Pharmaceutical GMP Auditor/Lead Auditor training course

Course overview:

This is a unique course, focusing on auditing to GMP, pharmaceutical supplier standards and the latest ICH Q10 requirements for Pharmaceutical Quality Management Systems. This is the longest running such course of its type, with the tutors presenting this or equivalent courses for over 12 years. It is arguably the highest regarded IRCA registered Pharmaceutical Lead Auditor course available and continues to receive unrivalled feedback from attending delegates.

This course explains the role of the auditor to professionally audit a modern Pharmaceutical Quality Management System.

The course covers current principles on Pharmaceutical Quality Management Systems (PQMS) and includes the FDA's "Guidance for Quality Systems" and ICH Q10 "Guidance on Pharmaceutical Quality Systems". These guidelines explain the evolving nature of pharmaceutical quality thinking, with a focus on organisational processes, their effectiveness and efficiency as well as the importance of product quality and GMP. We also include the ramifications for Top Management within a pharmaceutical company following the recently updated EU GMP Chapter 1 on Pharmaceutical Quality Management Systems and Chapter 2 on Personnel.

Delegates will leave the course with a clear understanding of how to successfully integrate GMP, ICH Q8, 9 & 10 and ISO 9000 principles into a compliant, effective, efficient and continually improving quality system for the whole business, as well as the role of the auditor and "Quality Personnel" in re-shaping quality thinking to move with the times to meet today’s business challenges.

For full course details go to main website.

VAT will not be charged for courses held outside the UK. VAT will be charged for the courses held in the UK, however delegates from outside the UK but within the European Union (EU) will not be charged VAT if they supply their own company's national VAT number when booking. VAT will not be charged for any delegates coming from outside the EU.

The cost of accommodation is not included in the course cost. If required you should book accommodation yourself directly with the hotel. It is recommended that delegates stay at or close to the course venue.

Course Times:

This is an intensive course with assessments throughout. The timings are as follows:

Day 1: 09.00 – 18.45 Days 2, 3 & 4: 08.30 – 18.30 Day 5: 08.30 – 16.30 (includes final examination) There is also about an hour’s evening work each night.