Science and Risk Based Commissioning and Qualification Approach (Recorded)

This presentation discusses the challenges and benefits of applying a science and risk based commissioning and qualification approach within a contract manufacturing organization, presented by Frank van der Steen, SynCo Bio partners. At the end of this session, you will be able to:

  • Understand company details
  • Understand C&Q Transition Challenge
Frank Van Der Steen
Owner/Principal Consultant
FVCS
Instructor

Frank van der Steen has worked within the pharmaceutical industry for over 15 years mainly in the field of validation. Since 2012 Frank is the owner of FVCS, a company which provides validation support and consultancy services. Prior to starting FVCS, Frank held the position of Validation Manager at SynCo Bio Partners BV, a medium sized CMO located on the outskirts of Amsterdam, The Netherlands. In this position he was responsible for the company's commissioning & validation program; including the transition to a risk and science based approach to C&Q by implementing the principles described in ASTM E2500. Before joining SynCo Bio Partners, Frank has held the positions of validation project lead at Skanska Pharmaceutical Ltd., as a commissioning and validation engineer at Fluor Ltd. working on client projects within Europe and the USA. Furthermore, he has worked at AMT BV, a start-up gene therapy company, and Centocor BV as a manufacturing operator and technical support technician. Frank is an active Member of ISPE, has been co-chair and chair of the C&Q COP Steering Committee, and participant in the generation of several ISPE publications.

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