Process Validation, planning, strategy, requirements, risk assessment, design description

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.

Areas Covered in the seminar:

• What are the areas that must be covered and what are the timings?
• How you can build a program to meet regulatory requirements and be a valuable business resource?
• How to break it up into manageable chunks and build strong protocols and reports?
• How do you tie it all together to end up with a strong defendable program?
• Avoid the everything is critical trap.
• The difference between good process development and process validation.
• Who does what in the program?
• Not everything has to be done at the end - timing is everything.
• What a good process development program can deliver to aid in process validation?

Who will benefit:

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.

• QA and Complaince staff
• Process development staff
• Manufacturing staff
• Validation
• Regulatory affairs staff
• Project managers

Instructor Profile:

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..

Follow us :