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CPD Hours: 7
Classroom, online, in-house
It is a regulatory requirement for organisations within the Pharmaceutical and Allied Industries to audit active pharmaceutical ingredient (API) manufacturers, suppliers of key excipients and packaging materials, and contracted-out laboratory services. This course is aimed at reviewing the key relevant standards that one might expect to audit against, providing a strong foundation for the application of auditing skills. Specifically this course covers the EU GMP Parts I, II and III; PS 9000; ISO 17025; ISO 15378 and ISO 13485. Several elements of ISO 9001 (Quality Management Systems) are explored in detail.
By the end of the course you will be able to understand the structure and key requirements of:
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
A microbiologist with over 35 years experience, Andy Martin has worked in numerous QA management roles, spanning a range of sterile and non sterile dosage forms, and gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events.
Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience.
IRCA QMS lead auditor for the pharmaceutical industry
This IRCA Accredited, 5 day fully residential course, provides the most comprehensive certification for Lead Auditors in the Pharmaceutical industry