Project & Quality Training International

Marcel Schakel has attended the HLO Medical Biology and subsequently more than 25 years experience in the (bio)Pharmaceutical, Medical Devices industry and hospital sector. Marcel has worked in various functions as (Chief-) Technician, Manager Operations, Senior Quality Assurance Officer and Validation Manager. He has gained a broad range of knowledge in Quality and Project's. Marcel works in the field of Project and Quality Management and is now an independent consultant, firm name PQM Consultancy.

Marcel has a lot of experience to Commissioning & Qualification and Validation of computer systems, IT infrastructure, processes and cleaning. But he is also very experienced in all aspects Quality Management Systems (e.g. GxP, ISO, Medical Devices, CCKL), Data Integrity, Document Control, Review of Raw Data, Change Management, CAPA Management, Risk Management, internal and external Auditing.

Marcel has a wide range of knowledge in the above areas. He participated in the steering committees of the ISPE Project Management CoP BeNeLux, ISPE GAMP CoP BeNeLux and ISPE Commissioning, Qualification & Validation CoP BeNeLux and is also member of several professional other organizations.

Mobile: +31 (0) 6 49022609
E-mail: Marcel.Schakel@PQTInternational.com

René is a very experienced and intelligent consultant in the field of process improvement, process automation, system selection and design. Beside that, due to his large experience in the execution of projects (from design, implementation and project management) he is capable of leading a large group of people in engineering teams or customer project teams.

For a large number of years he specialized in pharmaceutical projects.

René is efficient and very effective, thinks fast and analytical.

René is an ISA trainer for ISA-95, ISA-88 and project management and teaches GAMP.

René founded an ISPE Community of Practice for Process Analytical Technology and for Good Automation Manufacturing Practices for the pharmaceutical industry in the Benelux.

René is president for ISA, Netherlands section.

René is six sigma black belt and works with statistical software model to improve batch processes.
René is certified as PRINCE 2 Practitioner.

Mobiel: + 31 (0) 6 53630698
E-mail: Rene.Opstal@PQTInternational.com