Process Validation for Biological Products - Fitting PV into Process Development and QbD with New Regulations

Instructor: Peter Calcott
Product ID: 702105
  • Duration: 90 Min

recorded version

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This Process Validation training for biological products will provide valuable assistance on how to integrate the PV work into your development program using QbD in light of the issuance of new regulations by the FDA.

Course "Process Validation for Biological Products – Fitting PV into Process Development and QbD with New Regulations" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

In this webinar, we will present the regulations governing process validation and its execution and how it is interpreted for biological products, particularly how the new guidance can be implemented to your advantage. We will show how to link together the process development studies and exercises into a compliant process validation program and into batch records that will satisfy the regulators, by investing in a more comprehensive submission by using the elements of Quality by Design.

In addition, the many peripheral studies that are required for biological products will be described. We will outline the common errors that companies make in their program design and illustrate this with real life examples from FDA Warning letters so you will not make the same mistakes yourselves.

Areas Covered in the Seminar:

  • Why biological products are more complex than classic drugs and why Process Validation is more of a challenge?
  • And understand what the regulations state and how they apply to biologicals?
  • How to link together Process Development and Process Validation to yield an effective batch process for your biological?
  • How to link together the many validation studies from cell banking to vialing of products?
  • What peripheral studies are required by agencies?
  • How to use Quality by Design strategies to your advantage in submissions?
  • Some of the traps companies fall into developing and executing a Process Validation Program.
  • Where companies make costly errors with agencies so you do not have to?

Who Will Benefit:

This webinar will provide valuable assistance to all companies that develop and license biological products in the USA and EU where process validation is a requirement for approval. The employees who will benefit include:

  • Senior management and executives
  • Quality Assurance
  • Quality Control
  • Compliance
  • Manufacturing
  • Process development
  • Validation
  • Supply Chain and Logistics
  • Regulatory Affairs
  • Project Managers working in the CMC arena

Instructor Profile:

Peter Calcott, Ph.D. is founder and President of Calcott Consulting which serves the biotech, pharma and venture capital industry. It provides consulting services in supply chain, quality systems, clinical development, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.

He has held positions in industry in all these disciplines over a 30 year career. He has presented at national meetings and is active in the biotechnology community via BIO and the bay area BayBio trade associations where he has been the chairman of the BIO RAC committee and is presently a Board member of BayBio.

Topic Background:

While the regulations for process validation are common for both drugs and biologicals in the major markets, how it is approached is very different.  Biologicals are characterized by products that are very complex in nature, difficult to manufacture and require extensive characterization and testing.  These multistep manufacturing processes lend themselves to process validation exercises but it is rather the linkage between them that is the challenge.

In addition, regulators require peripheral studies, not encountered with classic drugs, to demonstrate process performance and these pose special challenges of execution partly because the process environment can result in product degradation, contamination and inactivation.  Judging by the number of Warning Letters issued in the last several years, companies still find this requirement difficult to meet.  With the new guidance recently released, the situation will get tougher.

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