Pharmaceutical GMP Auditor/Lead Auditor Training with Inspired Pharma
Overview
This is a unique training course for pharmaceutical auditors who will audit against pharmaceutical Good Manufacturing Practice (GMP) and/ or audit suppliers to pharmaceutical manufacturing sites. The course trains auditors how to professionally plan, perform, report and follow-up internal and supplier audits and is set in a pharmaceutical context throughout the whole course.
Key topics covered
- The course covers the requirements of European Union GMP (EU GMP), including the requirements of ICH Q9 and 10, and how these are used as the main reference base when auditing pharmaceutical manufacturing sites.
- An overview of key standard for suppliers to the pharmaceutical industry, including ISO 9001, Active Pharmaceutical Ingredient GMP (API GMP), Excipient GMP, Packaging Supplier Standards as well as Good Distribution Practice (GDP) and how these should be used when auditing suppliers.
- The role of the auditor to professionally audit a modern Pharmaceutical Quality Management System (PQMS) as detailed in GMP and also the FDA’s “Guidance for Quality Systems” and ICH Q10 “Guidance on Pharmaceutical Quality Systems” as well as the requirements of EU GMP itself.
Who should attend
The course is aimed at internal and supplier auditors along with key personnel involved in Quality Assurance and Quality Management Systems. The course will also benefit those involved in the purchasing of incoming materials and individuals who look after the whole supply chain. Additionally, the course is ideal for trainee Qualified Persons (QPs) as well as existing auditors who have had no forma auditor training. The course may be used as part of Continual Professional Development (CPD) of many quality professionals.
What do Attendees Obtain on Completion?
Attendees are assessed by continuous assessment throughout the course and a final examination. Attendees will receive a certificate of completion.
Register
Course Format
Onsite at NIBRT
5 full days onsite training at NIBRT facility
This course is booked directly through the Inspired Pharma website. Click buy product below and find NIBRT course under ‘Course Dates’. Select course: Dublin Mon 16 Jun – Fri 20 Jun 2025
Price £3500 GBP plus VAT
Dates & Price
Dates:
- 16/06/2025 - 20/06/2025
