Review of IPEC-Americas most recently updated Significant Change guide.
- 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 2014 IPEC Significant Change Guide, including
- A review of the newer parts to the guide and important things that changed in the 2014 version
- When to use Risk Assessment to assess a change
- Examples of specific changes and their categorization as "Significant" or "Not Significant"
Bretta Lichtenhan is Head of Pharma Registrations within the Regulatory organization of the Life Science division of MilliporeSigma. She manages a global team of regulatory experts, focused on regulatory registration of products such as excipients, active pharmaceutical ingredients (APIs), highly potent APIs, linkers, antibodies & antibody-drug conjugates, and pharmaceutical materials for the (bio-) pharmaceutical industry. She is currently Chair-Elect of IPEC-America’s and has previously held roles within the association such as Vice Chair of Administrative affairs and chair of the Excipient Qualification Committee. Bretta has also been actively involved in the planning of ExcipientFest Americas (now Excipient World), for the last several years. She has over 20 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 9 years in various roles from R&D Product Development, Product Management, Regulatory Affairs and Business Development. Bretta has a bachelor’s degree in Biology from the University of New Hampshire and Master of Biotechnology Engineering from Tufts University.
Heather’s current role is Sr. Manager, Raw Materials Strategy within the Global Technical Operations department of the Johnson & Johnson Family of Consumer Companies focusing on technical aspects of raw materials and raw material qualification. She currently leads a global team and manages the raw material portfolio within the Self Care sector of Johnson and Johnson. She has worked in the Pharmaceutical Industry for 15+ years in Process Development, Technical Transfer and Raw Material Evaluation roles. She currently Vice Chairs the IPEC Americas Excipient Qualification Committee, is the Vice Chair of User Relations, and is heavily involved in the education committee for IPEC’s ExcipientWorld.