About the webinar
This webinar describes the use of QRM (quality risk management) in Cleaning Validation and the growing trend of applying this approach to the lifecycle of the product manufacturing process. Establishing of health-based Cleaning Validation limits and using them in MAC equations is also included. Additionally we will discuss recommendations on the compliant and sustainable programs and regulator expectations for these programs. Cleaning Validation is a regulatory requirement as well as expectations. In addition, a robust and compliant cleaning validation program makes perfect business sense for successful manufacturing facilities. The webinar will cover :
Cleaning Validation Guidance -
Establishing Health Based Limits
Quality Risk Management
Capability of Sampling results
Treatment of censored data
MAC Equations based on HBEL's
MAC per Sample Point
MAC Evaluation
Selecting MAC / VRL
About the Presenters
Susan B. Cleary, B.Cs, M.B.A., is the Director of Product Development at Novatek International. Susan has 20 years of experience in designing, developing, implementing, and managing large scale LIMS, Quality Management, and Cleaning Validation Management software implementations. She has talked in various forums like PDA, ISPE, Pharmig through North America and Europe also contributes in PDA handbook and PDA TRAI.
Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth, and Shire. He is currently holding a position of Senior Consultant at Concordia Valsource, LLC. He had published articles and white papers in pharmaceutical professional magazines and textbooks. He is very active with PDA participating in several Task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation) and 60 (Process Validation). He is leading PDA Water Interest Group.