The FDA’s Grace McNally will speak at the ISPE Process Validation Conference, taking place at the Sheraton Silver Spring Hotel in Silver Spring, MD, October 17–18.
McNally will speak about the FDA view of lifecycle approach implementation status and its application to legacy products. Her discussion will address recent process validation-related FDA warning letters and progress implementing the lifecycle approach to process validation in the industry and at FDA. McNally will also speak about interpretation of key aspects of the FDA Process Validation Guidance. Her presentation will be followed by a brief question-and-answer session, during which attendees can get direct answers to their questions about the FDA’s updated standards for process validation.
McNally’s presentation will be part of a two-day educational program focusing on practical implementation of the lifecycle approach to process validation. The conference will feature case studies and practical examples designed to teach attendees methods for saving time and money. Delegates will learn to utilize practical guidance for selecting and justifying an appropriate number of process validation batches and determining their stage three post-process validation manufacturing monitoring plan.
For more information on the ISPE Process Validation Conference, including detailed agendas and registration information, visit www.ISPE.org/2012ProcessValidation.