Analytical Method Validation and Transfer

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

  • 06-February-2019  To 07-February-2019 - Raleigh, NC
  • 20-March-2019  To 21-March-2019 - San Diego, CA

Latest Compliance Strategies for Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

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

  • 27-February-2019  To 28-February-2019 - San Francisco CA

2 Days Seminar FDA Trends in Compliance and Enforcement for Regulated Computer Systems

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

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance

  • 28-February-2019  To 01-March-2019 - Richmond , Virginia

Writing Effective SOPs: The First and the Most Important Step Toward Systemizing your Business

By: Angela Bazigos , CEO Touchstone Technologies Silicon Valley.

  • 07-March-2019  To 08-March-2019 - Burlingame CA

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

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

The FDA governs the computer systems used to collect, analyze, transfer and report data that is in support of human clinical trials required for drug

  • 11-March-2019  To 12-March-2019 - Philadelphia

Aseptic Processing Overview and Validation

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

  • 18-March-2019  To 19-March-2019 - San Diego CA

2 Days workshop Effective Compliance Strategies for Complaint Handling, Medical Device Reporting and Recalls

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

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall

  • 28-March-2019  To 29-March-2019 - Philadelphia

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

Off Label Promotion for Drugs & Medical Devices

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

How FDA can reconcile

  • 02-October-2018 | 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

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

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

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Electronic Records & Electronic Signatures

  • 05-December-2018

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

How to Manage Your Vendors in Clinical Research

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Current FDA regulations and ICH guidelines

  • 25-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

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

FDA’s New Import Program for 2018: Be Prepared and Be Compliant

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

FDA and U.S. Customs and Border Protection

  • 28-November-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

  • 07-November-2018

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

  • 10-December-2018

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

  • 17-January-2019

Risk Evaluation and Mitigation Strategy (REMS) Inspections

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Mitigate all the adverse events of a medication

  • 22-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

Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Criteria for methods to detect, identify and quantify all microbial analytes

  • 04-April-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

  • 02-May-2019

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

  • 06-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

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.

  • 22-April-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

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

Excel Data Visualization: Charts and Infographics

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

  • 19-December-2018
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