FDA Internal Complaint Handling

Peggy J Berry

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$249

Premier price: $224 (save 10%)

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Join this webinar to learn approaches to setting up an internal complaint-handling system that ensures compliance with all GMP requirements.

Why Should You Attend:

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Attend to learn the approaches to setting up an internal complaint handling system that is in compliance with all GMP requirements.

Areas Covered in the Webinar:

  • Review of GMP requirements for complaint handling
  • Types of complaints that may be received
  • Tracking the complaint from time of receipt
  • Initiating and performing a complaint investigation
  • Review of the complaint and investigation
  • Preparing a response to the complainant
  • Preparation of an associated SOP

Who Will Benefit:

This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to good manufacturing practices.

  • Quality assurance personnel
  • Quality control staff
  • Clinical Operations
  • Regulatory Affairs personnel
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Premier price: $ 539 (save 10%)

Recorded video

Recorded video session

Premier price: $ 314 (save 10%)


Speaker: Peggy J Berry,

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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646 905 0515

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212-751-3500