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CPD Hours: 7
Classroom, online, in-house
When auditing Active Pharmaceutical Ingredient (API) manufacturers, there is a responsibility to ensure patient safety. This course provides the assurance required to meet both product safety and regulatory expectations.
This course provides the knowledge and skills to enable effective auditing and reporting of audits on 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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This course will be assessed and certified by RSSL against the standards of ICH Q7. At the end of the course you will:
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
With extensive knowledge of business operations and processes, manufacturing operations, logistics, printed packaging and pharmaceutical industry applications, David Abraham has worked in and alongside working parties at national and international level, developing guidance and standards for the industry. He has been instrumental in the development of the PS 9000 publications.
IRCA QMS lead auditor for the pharmaceutical industry
This 5 day IRCA Accredited fully residential course, provides the most comprehensive certification for Lead Auditors in the Pharmaceutical industry. Accredited by IRCA and PQG.