Chris Clark has over 36 years experience of Quality Control / Quality Assurance within the pharmaceutical and other regulated life sciences industries. He is an experienced leader of teams responsible for ensuring compliance to international GxP’s.
Chris has specialized experience in ensuring compliance of a wide range of computerized systems (Laboratory systems, MRP systems, Documentation Management systems, Clinical systems) and has assisted an IT service provider to develop a quality management system to support IT Service Management (ITIL®). He has a proven track record of IT Vendor and services audits.
Chris is a contributor of ISPE’s GAMP® 5 Guide A Risk-Based Approach to Compliant GxP Computerized Systems, and is the Chair of the GAMP® Editorial Board, Co-Chair of the ISPE GAMP® Global Steering Committee, and a member of the GAMP® Europe Steering Committee. Chris contributed to the GAMP® interpretation of the revised Annex 11.
Chris has extensive experience of speaking at many international seminars and conferences on the risk-based approach to compliant GxP computerized systems.