About us
Roger Chapman is an internationally recognised expert in the interpretation and application of OECD Good Laboratory Practice to the full spectrum of regulatory studies, both in the laboratory and in the field. He also has extensive experience of Good Clinical Practice in the laboratory (GCLP), and Good Manufacturing Practice in the Quality Control laboratory environment.
A long-serving former Senior Quality Assurance Manager in the Contract Research industry, Roger has developed a tremendous depth of experience in compliance problem-solving. He has also led or participated in over 70 regulatory inspections from the MHRA, FDA and EPA, and has developed and maintained GxP quality systems and audit programmes for over 30 years.
Roger is a regular speaker at regional, national and international conferences and an established trainer/facilitator on professional development courses covering Quality, Compliance and Quality Assurance.
Key skills include:
- Expert Quality Assurance auditing
- Compliance-focused audits and clear, succinct report writing
- Full spectrum of GxP expertise, including laboratory, field and clinic
- Risk-based Quality Assurance
- Innovative audit programme design, development and implementation
- Regular conference speaker and established trainer/facilitator
- Training programme design, delivery and evaluation
- CAPA and Process Improvement
- CAPA programme owner and reviewer
- Positive continuous improvement driver
- GxP advice and regulatory compliance problem solving
- Pragmatic GLP, GCP and GMP solutions
- Multi-site study specialist, including handling Sponsor/ CRO interfaces
- Computer Systems Validation and auditing
- Risk-based CSV protagonist
- SOP design and management
- Champion of clear layout, active voice and alternate media inclusion
- eQMS and Audit Management systems
- TrackWise and in-house software super-user
- Software configuration and implementation project director