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The concepts of what should be included in Quality Agreements have been explained in the 2009 IPEC Quality Agreement Guide and Templates. However, with new regulatory requirements and more complex supply chains, the Guide was recently revised by a team of IPEC experts to provide practical and detailed guidance on how to meet current challenges.
- Familiarize yourself with appropriate content of an excipient Quality Agreement
- Understand the major changes to the guide revision
- Familiarize yourself with the contents of the Quality Agreement Templates
- Understand the innovative concept of Manufacturer’s Quality Statement template
Bretta manages a global team of regulatory experts, focused on regulatory registration of products such as active pharmaceutical ingredients (APIs), highly potent APIs, linkers, antibodies & antibody-drug conjugates, excipients, and pharmaceutical materials for the (bio-)pharmaceutical industry. She is currently Vice Chair of Administrative Affairs on the IPEC-Americas Executive Committee and has previously chaired the Excipient Qualification Committee. Bretta has also been actively involved in the planning of ExcipientFest Americas, for the last several years, a conference focused on excipients. She has over 19 years of experience in the industry with previous experience at Biopharma companies Genzyme (a Sanofi Company) and Percivia LLC. Bretta has worked for MilliporeSigma for over 8 years in various roles from R&D Product Development, Product Management, Regulatory Affairs and most recently, Business Development. Bretta has a bachelor’s degree in Biology from the University of New Hampshire and Master’s of Biotechnology Engineering from Tufts University in the United States.