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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.
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.
Jane has over 30-years’ experience in quality assurance roles, including Quality Management positions and, encompassing a wide range of dosage forms. Dosage form experience includes metered dose inhalers, tablets, capsules, liquids, topical preparations, plus sterile products.
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.