Free to attend for IPEC members!
Date and time: Thursday 28 May - 10:00-11:00 CEST / 9:00-10:00 BST
This webinar will focus on Stability Studies for excipients, including the recently reissued IPEC Stability Guide for Pharmaceutical Excipients, Version 3 and its key changes.
The primary goal of the IPEC Stability guide is to:
- offer best practice and guidance in the establishment of an excipient stability programme;
- provide excipient manufacturers with strategies for assessment of overall stability;
- provide an approach for a manufacturer to establish a stability study programme which may be used to support regulatory filings;
- provide support in maintaining the quality of the excipient;
- define and substantiate recommended storage conditions and shelf-life claims (e.g., re-evaluation date, expiration date, and use- by date).
What you will learn
Industry best practices for:
- Bracketing / matrixing for families of compounds
- Stability considerations for different types and classes of excipients
- Bulk storage conditions and sampling
- Accelerated, ongoing and transportation stability studies
- Expiration / retest periods
- Specifications / tested attributes for stability studies
- Differences between excipient and API stability requirements
Who should attend
- Excipient manufacturers, users, distributors
- Regulatory affairs
- Quality affairs
- Research and Development
- Formulation
- Manufacturing and Supply Chain
Presenters
Sandra Millet, Pharma Standard Specialist - Pharmaceutical - Roquette
Adrian Bone, Senior Advisor, IPEC Europe
