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"
Regulatory Surveillance and Advocacy Manager for North America within EMD Millipore’s Global Regulatory Management Division. She has worked for EMD Millipore for 5 years in various roles from Technology and Product Management to her current role in Regulatory Management. Bretta currently chairs the IPEC Americas Excipient Qualification Committee and is also member of the IPEC Americas Executive Committee.
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.