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:
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.