Process Validation - Life Cycle Approach ( WEBPVLIFE )
Process Validation is the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Grace McNally, FDA, will discuss and review the goals of the 2011 Final Guidance on Process Validation, the various stages of the lifecycle approach and key recommendations, cGMPs and Process Validation (PV) for drug manufacturing, legacy products and process, terminology, as well as the major concerns about the 2008 Draft and response.
FDA Process Validation Guidance
At the conclusion of this session, participants will be able to:
Read a related article in the May/June PE for additional insight:
click here to read the article, which begins on Page 2. Also, we will be featuring an exclusive interview with Grace McNally in the July/August issue with good behind-the-scenes info on the Guide.
Who should attend: Production Managers, Bioprocess Engineers, QA and Regulatory Affairs Managers
Presenter Biography Grace McNally,Consumer Safety Officer, FDA, USA
Grace McNally is a Senior Policy Advisor in CDER’s Office of Compliance, Division of Manufacturing and Product Quality, Guidance and Policy Team and currently is Acting Branch Chief for Recalls and Drug Shortage within DMPQ. Previously, she served as a Compliance Officer handling domestic CGMP cases. She is active on several Guidance working groups dealing with process validation, combination products and revisions of the CGMPs, as well as developing training for FDA and industry. Prior to coming to CDER she was a field investigator in ORA’s Denver District, specializing in pharmaceutical and medical devices inspections. McNally began her FDA career in Philadelphia District before moving to Colorado to assume the Recall and Complaint Coordinator position in the Denver District. After two years in that capacity she returned to inspectional work in the drug and device arena. She graduated from Boston College, Chestnut Hill, MA.