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Validity : 13th Apr'24 to 23rd Apr'24
FDA Internal Complaint Handling
- 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
Overview of the webinar
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
Who should attend?
- Directors
- Managers
- Supervisors in Regulatory Affairs
- Manufacturing Personnel
- Quality Assurance and Clinical Operations Personnel
- Regulatory Affairs
- Marketing
- Medical Affairs
- Legal
- Regulatory Compliance
Why should you attend?
This webinar will address approaches to setting up an internal complaint handling system that ensures compliance with all GMP requirements.
Faculty - Ms.Peggy J.Berry
Peggy J. Berry, MBA, RAC, is the president and CEO of 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).