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Pharmaceutical requirements for self-inspections

Session outline: A collaboration between the Pharmaceutical Quality Group (PQG) and the Audit SIG, this session includes presentations on experiences of self-inspection (internal) audits in the pharmaceutical industry, including the Management of Corporate Risk and Practical Implementation.

Creator: CQI (Uploaded 18 February 2025)

Date of recording: 11 February 2025

Duration: 1 hour 4 minutes

Price: Members – free, Non-members – £10

Richard Brett CSci CChem MRSC CQP MCQI. Richard was employed in the pharmaceutical industry for 46 years and is now retired. He worked in R&D, Quality, Compliance and Audit roles at site, regional, central and corporate levels. He has 18 years' experience of auditing internal and external manufacturing and supply operations from development through to commercial supply, reviewing the management of product quality and supply continuity risks and issues. He also has 25 years' experience in consultation, including organising and leading training programmes and workshops, project support, and helping sites prepare for regulatory inspections. Richard was a founder member of the CQI Audit SIG and is currently the Vice-Chair.

 

Phil Butson BPharm MSc FRPharmS FRQA MCQI CQP. Phil is a committee member and former Chair of the CQI Pharmaceutical Quality Group (PQG). Phil has worked in the pharmaceutical industry for over 35 years, starting in product development, then moving into clinical trial supply operations before taking on his first Quality Assurance role in 1993. He is eligible for nomination as a GMP Qualified Person and has experience as a site Head of Quality and various global quality leadership roles in a major international pharmaceutical company, including engagement in several industry expert groups and networks. He has presented on a wide range of topics for professional bodies and has also been involved in publications, including as author/editor of the PQG monographs on auditing and good distribution practice.

Price: £10.00
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