Our Pharmaceutical Training Portfolio Auditing – External (2-day)
Auditing – Active Pharmaceutical Ingredients (1-day)
This course provides the basic knowledge base and skills to enable effective auditing and reporting of audits on those suppliers of active pharmaceutical ingredients (APIs). The course is focused on the requirements of ICH Q7 and EU GMP Part II and the expectations of regulatory bodies both in the USA and Europe.
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It is a regulatory requirement for organisations to audit active pharmaceutical ingredient (API) manufacturers, suppliers of key excipients and packaging materials, and contracted-out laboratory services. This course provides an introduction to the skills and processes necessary to perform effective external auditing and follows those details described in ISO 19011 - the international standard for auditing.
More specifically, the course focuses on those standards and guides used by external suppliers to the pharmaceutical industry – EU GMP Part II, PS 9000 and the IPEC-PQG GMP Guide for excipients manufacturers, the EXIPACT™ certification standard for excipients manufacturers and distributers, GCLP and ISO 17025. Several elements of quality management systems (ISO 9001) are explored in detail which help build knowledge and confidence in this universally recognised standard on which many of the above are based. Delegates will learn and practice how to plan, execute, report and close-out external audits including writing non-conformity reports.
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Auditing – Internal (2-day)
This course provides an introduction to the requirements of internal auditing described in the international standard ISO 19011. Frequent opportunities to practice key steps are provided through role play in a no risk environment, with supportive feedback provided throughout. The course is focused on pharmaceutical GMP and several subjects are explored in detail which helps build up knowledge and confidence in GMP. The range of other standards appropriate to external auditing (e.g. GDP, ISO 9001) are described briefly but not explored in depth.
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“A less formal, more personal approach to training.”
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