Presenter:

Bob Adamson, is a consultant with RBQ Services Limited and former manager of pharmaceutical compliance with Foster Wheeler in Reading, U.K., where he is responsible for all compliance and validation services.He has more than 30 years of experience in the pharmaceutical industry including positions with Foster Wheeler, Beecham, and Glaxo, and experience in R&D, production management for APIs, and sterile manufacturing. He has been responsible for the start-up of new facilities and a number of major refurbishments. He is a chartered chemist and chartered chemical engineer. At Foster Wheeler his recent experience has included compliance and regulatory topics, validation of oral and sterile dosage forms, and biotechnology and API facilities to meet EU, FDA, and MHW requirements.Bob has worked with a wide variety of clients and on occasions has represented them at FDA meetings. He is an active Member of ISPE and has written and presented a number of papers and contributed to a number of books. He has been involved with ISPE’s commissioning and qualification initiative since its conception, is currently Co-chair of the CoP Steering Committee, and is ISPE’s project manager for the development of Baseline® Guide Volume 12 Science and risk based approach for the delivery of Facilities, systems, Equipment and associated automation.  He was elected U.K. Fellow of the Year in 2003, and has been past chair of the U.K. Southern Region and is the Chair elect of the U.K. Affiliate taking over April 2009.

Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8, Q9, and Q10 and ASTM E-2500. Topics covered include the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process; producing high quality products and consistent operation to meet product user requirements. Guidance on the transition of an organization’s approach to Commissioning and Qualification to one that incorporates a science and risk-based approach will be discussed.This course was developed by members of the ISPE Commissioning and Qualification COP.  Immediately apply the course objectives using the complimentary copy of the ISPE Good Practice Guide: Applied Risk Management for Commissioning and QualificationNOTE: It is strongly recommended that participants should be familiar with basic concepts of commissioning and qualification prior to attending this course. CPIP™ Technical Knowledge and Competency ElementsThis course contains knowledge related to the CPIP™ technical knowledge competency element Facilities and Equipment: Commissioning and Qualification. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.Who should Attend?

• Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science and Risk-based approach.
• Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory.

Take Back to Your Job

• Explain the relationship between ICH Q9, ASTM E-2500, ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment and the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification.
• Discuss the information necessary to develop Requirements Documents that will support a science and risk based approach to qualification. Given the necessary information and a list of requirements, identify those that are necessary for product quality and those that are business / safety related.
• Apply risk management methodologies throughout design and verification phases. Explain the link between risk assessments, design review, and quality risk management.
• Understand and examine the development of a Verification Strategy that incorporates use of vendor testing, construction quality assurance, site acceptance testing, installation checks, and functional testing.
• Know what is involved in a system Acceptance and Release report given requirements, critical aspects, and verification test results in compliance with a verification strategy.
• Outline the use of GAMP®5 principles in support of system delivery of a packaged system inclusive of mechanical and control system elements.
• Summarize US / EU / SFDA / and WHO regulatory requirements and expectations that may influence application of a science and risk based approach.