Phyllis Walsh presents a comprehensive overview of the USP and the various publication and standards they have developed. A deep dive into USP General Chapters, General Notices and the role of monographs in the US will also be explored. She will also review the working compendial relationships with other organizations such as the Pharmacopoeia Discussion Group (PDG), European Pharmacopoeia (Ph. Eur.) and the Japanese Pharmacopoeia (JP) and how IPEC views the future of harmonization.
- Recognize the role of the USP and the law
- Understand excipient requirements in USP-NF
- Harmonization – The Future
- Navigate the USP website
- Have an overview of how to work with USP
Ms. Walsh is an Associate Director, Compendial Compliance and Advocacy at Merck & Co. Inc. She has 38 years of experience at Merck/Schering-Plough Corporation in quality control, analytical development and compendial affairs. In her role in Compendial Compliance and Advocacy she provides expertise and guidance in all aspects of the compendial issues to ensure compliance with the compendia. She handles correspondence with the compendia. She is a liaison between Merck and the compendia, and also provides guidance to Merck sites on compendial requirements.
Currently Ms. Walsh is on IPEC-Americas Executive Committee as the Vice-Chair for Harmonization and Compendial Monographs and Chair of IPEC – Americas Compendial Review / Harmonization committee.
She is a member of New Jersey Pharmaceutical Quality Control Association (NJPQCA) and served as chair of the NJPQCA Compendial Discussion Group for 14 years. She represented NJPQCA on USP Excipient Project Team, USP Process Improvement Project Team and the USP General Chapter Project Team which she served as chair. Also, she was a member of the USP Advisory Group on Elemental Impurities. She is a member of Coalition on Elemental Impurities.