Roger Chapman is a highly regarded expert in the interpretation and application of OECD Good Laboratory Practice (GLP) across a wide range of regulatory studies, both in laboratory and field settings. He possesses significant expertise in Good Clinical Practice (GCLP) within laboratory environments and Good Manufacturing Practice (GMP) in Quality Control labs.

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With a long-standing career as a Senior Quality Assurance Manager in the Contract Research industry, Roger has amassed extensive experience in compliance and problem-solving. He has played a pivotal role in over 70 regulatory inspections conducted by the MHRA, FDA, and EPA, and has been instrumental in developing and maintaining GxP quality systems and audit programs for more than three decades.Roger is a frequent speaker at various conferences, both nationally and internationally, and is a seasoned trainer and facilitator for professional development courses focused on Quality, Compliance, and Quality Assurance.

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Key Skills:

• – Expertise in Quality Assurance auditing
• – Conducting compliance-focused audits and producing clear, concise reports
• – Comprehensive GxP knowledge, including laboratory, field, and clinical settings
• – Designing and implementing risk-based Quality Assurance audit programs
• – Regular conference speaking and training facilitation
• – Designing, delivering, and evaluating training programs
• – Leading CAPA programs and driving process improvements
• – Providing pragmatic solutions for GLP, GCP, and GMP challenges
• – Specializing in multi-site studies and managing Sponsor/CRO interfaces
• – Validating and auditing computer systems, with a focus on risk-based approaches
• – Designing and managing SOPs
• – Championing clear communication and innovative media use
• – Managing eQMS and Audit Management systems, with expertise in TrackWise and custom software configurations.