This webinar will walk through the elements of a process validation program for biological products with an emphasis on the involvement of all functions especially process development.
Writing the Process Validation section of the BLA is a daunting task. But before you start writing you must develop a program that delivers the results you need. A rugged process validation program builds off conventional equipment, facility and utility validation and marries it to a rugged process development program. While simple to describe many companies fall into the trap of territoriality, and confusion of roles and responsibilities. Each of the various departments plays a critical role in bringing the science, engineering, manufacturing, quality and compliance functions together to build a joint cooperative program to aid in the development and execution of a robust process validation program that will both satisfy the agency but be valuable to you are a commercial organization.
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This webinar will walk through the elements of a process validation program for biological products with an emphasis on the involvement of all functions especially process development. It will differentiate between the two disciplines (process validation and process development) and help you build a strong program that meets regulatory requirements as well as your business requirements. We will describe the pitfalls and how to avoid them.
Peter Calcott, Ph.D. is the President of Calcott Consulting, a consulting firm focused on supply chain, quality, clinical development, regulatory affairs and corporate compliance. He has over 30 years experience in the industry having positions in Quality, manufacturing, process development, compliance. He has worked for large Pharma as well as small biotechnology companies. He has licensed and introduced new products to the marketplace on 6 continents..
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