • 06-December-2017

Live Webinar Validation Concepts for Medical Devices By Susanne Manz

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

Validation is an important element of the Quality System Regulations and ISO13485.

  • 22-November-2017

Live Webinar Design Control, Device Risk Management, and Usability Engineering, Under US CGMPs 21 CFR 820 and ISO 13485

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

The FDA expects companies to perform meaningful, results driven Design Control activities as defined in the CFR, for both new and changed devices. ISO 13485:2016

  • 15-November-2017

Live Webinar Writing Effective Standard Operating Procedures and Work Instructions

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Developing effective regulatory procedures requires an understanding of how documentation should be structured and organized as well as how they should be crafted.

  • 15-December-2017

Live Webinar on Cybersecurity By Angela Bazigos

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

When hackers breach cybersecurity defenses, the risks to enterprises are enormous.

  • 17-November-2017

3 hr Live Webinar Reduce Human Error on the Drug and Device Manufacturing Processes

By: Ginette M. Collazo ,Ph.D, President, Ginette M. Collazo, Inc..

Human Error as the Root Cause

  • 29-November-2017

Live Webinar How to Write Error Free and FDA Compliant Procedures

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

This course offers practical approaches and tools to address human performance issues in GMP related environments

  • 28-February-2018

How to write SOP's that Avoid Human Error

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

SOP writing outline

  • 27-February-2019

Live Webinar How to Select & Manage Vendors in a Regulated Environment (incl. ICH E6)

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Software is widely used in our industry and selection of new software or upgrade of existing software is one of the activities that crop up

  • 23-January-2018

Live webinar Qualification of contract manufacture organizations (cmo)-a risk based approach

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

CMO management principles

  • 25-January-2018

Live Webinar How to Conduct a Human Factors/ Usability Validation

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Human Factors/ Usability Validation

  • 01-February-2018

Live Webinar Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

The FDA requirements for cybersecurity in the app design will be explained

  • 14-February-2018

Live Webinar European Data Protection Regulation – 2018 Implementation

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

European Data Protection Regulation

  • 10-December-2018

Changing your Marketed Device? You Might Need a New 510(k)

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

By FDA Expert 30+ years exp.

  • 14-December-2018

Live Webinar Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

undertake the planned investigation, change control, risk assessment or validation

  • 11-July-2018

Live Webinar How To Comply With 21 CFR 11 Requirements for Electronic Medical Records

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

The FDA has issued guidelines for source documentation contained in electronic medical records (EMR) in the Code of Federal Regulations (CFR) Title 21, Part 11.

  • 12-February-2018

Live Webinar FDA's Two New Guidance Documents on Software and Device Changes and the 510(k)

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Control of medical device changes and a current 510(k) are big issues in recent FDA studies

  • 27-March-2018

Live Webinar Design Control Under 21 CFR 820 (the CGMPs) and ISO 13485

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

This webinar will discuss the 10 required elements of a Design Control System.

  • 09-May-2018

Live webinar Tougher Supplier Controls – Avoid Unwanted Changes

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

The Globalization of the Supply Chain and What That Means

  • 18-April-2018

FDA Compliance and Mobile Applications

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Understanding of computer system validation planning, execution and management concepts

  • 10-December-2018

Live Webinar Analytical Methods Validation for FDA Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Learn How to use Quality by Design (QbD) to enhance Analytical Method Validation

  • 23-April-2018

Live Webinar Network Success

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

To be a successful networker, you must know how to build reciprocal relationships, based in respect, empathy, and mutual benefit.

  • 16-March-2018

Live Webinar Successful FDA Meeting Preparation and Conduct

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

Rehearsal, post-meeting follow-up, and documenting nonformal FDA interactions will also be discussed in detail.

  • 25-April-2018

Live Webinar IEC 60601-1, Ed 3.1 The new paradigm for Medical Device Safety

By: Mike Colvin Ph.D. ,Medical Device Consultant.

Medical electrical equipment-requirements for basic safety and essential performance

  • 22-March-2018

Creating and Maintaining an Effective and Efficient Technical Training Program

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

GMP regulations on the training topic.

  • 02-July-2019

Conducting a life sciences documentation and training gap analysis

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Learn the Elements of a regulatory documentation and training program

  • 12-June-2018

Live Webinar Intro to the new EU Medical Device Regulation

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Current state of the MDDs and MDR

  • 06-April-2018

Live Webinar The prevention of human error in pharmaceutical manufacturing

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Human Error occurs in all settings

  • 03-August-2018

Implementing effective CAPA systems - one 483 avoidance strategy

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

CAPA systems and 483 avoidance strategy

  • 25-July-2018

Live Webinar Regulatory Compliance in the Pharmaceutical Supply Chain

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

FDA's challenge is the restructuring of a company's supply chain

  • 20-March-2018

Live webinar Good Clinical Practices: Regulations and Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Good Clinical Practice (GCP) is a set of broad regulatory requirements

  • 16-April-2018

Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Electronic Records & Electronic Signatures

  • 29-October-2019

5 Hours Webinar : GMP’s in practice: quality systems, common sense compliance, and application

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

12:30 Pm to 1:30 Pm Break

  • 22-March-2018

Webinar ISO 14971 Application of Risk Management to Medical Device : Follow the Process – Avoid the Problems

By: Mike Colvin Ph.D. ,Medical Device Consultant.

This Webinar provides an introduction to risk/benefit analysis concepts for medical devices and IVDs

  • 31-May-2018

2018 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues.

  • 09-May-2018

Live Webinar New and Expected Guidances on Data Standards and Electronic Submissions for Drugs and Medical Products

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

The agencies (FDA, EMEA) encourage electronic submissions and they have developed data standards and other guidelines

  • 24-May-2018

Live Webinar Chipping away at constraints – Practical tips to improve your manufacturing operations

By: José Mora ,Principal Consultant.

Some of us feel that we have to hire a guru in order to apply the Theory of Constraints. Here are some practical things all

  • 25-May-2018

Live Webinar Corrective and Preventive Action (CAPA) - Principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

This webinar presents a new approach yet is based on solid principles and proven practices.

  • 22-May-2018

Live Webinar EO Sterilization Validation / Revalidation per ISO 11135

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

A brief discussion of the lethal rate BI / bioburden approach, and a more detailed discussion of the more commonly used Overkill approach descriptions,

  • 26-June-2018

Live Webinar Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Disaster Recovery and Business Continuity

  • 08-August-2018

FDA's Recent Regulation on the Use of Social Media

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

21 CFR Part 11 (electronic records/ electronic signatures)

  • 24-July-2018

Live Webinar System Development Life Cycle Approach to Computer System Validation and FDA Compliance

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Good Documentation Practices for FDA-Regulated Computer System Validation

  • 27-June-2018

Live Webinar Building effective project teams

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Building the project team

  • 16-July-2018

2018 Guidelines on How to Best Use Regulatory Pathways: ANDA and 505 (b)(2)

By: Dr. David Lim Ph.D., RAC, ASQ-CQA ,President and Principal of Regulatory Doctor.

Understand FDA’s regulatory pathway 505(b)2

  • 21-June-2018

FDA Data Integrity: Do’s, Don’ts and Real-World Case Studies

By: Chinmoy Roy ,BSEE, MSCS US FDA Expert Data integrity & CSV.

Mark your calendar for Tuesday, June 19 for Data Integrity training by the award winning Data Integrity expert 37+ years exp.

  • 19-June-2018

CGMP Inspections / Auditing -- Internal and External

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Past “good” inspections are no indication of future inspection

  • 17-October-2018

Computer System Validation

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Testing, based on risk

  • 11-October-2018

Establishing a Robust Supplier Management Program

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

A robust, yet efficient

  • 26-September-2018

Establishing a Robust Data Integrity Program

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Data over its entire life-cycle

  • 25-February-2019

What to do if you are told by the Agency that your response to the FDA 483 is inadequate

By: Elvia J Cervantes ,Owner at Juarez FDA Auditing & Consulting Services Inc..

Firm should assess the 483 issued

  • 12-October-2018

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

By: Dr. Loren Gelber ,Pharmaceutical consultant.

OTC drug product for marketing

  • 09-October-2018

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

Theory of Lean Documents and also formulates a corresponding Theory

  • 28-September-2018

How to go Paperless in an FDA-Regulated Environment using Electronic Workflow Signature Approvals and Electronic Records

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

FDA requirements for using electronic records and electronic signatures

  • 22-October-2018

Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Live Webinar

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Annual Product Quality Review

  • 19-September-2018

How to Conduct a Human Factors/ Usability Validation Live Webinar

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Human Factors/ Usability study

  • 26-September-2018

Using Quality Principles to Select, Qualify, & Control Contractors to Perform Out-sourcing Operations

By: Howard Cooper, CBA, CQM ,Senior Regulatory Consultant.

Reduces the cost of drug development, manufacturing

  • 25-September-2018

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements Webinar

By: Roger Cowan ,Pharmaceutical Consultant, R Cowan Consulting Services LLC.

Pharmaceutical compressed air system

  • 19-September-2018

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements Webinar

By: Roger Cowan ,Pharmaceutical Consultant, R Cowan Consulting Services LLC.

Microbial retention challenge testing

  • 11-October-2018

Medical Device Recalls: How to Properly, Compliantly, and Promptly Deal with a Recall

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

PR issues for your firm

  • 19-October-2018

Preparing for an FDA Medical Device Sponsor Inspection

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

New product-marketing approvals

  • 01-November-2018

2018 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

How to write, organize, and maintain SOPs and train personnel

  • 27-November-2018

Fundamentals in Utilization Management

By: Toni G. Cesta, Ph.D., RN, FAAN ,Consultant and Owner at Case Management Concepts, LLC.

Strategies for stream-lining the process

  • 01-November-2018

FDA Regulation of Digital Health – Current Status and Recent Developments

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

FDA focusing on Digital Health?

  • 07-December-2018

GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

Preventing fraud should be a standard part of any compliance plan

  • 07-November-2018

eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada

By: Peggy J. Berry, MBA, RAC ,President & CEO at Synergy Consulting.

Assure compliance with CDISC requirements?

  • 24-October-2018

Complaint Handling – Best Practices: What Life Sciences Companies Need to Know Now

By: Peggy J. Berry, MBA, RAC ,President & CEO at Synergy Consulting.

Effective internal systems for receiving

  • 16-December-2019

Building a World-Class Advertising and Promotion Review Program

By: Peggy J. Berry, MBA, RAC ,President & CEO at Synergy Consulting.

Compliance within the US, "gray areas"

  • 11-December-2018

FDA Inspection Readiness

By: Pam Dellea-Giltner ,CEO and principal auditor of PDG Clinical Consulting LLC.

What it means to be “Inspection Ready”

  • 04-December-2018

FDA's Recent Regulation on the Use of Social Media

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Medical devices subject to FDA regulation

  • 19-November-2018

Five things Medical Device Industry should expect in 2019

By: Milind Nadgouda ,Co- founder and Director at RiverArk Limited.

What to expect in 2019

  • 28-November-2018

Efficient and Effective Batch Record Reviews to Improve your Process Capabilities

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Good documentation practices

  • 14-December-2018

Clinical Trial Master File Compliance

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Providing quality assurance for data included in the file

  • 30-January-2019

Data Governance for Computer Systems Regulated by FDA

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Identify the resources, processes and procedures

  • 19-February-2019

Step-by-Step Process for Successful Sterility Failure Investigations

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

When a sterility test failure occurs

  • 22-October-2019

Developing an Effective CAPA Management and Root Cause Analysis System

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Effective CAPA process requires training internal investigators

  • 22-January-2019

Guideline to Aseptic Technique and Clean Room Behavior

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Refresher for those personnel that are familiar with the way to properly work

  • 07-February-2019

Medical Device Cybersecurity and FDA Compliance

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Cybersecurity is a serious concern for medical device safety

  • 13-December-2018

Revising Your Campus Policies to Comply with Title IX, OCR, the Clery Act - Legal and Practical Considerations

By: Dr. Susan Strauss RN Ed.D. ,Workplace & School Harassment & Bullying Consultant, Trainer, Expert Witness, Investigator.

It’s costly to mishandle incidents of sexual harassment and violence

  • 26-February-2019

Burning Up While Burning Out – Compassion Fatigue Awareness & Burnout Prevention for Practitioners

By: Howard Baumgarten ,Founder of Smart Practice Central.

Key signs and symptoms of compassion fatigue

  • 29-November-2018

The role of the Toxicological Pathologist in Preclinical Drug Development according to 21 Cfr. Part 11/58

By: Dr. Elizabeth Neyen ,Chief ToxPath Consulting.

React promptly and efficiently to pathologists

  • 11-December-2018

FDA’s Quality Metrics - Latest Advances

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

For the quality metrics, discusses the draft guidance

  • 23-January-2019

Sharps Safety Program: Risks, Legal Concerns, Prevention & Management of Sharps Injuries

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Occupational transmission of hepatitis B virus

  • 28-January-2019

What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

  • 05-February-2019

Medical Device Software 62304 Compliance

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

IEC 62304 provides a standard for design

  • 26-February-2019

Trends in FDA Compliance and Enforcement for Regulated Computer Systems

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Good Manufacturing, Laboratory and Clinical Practices

  • 07-March-2019

Trends in FDA Compliance for Regulated Computer Systems in the Tobacco Industry

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

FDA’s authority to include the regulation of electronic nicotine delivery systems

  • 04-April-2019

Save Your Food Business!! - Business Continuity & Disaster Recovery

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Ways to minimize impact to the business and to maintain consumer safety

  • 05-March-2019

Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Focus substantive review on submissions that are complete

  • 13-March-2019

Analytical Method Validation and Transfer According to the New FDA Guidance

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Tremendous effort that can be expended in conducting validation studies, efficiency of experimental design

  • 30-November--0001

Controlling Human Error in the Manufacturing Floor

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

Tremendous effort that can be expended in conducting validation studies, efficiency of experimental design

  • 13-June-2019

Supervising a Human Error Free Environment: You can do a Lot More than you Think

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

Human behavior CAN be manipulated reducing the likelihood of these occurrences

  • 08-August-2019

HIPAA Disaster Recovery and Emergency Mode Operations Requirements — Being Prepared to Overcome the Worst

By: Jim Sheldon-Dean ,Principal and Director of Compliance Services, Lewis Creek Systems, LLC.

Not only survive any event, but be able to continue providing the protections and services necessary

  • 25-June-2019

Quality Management and Compliance in the Life Science Industries

By: Erol Ali Cetinok ,Certified Biomedical Auditor (CBA), and trained as a ISO Lead Auditor.

A good Quality Management System (QMS) would add greatly to the success of any organization

  • 30-January-2019

Technical Writing for the Pharmaceutical Manufacturing Industry

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

Writing is more reader centric, as opposed to writer centric

  • 05-February-2019

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

By: Roger Cowan ,Pharmaceutical Consultant, R Cowan Consulting Services LLC.

Cleanroom environment and its testing requirements according to international regulatory standards

  • 29-January-2019

21st Century Cures Act -New Guidance on Medical Device Software Compliance

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Waive the requirement for “informed consent” in specific cases

  • 17-October-2019

Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to meet FDA and International Quality Standards

By: Roger Cowan ,Pharmaceutical Consultant, R Cowan Consulting Services LLC.

Different types of contamination inherent in compressed air

  • 28-February-2019

CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for contract drug manufacture

By: Roger Cowan ,Pharmaceutical Consultant, R Cowan Consulting Services LLC.

How to comply with new FDA and EU guidelines for contract drug manufacturers

  • 21-March-2019

Sterilization of Pharmaceutical Products and Medical Devices

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

How environmental monitoring data is reviewed for product release

  • 21-March-2019

Writing Effective SOPs for the Medical Device and Pharmaceutical Industries

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

How to write clear, concise, and flexible SOPs

  • 07-May-2019

Understanding the FDA Aseptic Processing Guidance Document

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

How final drug product is aseptically processed, pharmaceutical companies can implement

  • 25-July-2019

Complaint Handling Best Practices – Compliance with FDA and ISO Regulations

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

How do you let your customers know that you received their complaint

  • 27-February-2019

How to prepare for and host a FDA inspection and respond to 483’s

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

How to respond to 483s and warning letters

  • 09-July-2019

ASTM 2500: Lessons Learned Through a Decade of Implementation

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

How to implement a validation program based on that approach

  • 18-April-2019

How FDA Trains Its Investigators to Review CAPA, What You Can do to Prepare Complaint Handling in Compliance with FDA and ISO Regulations

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

The document by which FDA inspectors operate during an inspection

  • 12-March-2019

A Bulletproof, Cost-Efficient Supplier Management Program

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

What about supplier quality? Your company must have a procedure in place

  • 09-April-2019

Do's and Don'ts during FDA Inspections

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

How to change and improve your ways of preparing for and getting ready for an FDA inspection

  • 17-May-2019

Compliant Management Controls Under 21 CFR 820 and ISO 13485

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Quality system functions acceptably and is fully sanctioned by and communicated

  • 04-June-2019

Process Validation – Principles and Protocols

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Definitions and application of applicable terminology

  • 16-July-2019

Self Auditing Your Cyber Security Program To Ensure To Mitigate Risks

By: Ms. Michael C. Redmond ,Lead Strategic Consultant, EFPR Group LLP.

Information is critical for the successful management and smooth operation

  • 19-March-2019

How to Establish an Effective IT Governance, Risk and Compliance (GRC) Framework - Organization and Responsibilities

By: Ms. Michael C. Redmond ,Lead Strategic Consultant, EFPR Group LLP.

Help your organization to manage the complexities of an ERM

  • 23-April-2019

Creating a Cyber Incident Response Program That works

By: Ms. Michael C. Redmond ,Lead Strategic Consultant, EFPR Group LLP.

Is your organization prepared if your business is targeted and your Business Operations are impacted? This webinar is designed for managers and project leaders who

  • 23-May-2019

Risk Based Computer System Validation What You Need to Know To Comply with FDA Requirements

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

How to integrate risk based supplier evaluation into the validation process

  • 12-March-2019

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

By: Dr. Afsaneh Motamed Khorasani ,Vice President of Medical Affairs, Easy Global Training.

Expands on general rules and principles of GDP (US & EU)

  • 25-March-2019

New FDA Guidance for Direct-to-Consumer Promotional Labeling and Advertisements

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Detailed overview of the new FDA guidance document in order to educate participates on the agency’s

  • 26-March-2019

Regulatory Requirements for Registration of Medical Device Products in China

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

Learn how to prepare the necessary documents and register your product with the Chinese regulatory authorities

  • 17-October-2019

3 Hrs Design Control Virtual Boot camp: Hazard and Usability Analysis

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

How to comply with the FDA’s requirements for designing and testing a medical device

  • 03-April-2019

Effective Purchasing and Supplier Controls for Medical Device Manufacturers

By: Susanne Manz, MBA, MBB, RAC, CQA ,Quality and Compliance Expert / Auditor for Medical Devices.

Understand your responsibilities in terms of Purchasing Controls

  • 01-May-2019

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

By: Roger Cowan ,Pharmaceutical Consultant, R Cowan Consulting Services LLC.

How environmental monitoring data is reviewed

  • 02-April-2019

Understanding How to Overcome the Challenges of Aseptic Processing and Validation

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

The requirements for aseptic and bulk manufacturing operations

  • 16-April-2019

Pharmaceutical Water Systems

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

Different types of water systems used in the Pharmaceutical Industry

  • 17-April-2019

CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for contract drug manufacture

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

Filter manufacturer vs. the filter user will be thoroughly analyzed

  • 24-April-2019

Strategies to Prevent Manufacture and Distribution of Substandard Medications

By: Michael Esposito ,Principal at TrainReach Consulting, LLC.

Argument that quality is a cost center and does not directly contribute to the company's profits

  • 24-April-2019

FDA's Recent Regulation on the Use of Social Media

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Ways to meet compliance objectives in a cost-beneficial manner

  • 02-May-2019

Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements

By: Roger Cowan ,Pharmaceutical Consultant, R Cowan Consulting Services LLC.

Contract Manufacturing Organizations (CMO) Quality Agreement

  • 09-May-2019

Software Validation for the New FDA Inspections

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Methods to execute necessary testing

  • 14-May-2019

How to Perform a Thorough Root Cause Analysis and CAPA Development

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Systematic approach that utilizes quality tools to objectively identify factors

  • 21-August-2019

Save Your Food Business!! - Business Continuity & Disaster Recovery

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Ways to prevent such impact in the future

  • 26-April-2019

Strategies for Reducing Process Risk Increasing Yield, Reducing COGS and Improving Compliance

By: Ron Snee ,Founder and President of Snee Associates.

What does it mean to reduce risk, to manage risk, and how do you do it?

  • 28-May-2019

FDA’s Regulation for Molecular Diagnostics

By: Todd Graham ,Managing Partner, Delevan Street Biosciences.

How to choose the different tracks of the process

  • 29-May-2019

Qualification of Contract Manufacturer Organizations Based on Practical Experience

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Product quality and safety remains with the company

  • 04-June-2019

Compliant Management Controls Under 21 CFR 820 and ISO 13485

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Steps to confirm whether the requirements are being followed

  • 04-June-2019

FDA’s New Import Program for 2019: Be Prepared and Be Compliant

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

Failure to provide the correct information creates costly delays

  • 13-November-2019

Automating Assays for Clinical Diagnostics

By: Todd Graham ,Managing Partner, Delevan Street Biosciences.

Steps needed to transfer, validate and maintain an automated assay in the laboratory

  • 10-July-2019

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Latest draft guidance from the FDA in regards to Quality Metrics

  • 17-July-2019

SOP's for Bioanalytical Methods Validation

By: Todd Graham ,Managing Partner, Delevan Street Biosciences.

Advantages and challenges in each class

  • 24-July-2019

Effective Change Control Programs

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

The elements regarding successful management an effective Change Control system

  • 13-June-2019

Risk-Based Quality Management Approaches in Clinical Trials

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

Clinical trial sponsors in using risk-based site monitoring

  • 26-June-2019

Root Cause Analysis for CAPA Investigations A Systematic Approach

By: Ron Snee ,Founder and President of Snee Associates.

A systematic approach based on process and systems thinking

  • 06-June-2019

Biopharmaceutical Analytics: Regulations and Validation

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Regulatory requirements governing biopharmaceuticals

  • 10-June-2019

Laboratory Developed Tests: Challenges and Opportunities

By: Todd Graham ,Managing Partner, Delevan Street Biosciences.

What the FDA is asking for with regard to these new regulations

  • 13-June-2019

Using a Learning Management System (LMS) to Develop Pharma Training Curricula

By: Michael Esposito ,Principal at TrainReach Consulting, LLC.

Development of job position curricula in the Pharmaceutical industry

  • 27-June-2019

Validation Essentials for Medical Device Manufacturers – IQ, OQ, PQ

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

Essentials of validation planning, protocol writing, and change management

  • 10-June-2019

Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations

By: John G. Lanese ,President at The Lanese Group, Inc.

Develop an understanding of how a compliant laboratory handles the investigation

  • 24-June-2019

How to Detect Lack of Data Integrity

By: Ron Snee ,Founder and President of Snee Associates.

Data integrity sources and introduces the assessment of “data pedigree”

  • 10-July-2019

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

By: Michael Esposito ,Principal at TrainReach Consulting, LLC.

Problem of counterfeit drugs and suggest ways to combat it

  • 03-July-2019

Bad Standard Operating Procedures (SOPs) = Bad Training: Garbage In, Garbage Out

By: Michael Esposito ,Principal at TrainReach Consulting, LLC.

How to maximize this connection to improve the quality of both SOPs

  • 11-July-2019

Monitoring Product Quality, Process Performance and Enabling Continued Process Verification – A Systems Approach

By: Ron Snee ,Founder and President of Snee Associates.

Disciplined and structured QbD approach to achieve this objective

  • 17-July-2019

Non-conforming Material and Failure Investigation

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

Confusing regulations and effectively deal with non-conforming material

  • 22-July-2019

Process Validation General Principles & Practices – Integrating the FDA and EU Guidance; ICH Q8, ICH Q9, ICH Q10 and Quality Metrics

By: John G. Lanese ,President at The Lanese Group, Inc.

ICH guidance documents, US inspectional guidance and how they relate

  • 23-September-2019

Understanding the FDA Compounding Pharmacies Guidance Document

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

Why the Compounding Pharmacy Guidance document is being implemented

  • 09-July-2019

10 Sure-Fire Tips for Implementation and Management of GMP Data Integrity Any Investigator Would Love

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Understanding of the regulatory expectations for Data Integrity

  • 03-December-2019

Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

General procedure for the preparation and documentation of the Annual Product Quality Review

  • 06-August-2019

Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

How in sterile compounding, aseptic technique is contributing to the prevention

  • 25-September-2019

Handling OOS Test Results and Completing Robust Investigations

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Detection an out-of-specification result to informal and formal laboratory and batch investigations

  • 07-November-2019

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

Import and export process for unapproved and approved medical devices

  • 27-August-2019

Quality is not an Organization

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

What does Quality mean to you?

  • 29-August-2019

Learn How Blockchain Will Become the Basis for an Integrated Food Safety System (IFFS)

By: Dr. John M. Ryan ,Quality assurance administrator.

How risk levels and probable supply chain failure points can be calculated

  • 18-July-2019

Artificial Intelligence (AI) in the Food Supply Chain

By: Dr. John M. Ryan ,Quality assurance administrator.

Current trends and products coming your way regardless of where you sit in the food supply chain

  • 18-September-2019

How to write SOP's that Avoid Human Error

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

Development to formats designed for human error reduction

  • 03-December-2019

Secrets for Writing Excellent SOPs (Standard Operating Procedures)

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

Structure your QMS and develop accurate

  • 03-September-2019

The Influence of recent FDA and USP activities on Test Method Validation

By: John G. Lanese ,President at The Lanese Group, Inc.

Lifecycle approach to test method validation

  • 03-September-2019

3-Hour Virtual Seminar on Human Error Reduction in the Manufacturing Floor

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

Practical approaches and models to address human performance issues in GMP

  • 24-September-2019

Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

What is a combination product? What are some examples of combination products?

  • 26-September-2019

Moving from GMPs to the Pharmaceutical Quality System

By: John G. Lanese ,President at The Lanese Group, Inc.

Firm must implement to be compliant with the CGMPs

  • 03-October-2019

ISO/IEC 17025:2017 Section 8 – Management System Requirements

By: Michael Brodsky ,Lead Auditor, Canadian Association for Laboratory Accreditatio.

Changes in the standard and what you must do to update your QMS

  • 05-August-2019

SOP's for Bioanalytical Methods Validation

By: Todd Graham ,Managing Partner, Delevan Street Biosciences.

Validation goes off without a hitch

  • 07-August-2019

Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

How to determine whether your app is a medical device

  • 19-September-2019

Understanding Cleanroom Microbiology – Building A Foundation For Compliance

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Contamination control and clean room management

  • 11-October-2019

GxP/GMP and its Consequences for Documentation and IT Systems

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Documentation is a critical tool for ensuring GxP/GMP compliance

  • 26-September-2019

Best Practices for Preparing for an FDA Computer System Validation Audit

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Current trends in compliance and enforcement that can help in preparation for an FDA inspection or audit

  • 16-September-2019

APPLYING COMPUTER SYSTEM VALIDATION TO MOBILE APPLICATIONS

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Computer system validation can be applied to mobile applications

  • 12-November-2019

Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Best practices and strategic approach for evaluating computer systems

  • 15-October-2019

3-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Current trends in cybersecurity threats to medical devices

  • 04-December-2019

Environmental Monitoring Investigations

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

Comprehensive report the inspector is looking

  • 08-October-2019

3 hrs Virtual Seminar Internal Auditor Training

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Acquire the knowledge and skills to conduct GMP Internal Audits

  • 17-September-2019

Aseptic Processing Overview and Validation

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Requirements for aseptic and bulk manufacturing operations

  • 15-October-2019

Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

By: Joy McElroy ,Principle Consultant, Maynard Consulting Company.

Implemented what they have stated in written procedures

  • 23-September-2019

FDA Compliant QC and QA Practices: Creating a Perfect, Audit-Ready QMS

By: Joy McElroy ,Principle Consultant, Maynard Consulting Company.

General public assumes manufactured pharmaceutical products are safe

  • 12-November-2019

FDA Regulations for Analytical Instrument Qualification and Validation Processes

By: Joy McElroy ,Principle Consultant, Maynard Consulting Company.

Global agencies expectations of analytical equipment qualification along with the development

  • 05-December-2019

Analytical Method Validation

By: John G. Lanese ,President at The Lanese Group, Inc.

Best practices of analytical method validation

  • 12-November-2019

Assess Your Laboratory - Based on the FDA System Based Inspection

By: John G. Lanese ,President at The Lanese Group, Inc.

Quality Control Laboratory plays an important part role

  • 05-December-2019

Auditing for Microbiological Aspects of Pharmaceutical Manufacturing

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

Understand, how, where, when, and why the microbes are in your process

  • 30-September-2019

Your Social Media Marketing is Under FDA's Microscope

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

The use of social media is ripe for regulatory blunders if your not paying attention.

  • 22-November-2019

Statistical Process Control – Keys to Assess Process Variation and Ensure Quality

By: William Levinson ,Principal Consultant at Levinson Productivity.

Understand the basics of SPC, as well as the effect of variation on quality and the difference

  • 23-October-2019

60 Minutes Live Webinar Data Security

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

How to implement data security, e-discovery and crisis preparedness

  • 10-October-2019

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

Latest trends in human error issues in the industry

  • 17-October-2019

Medical device cybersecurity following latest FDA Guidance in 2019

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

A program that will be compliant to the FDA requirements

  • 06-November-2019

Corrective and Preventive Action; Your Most Important Process

By: William Levinson ,Principal Consultant at Levinson Productivity.

CAPA is arguably the most important process in a quality management system

  • 20-November-2019

The Value of Human Factors

By: Thomas Bento ,Sr. Regulatory Consultant.

The ISO 62366 is noted by FDA as a “Consensus” Standard, making it a gold standard

  • 22-October-2019

Navigating the 510(k) process

By: Thomas Bento ,Sr. Regulatory Consultant.

Simplified defensible approach to a successful submission

  • 12-November-2019

The Validation of Non Product Software

By: Thomas Bento ,Sr. Regulatory Consultant.

How to comply with 21 CFR Part 820.70(i) and effectively implement a software validation

  • 05-December-2019

Good Documentation Practice (GDocP) for FDA Regulated Industries

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Connection between GxP/GMP and document control

  • 23-January-2020

GDPR Compliance

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Create better data protection policies and to hold the organizations

  • 04-February-2020

Live Webinar Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 11-April-2017

Live Webinar Pharmaceutical Quality Risk Management (QRM) Overview

By: Steven Laurenz ,Principal Consultant, Biophia Consulting Inc.

Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system.

  • 30-January-2020

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

By: Dr. Loren Gelber ,Pharmaceutical consultant.

OTC drug product for marketing

  • 09-October-2018

Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Live Webinar

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Annual Product Quality Review

  • 19-September-2018

Medical Device Recalls: How to Properly, Compliantly, and Promptly Deal with a Recall

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

PR issues for your firm

  • 19-October-2018

2018 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

How to write, organize, and maintain SOPs and train personnel

  • 27-November-2018

FDA's Expectations from Supplier Management for GMP: Quality Agreements and More

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

FDA’s requirements without creating undue burdens for the organization

  • 16-November-2018

Microsoft Access - Building a Database the Right Way

By: Mike Thomas ,Subject matter expert in a range of technologies.

Numerical data in a visual format

  • 12-February-2019

Medical Device Recalls: How to Properly, Compliantly, and Promptly Deal with a Recall

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Protects your firm from more severe action by the FDA

  • 05-November-2019

Understanding the FDA Aseptic Processing Guidance Document

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

How final drug product is aseptically processed, pharmaceutical companies can implement

  • 25-July-2019

What Did I Do Wrong? Top Violations of Law Against Physical Therapists

By: Mark R. Brengelman ,Attorney at Law PLLC.

Learn to identify the legal authority for state agencies

  • 10-April-2019

Fired by Facebook - HIPAA and social media violations of HIPAA’s privacy requirements

By: Mark R. Brengelman ,Attorney at Law PLLC.

Both when a heath care practitioner initiates a social media comment and when the practitioner responds to a social media

  • 08-May-2019

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

By: Roger Cowan ,Pharmaceutical Consultant, R Cowan Consulting Services LLC.

How environmental monitoring data is reviewed

  • 02-April-2019

Human Factors Usability Studies Following ISO 62366 and FDA Guidance

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

New ISO 62366 standard and the new FDA guidance document

  • 30-April-2019

Quality Control of Microbiological Media, Reagents and Test Kits

By: Michael Brodsky ,Lead Auditor, Canadian Association for Laboratory Accreditatio.

Practical QC approach for in-house prepared and/or commercially purchased media

  • 29-July-2019

4-Hour Virtual Seminar - Batch Record Review and Product Release

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

A strong batch record review system is essential in order to properly document

  • 20-August-2019

GxP/GMP and its Consequences for Documentation and IT Systems

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Documentation is a critical tool for ensuring GxP/GMP compliance

  • 26-September-2019

3-Hour Virtual Seminar on CAPA for Medical Devices

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

CAPA is the cornerstone of an effective Quality Management System

  • 18-September-2019

The Value of Human Factors

By: Thomas Bento ,Sr. Regulatory Consultant.

The ISO 62366 is noted by FDA as a “Consensus” Standard, making it a gold standard

  • 22-October-2019

Good Documentation Practice (GDocP) for FDA Regulated Industries

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Connection between GxP/GMP and document control

  • 23-January-2020
Back to Top