Current regulatory thinking on CSV and Data Integrity : The Key to FDA and GMP Compliance

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

  • 01-October-2018  To 02-October-2018 - Singapore

Current regulatory thinking on CSV and Data Integrity : The Key to FDA and GMP Compliance

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

This interactive two-day workshop planned by WCS provides attendees the opportunity to interact with a Data Integrity Subject Matter Expert.  Filled with numerous case studies

  • 11-October-2018  To 12-October-2018 - Boston,MA

Live Webinar FDA Labeling Requirements

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

  • 04-April-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar Good Documentation Practices for FDA-Regulated Computer System Validation

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

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

  • 19-April-2017 | 00.00 AM

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 | 00.00 AM

Live Webinar Audit – An Essential Tool for Continuous Improvement

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

  • 18-April-2017 | 00.00 AM

Live Webinar Quality System Management Effectiveness

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

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

  • 12-April-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar Medical Device Trends for Computer Systems Regulated by FDA

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

  • 05-April-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar Good Documentation Practices – Real World Application

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

  • 10-January-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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

By: José Mora ,Principal Consultant.

Lean Documents and Lean Configuration

  • 07-June-2018 | 00.00 AM

Live Webinar FDA vs Health Canada

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

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

  • 06-August-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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

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

This training will introduce the concepts associated with implementing a carefully defined technical and business governance programs along with clearly defined R&D to site transfer

  • 21-June-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar Medical Device Trends 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 60 mins Live Webinar

  • 14-June-2017 | 00.00 AM

Live Webinar Equipment Validation, Tracking, Calibration and Preventive Maintenance

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

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment

  • 23-June-2017 | 00.00 AM

Live Webinar Process Validation: Principles and Protocols

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

This webinar explains the regulatory requirements for process validation

  • 06-July-2017 | 00.00 AM

Live Webinar Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence

  • 11-July-2017 | 00.00 AM

Live Webinar CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

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

Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management

  • 12-July-2017 | 00.00 AM

Live Webinar Management Controls Under FDA QSR and ISO 13485

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

  • 02-October-2017 | 00.00 AM

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 | 00.00 AM

Live Webinar Good Documentation Practices for FDA-Regulated Computer System Validation

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

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

  • 26-March-2018 | 00.00 AM

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 | 00.00 AM

3 hours Webinar: 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 3 Hrs Live Webinar

  • 29-September-2017 | 00.00 AM

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 | 00.00 AM

Live Webinar Regulatory Submissions all Part of CMC

By: JERRY DALFORS ,Principal, JD Technologies.

  • 26-September-2017 | 00.00 AM

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 | 00.00 AM

Live Webinar Qualification of contract manufacturer organizations based on practical experience

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

Attendees will receive “A 6 page Pre-Audit Questionnaire and a 25 page CMO audit form”

  • 27-September-2017 | 00.00 AM

Live Webinar Implementing a Change Control Quality System Successfully

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

  • 05-October-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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

  • 02-August-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar Biosafety and Blood borne Pathogen Safety in the Lab

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

This webinar will review the regulations and guidelines recommended by the Centers for Disease Control and Prevention

  • 03-October-2017 | 00.00 AM

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 | 00.00 AM

Live webinar: U.S. Export Documentation and Procedures

By: Jan Seal ,International Trade Consultant.

Keep current with the changes that have taken place with the export regulations including changes in 2018

  • 24-April-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

How to Evaluate Payroll Provider Vendors and Minimize Implementation Nightmares!

By: Margie Pacheco Faulk ,Sr HR Consultant, HR Compliance Solutions.

All companies with 50 or more employees must ensure compliance with federal, state and local regulations. It is difficult to navigate the employment law reporting

  • 27-September-2017 | 00.00 AM

Risk Based Approach to 21 CFR 11 ER/ES & Validation of Computer Systems

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

This Hands-On course will provide the attendees with both a strategic and a tactical understanding of how CSV fits into all aspects of the Life

  • 27-September-2017 | 00.00 AM

Live webinar: International Letters of Credit

By: Jan Seal ,International Trade Consultant.

A letter of credit is one method of payment used in international trade transactions.

  • 19-September-2017 | 00.00 AM

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 | 00.00 AM

Live Webinar Regulatory Submissions all Part of 510K

By: JERRY DALFORS ,Principal, JD Technologies.

FDA BRIEFING Documents

  • 06-September-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

3 Hrs Webinar on 505(b)(2) NDAs By Peggy J. Berry, (Ex FDA)

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

What is a 505(b)(2)

  • 14-November-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Critical Factors when Developing an Employee Handbook That Protects Your Company!

By: Margie Pacheco Faulk ,Sr HR Consultant, HR Compliance Solutions.

Did you know that Employee Handbooks can be a risk or a benefit for Employers? For years an Employee Handbook has been one of the

  • 19-October-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar FDA Focus:Purchasing / Supplier Controls for Medical Devices

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

Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls.

  • 18-October-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar How to write SOP's that Avoid Human Error

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

SOP writing outline

  • 24-January-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar European Data Protection Regulation – 2018 Implementation

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

European Data Protection Regulation

  • 03-July-2018 | 00.00 AM

Live Webinar Medical Device Complaints and Corrective and Preventative Action (CAPA)

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

This CAPA webinar for Medical device will guide you how CAPA and complaint handling should interact in Medical Device, and Identifying the root cause of

  • 14-March-2018 | 00.00 AM

Live Webinar Technical Training in the Life Sciences

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

Training and Development has its own body of knowledge and a wide range of techniques and approaches designed to meet unique and complex training challenges

  • 12-January-2018 | 00.00 AM

Live webinar Medical Device Industry Trends for Computer Systems Regulated by FDA

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

The Webinar will focus on the importance of managing FDA oversight of computer system validation

  • 21-March-2018 | 00.00 AM

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

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

FDA's 21 CFR Part 11 guidance

  • 22-March-2018 | 00.00 AM

Live Webinar Customs and Trade Partnership Against Terrorism (C-TPAT) Compliance

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

C-TPAT program overview including “Tiered” strategy

  • 07-February-2018 | 00.00 AM

Live Webinar Current FDA Laws and Regulations on Radiation-Emitting Products and Radiation-Emitting Electronic Products

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

Current FDA Radiation Control Laws

  • 08-March-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar How to conduct Annual Product Reviews to achieve GMP Compliance

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

Learn how to write APRs

  • 19-September-2018 | 00.00 AM

Live Webinar Understanding and Implementing a Quality by Design Program

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

The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised.

  • 02-May-2018 | 00.00 AM

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 | 00.00 AM

Live Webinar Understanding and Implementing a Technology Transfer Process

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

Identify New Product transfer process

  • 27-June-2018 | 00.00 AM

Live Webinar Designing An Effective Cleaning Validation For Reusable Medical Devices In Today's Regulatory Environment

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

FDA expectations regarding reusable medical device design considerations

  • 28-February-2018 | 00.00 AM

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

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

Gain an understanding of disaster recovery and business continuity planning

  • 26-February-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar FDA Compliance and Mobile Applications

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

understanding of computer system validation planning, execution and management concepts

  • 02-May-2018 | 00.00 AM

Live Webinar Regulatory Requirements for Registration of Medical Device Products in China

By: David R. Dills ,Global Regulatory Affairs & Compliance Consultant and President, NovaQual.

CFDA Regulatory Approval Process and Timelines

  • 20-March-2018 | 00.00 AM

Live Webinar Product Complaints: Complaint Handling From Intake To Closure

By: David R. Dills ,Global Regulatory Affairs & Compliance Consultant and President, NovaQual.

If the complaint triggers a Medical Device Report (MDR), ensure that the complaint file is clearly identified or maintained separately from other complaint files

  • 09-March-2018 | 00.00 AM

Live Webinar MEDDEV 2.7.1, Revision 4 for Clinical Evaluation and the Latest 2016 Guideline: A Guide for Manufacturers and Notified Bodies

By: David R. Dills ,Global Regulatory Affairs & Compliance Consultant and President, NovaQual.

Introduction to MEDDEV 2.7.1, Revision 4 (2016)

  • 26-February-2018 | 00.00 AM

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 | 00.00 AM

Live Webinar Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

By: David R. Dills ,Global Regulatory Affairs & Compliance Consultant and President, NovaQual.

When does a complaint become a reportable event?

  • 01-April-2018 | 00.00 AM

Live Webinar Establish and Maintain an Effective Supplier Qualification Program

By: David R. Dills ,Global Regulatory Affairs & Compliance Consultant and President, NovaQual.

Discuss and review Supplier Agreements

  • 01-April-2018 | 00.00 AM

Live Webinar FDA’s Final Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List

By: David R. Dills ,Global Regulatory Affairs & Compliance Consultant and President, NovaQual.

This Webinar will provide latest update as well as a “refresh” overview on how to register your device company and list your device(s) correctly and

  • 22-May-2018 | 00.00 AM

Live Webinar Construct and Manage the Technical File and Design Dossier

By: David R. Dills ,Global Regulatory Affairs & Compliance Consultant and President, NovaQual.

A brief summary of manufacturing processes (flow chart including inspection and preventive monitoring steps) and validation of sterilization processes should be included in the design

  • 12-June-2018 | 00.00 AM

Live Webinar Understanding and Applying the New EU Medical Device Regulations (EMDR)

By: David R. Dills ,Global Regulatory Affairs & Compliance Consultant and President, NovaQual.

The New EU MDR — Are You Really Ready? Your Roadmap to World-Class Implementation of Europe’s New Medical Device Regulation. You have 3 years to

  • 08-May-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

3 hrs Webinar 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.

  • 04-April-2018 | 00.00 AM

3 hrs Webinar - Tools for Human Error Reduction: Developing Metrics and KPI's (Key Performance Indicators) to minimize Human error rates

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

Understand human error: factors and causes

  • 08-May-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Electronic Records & Electronic Signatures

  • 01-April-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar 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.

webinar presents a fresh new approach based upon solid principles and proven practices – as well as an alternative, applies the Theory of Lean Documents

  • 05-April-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar Building effective project teams

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

Building the project team

  • 16-July-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

How the FDA are Trained for Medical Device Inspections

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Listing Regulation (21 CFR 807)

  • 13-July-2018 | 00.00 AM

Analytical Methods Validation for FDA Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

To enhance Analytical Method Validation

  • 05-September-2018 | 00.00 AM

Data Integrity – FDA’s Latest Thinking

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Data be reliable and accurate.

  • 08-November-2018 | 00.00 AM

Auditing for Microbiological Aspects of Pharmaceutical Manufacturing

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

Microbiological aspects of manufacturing

  • 27-September-2018 | 00.00 AM

How to properly investigate OOS result

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

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

  • 02-August-2018 | 00.00 AM

Labeling, Advertising, and Promotion in an FDA Regulated Environment

By: David R. Dills ,Global Regulatory Affairs & Compliance Consultant and President, NovaQual.

Fair balance as between benefits and risks

  • 07-August-2018 | 00.00 AM

Implementation and Management of GMP Data Integrity

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

Data integrity is assuming greater importance in CGMP for US FDA regulated industry

  • 21-August-2018 | 00.00 AM

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 | 00.00 AM

Computer System Validation

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

Testing, based on risk

  • 11-October-2018 | 00.00 AM

Implementing a Robust Supplier Management Program

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

A robust, yet efficient

  • 26-September-2018 | 00.00 AM

Analytical Method Validation and Transfer

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

Hands-on” knowledge of the method validation process

  • 05-September-2018 | 00.00 AM

Establishing a Robust Data Integrity Program

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

Data over its entire life-cycle

  • 03-October-2018 | 00.00 AM

What to do if you receive a FDA-483, Inspectional Observations Form

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

483 if there is clear communication with the Investigator

  • 07-September-2018 | 00.00 AM

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 | 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

Live Webinar Strategies for Avoiding Employment Discrimination Claims

By: Janette Levey Frisch ,Employment/HR Attorney| Founder, Law Office of Janette Levey Frisch|The Employer's Legal Wellness Professiona.

This webinar will familiarize you with and sensitize you to the key pitfalls to be aware of and avoid and provide you with some practical

  • 10-October-2017

3 Hours Webinar : How to Survive an FDA Food Facility Inspection ?

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data

  • 23-July-2018

Live Webinar Preventing economically motivated adulteration (EMA)

By: Dr. Michele Pfannenstiel ,President and CEO of Dirigo Food Safety..

In this webinar you’ll learn what EMA is, why you should care, how it pertains to your regulated products

  • 06-March-2018

Live Webinar The Requirements and Responsibilities of a HIPAA Security/Privacy Officer

By: Howard Jones ,President of HJones & Associates LLC.

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

  • 28-March-2017

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

Risk of Objectionable Microorganisms in Bio-Pharmaceutical Manufacturing

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

Objectionable microorganisms

  • 11-October-2018
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