Now that Risk-MaPP has become accepted by drug regulatory agencies, companies that wish to operate according to the Guide’s prescription for a health-based approach to cleaning validation must present full justification and documentation for the Acceptable Daily Exposures (ADEs) they develop. This webinar will teach participants how to develop an ADE monograph that will pass muster with regulatory agencies.
Documentation should include the background and purpose of the document, sources of data, key data element summaries, and a detailed explanation of how the ADE value was derived.
This presentation differs from previous Risk-MaPP offerings by containing a closer, more focused look at the derivation of the ADE. We will discuss real-life case studies of experiences with regulatory authorities, and shed light on what regulatory agencies are looking for in ADE monographs.
At the conclusion of this session, participants will be able to:
Presenter Biography Robert G. Sussman, Ph.D., DABT, SafeBridge Consultants, Inc., US
Dr. Sussman is currently the Managing Principal of SafeBridge Consultants’ Eastern Operations. He has over 20 years experience in the pharmaceutical industry where he has worked in various capacities in corporate occupational toxicology groups for Warner-Lambert and Pfizer. Bob has an undergraduate degree in Bioenvironmental Engineering from Brown University and a Ph.D. in Environmental Health Science from NYU. He is a Diplomate of the American Board of Toxicology, a past member and chair of the AIHA’s WEEL Committee, and a founding member of the Occupational Toxicology Roundtable. He also has an adjunct appointment at the NYU Medical Center.
Who should Attend:
Quality Assurance, Pharmaceutical Engineers, Toxicologists, Regulatory Affairs, or anyone involved in the preparation and regulatory submission of ADEs