Stability Protocols for Development and Commercial Products

  • Product Id : FDB2337
  • Category : , ,
  • Presenter :
  • Scheduled On : April 09 2018 4:00 pm
  • Duration : 90 Minutes

This training program will discuss the requirements of ICH and the FDA for stability protocol content and format, including special stability studies required for approval.

This webinar will demonstrate to attendees how best to create stability protocols for drug substance and drug product, including long term stability; accelerated stability and special stability studies (e.g., light or oxygen sensibility).

Areas Covered in the Session :

  • Creating stability protocols
  • Shipping protocols
  • ICH and FDA specific requirements
  • Updating the FDA with data during development and commercial phases
  • Changing expiry dating with more data
Who Should Attend:

  • Manufacturing Departments
  • Supply Chain Departments
  • Technical Operations Departments
  • Quality Control Departments
  • Quality Assurance Departments
  • Regulatory Affairs Departments


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).



  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance