Stability Protocols during development & commercialization

Live Webinar
Date: Thursday September 13, 2018
Time: 11:00 AM ET | 8:00 AM PT
Duration: 90mins with Q&A

This webinar will teach you to create stability protocols for drug substance and drug product, including long term stability; accelerated stability & special stability studies (e.g., light or oxygen sensitivity).

Learn the recommendations of ICH for stability protocol content and format, including special stability studies required for approval.

Areas Covered During The Session

  • Contents of stability protocols
  • Shipping protocols
  • ICH recommendatons will be discussed
  • Updating  data during development & commercial phases
  • Capitalize
  • Set expiration date based on data

Peggy J. Berry, MBA, RAC, President & CEO, Synergy Consulting 

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).

Target Industry

Pharma & Biotech

Target Job Title
Quality Assurance, Quality Control (Chem and Mirco), Process and Design Engineering, Process Automation, Manufacturing Operations, Validation, Utility Operations, Regulatory Affairs.

Register Today!

 

Single Registration
Single Attendee: $195.00 + HST CAD per session
Single attendee refers to single participant at a single computer/login.


Group Registration
Group of 5 or less per location: $400.00 + HST CAD per session
Group of 6 to 10 attendees per location: $750.00 + HST CAD per session
Group of 11 to 20 attendees per location: per location: $1250.00 + HST CAD per session

Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.


Please contact us at enquiry@ipacanada.com for any other enquiries.