Establishing Limits for Cleaning Validation
Cleaning validation is a key part of pharmaceutical, biopharmaceutical, and medical device manufacturing. One of the critical steps in performing a successful cleaning validation is establishing the limits of residue that can remain on the surface being cleaned.
During the webinar, we will explore approaches to establishing limits for cleaning validation, specifically looking at the areas of product grouping, sampling methods, detection methods and calculating limits.
Instructors: Paul Lopolito and Michael Gietl
Paul Lopolito is a technical services manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to critical environment and process research cleaners, which includes field support, site audits, training presentations and educational seminars. Paul has over 15 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. Paul is a frequent speaker at industry events including the PDA, ISPE, INTERPHEX, AALAS, and IVT. Paul has published several articles and book-chapters related to cleaning and cleaning validation. He earned a B.A. in Biological Sciences from Goucher College in Towson, MD.
Michael Gietl is a Technical Service Specialist for the Life Sciences Division of STERIS Corporation (Mentor, OH). He currently provides global technical support related to Sterility Assurance Products and Process Cleaners including field support, site audits, and training presentations and educational seminars. Michael has 9 years of industry experience in a cGMP regulated environment holding positions in Quality and Validation.
Michael has specific experience working in the quality unit of bulk active pharmaceutical ingredient (API) manufacturing with direct experience in the development and validation of analytical test methods and the validation of process cleaning methods. Michael earned a B.S. in Chemistry from the University of Missouri in Columbia, MO and an M.B.A. from the University of Missouri in St. Louis, MO. He also holds certifications as a Six Sigma Green Belt and Quality Manager.