Excipients: Compliance with Compendial and GMP Requirements

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

Excipients must be evaluated with each drug they are included with to ensure that they can be used safely

  • 21-January-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Good Documentation Practice (GDocP) for FDA Regulated Industries

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Connection between GxP/GMP and document control

  • 23-January-2020| 10:30 AM ET | 07:30 AM PT | 09:30 PM CT Duration 90 Minutes

FDA Regulations for Analytical Instrument Qualification and Validation Processes

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

Global agencies expectations of analytical equipment qualification along with the development

  • 28-January-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Standard Operating Procedure e-Book (Step-by-Step Guide)

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

The participants how to write, maintain, and update SOPs to ensure compliance

  • 28-January-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Live Webinar Pharmaceutical Quality Risk Management (QRM) Overview

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

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

  • 30-January-2020| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

GDPR Compliance

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Create better data protection policies and to hold the organizations

  • 04-February-2020| 10:30 AM ET | 07:30 AM PT | 09:30 PM CT Duration 90 Minutes

Tools for Human Error Reduction

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

Tools for measurement and Key Performance Indicators

  • 25-February-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Incoterms® 2020 Rules

By: Jan Seal ,International Trade Consultant.

Latest developments in commercial practice

  • 03-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

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.

  • 05-March-2020| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Vendor selection is a serious process. Manufacturers are responsible for compliance with their selected vendors

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

what qualifies a foreign vendor and what disqualifies a foreign vendor

  • 12-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

Developing a Strategic Approach to FDA Compliance for Computer Systems

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

detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC)

  • 12-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Good Manufacturing Practices Training | GMP Course

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

We will review how all of this work should be documented

  • 18-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Data - Governance, Risk, Compliance

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Documentation is a critical tool for ensuring GxP/GMP compliance

  • 24-March-2020| 10:30 AM ET | 07:30 AM PT | 09:30 PM CT Duration 90 Minutes

How to write SOP's that Avoid Human Error

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

Development to formats designed for human error reduction

  • 26-March-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks

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

How to apply consistent Meta tags and policies to all documents and records

  • 07-April-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

FDA’s Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

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

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act

  • 09-April-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

4-Hour Virtual Seminar on Good Laboratory Practices (GLPs) vs GMPs – Comparison and Contrasts

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

Good laboratory practices (GLPs) and good manufacturing practices (GMPs)

  • 07-May-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 240 Minutes

Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements

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

Both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning

  • 19-May-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

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

Understand in detail Computer System Validation (CSV)

  • 07-July-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

FDA Compliance and Mobile Applications

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

for planning, executing or managing the implementation of any system governed by FDA regulations

  • 10-September-2020| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
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