Comparability Protocols for Approved Drugs

Attend this training to determine whether or not a comparability protocol will provide you with future advantage in product life-cycle management. 

Peggy Berry
Instructor:
Peggy Berry
Date:
Monday, November 4, 2019
Time:
10:00 AM PST | 01:00 PM EST
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502750

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
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Overview:

This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission.

The information obtained will enable completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure which can be designed to save time and money in the future.

Why should you Attend: Attend this training to determine whether or not a comparability protocol will provide you with future advantage in product life-cycle management.

Areas Covered in the Session:

  • Is a Comparability Protocol Required
  • When is a Comparability Protocol Appropiate
  • What are the Benefits of Submitting a Comparability Protocol
  • What is the Format and Content
  • What is the Timimg of Submission
  • What is the Format and Content

Who Will Benefit:
  • Quality Assurance
  • Quality Control (Chem and Micro)
  • Process and Design Engineering
  • Process Automation
  • Manufacturing Operations
  • Validation
  • Regulatory Affairs


Speaker Profile
Peggy J. Berry ,MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).

She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).




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