Profile
Chris Clark
Director and Consultant
Chris has over 38 years experience of Quality Control / Quality Assurance within the pharmaceutical and other regulated life sciences industries. For 15 of those years he was Head of Department at Napp Pharmaceuticals Limited and is an experienced leader of teams responsible for ensuring compliance to international GxP’s. Chris is an internationally recognized expert in the area of computerised systems validation through his leadership roles in the ISPE / GAMP® Community of Practice, has a Degree in Biochemistry from Lancaster University and is a member of the Chartered Quality Institute (CQI).
Areas of Expertise
In his role as Head of Quality Assurance, Chris was accountable for validation strategy and approach, and actively participating in the validation of many types of pharmaceutical equipment, processes and systems. He has specialized experience in ensuring compliance of a wide range of computerised systems. Projects have include:
- MRP systems
- Documentation Management systems
- Laboratory systems
- Clinical systems
He has assisted an IT service provider to develop a quality management system to support IT Service Management (ITIL®). These roles have helped him develop 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 Co-Chair of the ISPE GAMP® Global Steering Committee, Chair of the GAMP® Editorial Board and a member of the GAMP® Europe Steering Committee. Chris contributed to the GAMP® interpretation of the revised Annex 11 and to many of the GAMP® Good Practice Guides.
Chris has extensive experience of speaking at many international seminars and conferences on the risk-based approach to compliant GxP computerised systems.
Profile
Heather Watson
Director and Consultant
Heather has over 30 years’ experience of Computer System Quality Assurance and Compliance within the pharmaceutical industry working for GlaxoSmithKline where she held several roles in various areas of the company, including Global IT Risk Management, Human Resources Computer Systems, Global Quality Assurance Document Management Systems and Director, Computer Systems Quality Assurance, Pharma R&D. Heather is an experienced leader of subject matter experts responsible for ensuring compliance to international GxP’s.
Areas of Expertise
In her role as Director, Computer Systems Quality Assurance, Heather was responsible for developing and implementing strategy, policy and objectives that fundamentally raised the importance of computer system quality/compliance within GSK Pharma R&D; identified potential computer compliance risks by interpreting changes in the internal and external regulatory environment and translating the impact to GSK; provided line management for a team of subject matter experts responsible for delivering programs relating to project support, inspection readiness, internal company audits, external supplier audits, communication and education and also delivering the computer system assessment program by providing strategy and direction to a dedicated global matrix team.
She is an internationally recognized expert in computerized systems validation through her leadership roles in the ISPE / GAMP® Community of Practice, and is currently Chair, GAMP Global Steering Committee and a member of the GAMP Europe Steering Committee. She has extensive experience of speaking at many international seminars and conferences on the risk-based approach to compliant GxP computerized systems. Heather is an Author of ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition).