Webinar: What You Need To Know About Annex One

In this 2023 webinar from NSF’s Lynne Byers, we look at the critical updates of the Annex One Revision, offering quality professionals a comprehensive understanding of its implications for the pharmaceutical and biotech industries.

Key Issues Discussed:

•Evolution of Annex One: Explore the significant changes from the 2008 version to the current 59-page document, highlighting the collaborative efforts of international regulatory bodies.

•Clarifying Misconceptions: Address common misconceptions regarding the application of Annex One principles to non-sterile products and the role of quality risk management.

•Contamination Control Strategy: Understand the consolidation of contamination control elements into a comprehensive strategy and how to design an effective plan tailored to specific manufacturing needs.

•Pharmaceutical Quality System (PQS) for Sterile Products: Learn about the expectations for PQS in sterile product manufacturing and how to align existing systems with Annex One requirements.

•Regulatory Expectations and Compliance: What do regulators expect from companies in terms of awareness, planning, and implementation of Annex One provisions.

NSF Can Help:

Stay up to date with important regulatory and compliance changes by speaking with an expert from NSF.

Click here to request a call with a member of our expert team:
https://www.nsf.org/contact-us

Stay up to date by taking an NSF training course. Find out more here:
https://www.nsf.org/training/area/hea...

Our team of ex-regulators and industry experts can help. Find out more here:
https://www.nsf.org/life-sciences/pha...


Further Reading on the NSF website:

•What You Need to Know About the Annex 1 Revision:
https://www.nsf.org/knowledge-library...

•White Paper: Why Annex 1 Is Important to You:
https://www.nsf.org/knowledge-library...

•Annex 1 Revision Published, FDA Biosimilar Workshop & More: https://www.nsf.org/news/september-ph...

•How to Develop an Effective Contamination Control Strategy:
https://www.nsf.org/training/series/d...