Significant Change - Learn how to identify and evaluate changes involving the manufacture of pharmaceutical excipients that may impact the drug formulation and when it is expected that the pharmaceutical customer will be notified of the change.
Gain awareness of:
- The "What" - A uniform approach to significant changes in manufacturing and distribution of excipients
- The "Whys" - Importance and benefits of a uniform approach to significant change
- Impact of changes on excipient quality and performance
- The "Hows" - Understanding and applying the requirements set forth in the IPEC Significant Change Guide, including
- 2014 updates to the Guide
- Reasons behind the updating of the Guide
- Major differences between the versions
- When to use Risk Assessment to assess a change
- Examples of specific changes and their categorization as "Significant" or "Not Significant"
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.
Manager within the Technical Operations departing of McNeil Consumer Healthcare focusing on raw materials. She has worked in the Pharmaceutical Industry for 11 years in Process Development, Technical Transfer and Raw Material Evaluation roles. She currently Vice Chairs the IPEC Americas Excipient Qualification Committee.