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Process Validation and The CQV Lifecycle(s): Where do we stand?

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New approaches for conquering diseases and improving our overall well being have been driving new technologies at a faster rate in the last 20 years.  This in turn have triggered changes in regulatory environments, leading to changes in the guidelines from the main regulatory agencies around the world.  The guidelines for process validation have not been an exception, as they have evolved from the original “V-model” to the current and much wider definition of process validation.  The different names given by the actual validation practitioners reflect their intended purpose: Validation Lifecycle, Process Validation Lifecycle, CQV Lifecycle. But are these the same?  Which areas of the lifecycle have experienced the most changes and which ones have remained within the “traditional” scenarios?  And, more importantly, have we reached the desired agility regarding Process Validation (in its wider use of the term) for us to demonstrate that the technologies and practices used to manufacture the newest type of dosage forms are consistently reproducible?  This webinar will discuss Validation, Qualification and Process Validation from a wider perspective, showing what elements have remained true to their original purpose from a regulatory standpoint and which have started to evolve to adjust to today’s biopharmaceutical landscape.

 

Participants will learn about:

  1. The fundamental concepts of commissioning, qualification, and validation (CQV)
  2. The evolution of qualification and validation into a Process Validation Lifecycle and/or CQV Lifecycle
  3. The key regulations and guidelines on validation and qualification from the main regulatory agencies and professional organizations around the world
  4. The different approaches to maintain the validated state… and prove it!
  5. How Validation and Qualification ties to other Quality Systems
  6. The use of Risk Management in the execution of validation and qualification exercises
  7. The importance of “pre-validation”, characterization, and exception Management as keys to an AGILE execution of the CQV Lifecycle
  8. How to face and handle unexpected events (e.g. deviations and exceptions; despite having done the proper “pre-validation” work)
  9. A Case Study showing the application of current approaches to CQV and the lessons learned a year later
  10. Strategies for successfully adapting the existing and recent trends in CQV to the newer technologies and practices in the biopharmaceutical industries

Click Here to Register

 

 

Speakers

Gerardo Gomez

Senior Business Development Manager, ECHO Consulting Group, A PharmaLex Company

Gerardo is a dynamic professional, with over 25 years of experience in the Pharmaceutical and Biotechnology industries. He is recognized as a Subject Matter Expert in the areas of Validations, Technology Transfer, Investigations/CAPA Systems, Sterile Product Manufacturing, Aseptic Processes, and Lyophilization. Gerardo held senior management positions at various Fortune 100 biopharmaceutical companies before joining PharmaLex, initially as a Sr. Consultant and Project Manager, and now as a Sr. Business Development Manager. He has also taught university level courses in Pharmacy and Business Schools, both at graduate and undergraduate programs. Gerardo is a superb public speaker, with a natural ability to engage the audience into participating in the subject presented, to enhance the learning experience.

Gerardo graduated Magna Cum Laude from the Chemical Engineering department at the University of Puerto Rico, and earned his Ph.D. in Pharmaceutics from the University of Michigan.

Specialties: Pharmaceutical and Biopharmaceutical Manufacturing Processes, Root Cause Analysis, Process Validation, Lyophilization, Aseptic Processes, Quality Systems, Regulatory Sciences, Technical Writing.