Annex 1 Initiative

The Chief Quality Officer Team commissioned the work of the Annex 1 Initiative to benchmark ways to implement the new Annex 1 requirements and expectations. The team met from July 2022 - October 2022, and generated a benchmarking report for open source access. The team continues to meet, exploring many facets of the Annex 1 document.

Meet the Team: The team members involved in the benchmarking work are provided below. These members are also externally engaged in other industry forums, but found this work to exclusively dive into the “how to” that is not being addressed elsewhere.

The report includes high level key takeaways, but if you are interested in joining this team for on-going deep dive discussions, let us know (intended for company employees, not consultants and service providers). The team meets for 1 hour, every other week (Tuesdays from 10:30am - 11:30am Eastern), and will continue meeting throughout the year!

• Pete Berzins, Eli Lilly

• Brent Conatser, Elanco

• Lisa Davis, AstraZeneca

• Ian Hudson, Thermo Fisher

• Alfred Kutor, Elanco

• Barbara Moser, CSL Behring

Annex 1 Digital Transformation of CCS

Description: Annex 1 revisions have been extensive, and companies are working to implement the requirements while interpretting new expectations.  Access this recorded session to explore how to lead a true digital transformation as part of your Contamination Control Strategy.

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