Pharmaceutical GMP Auditor/Lead Auditor Training

Key Course Information

Who will the course benefit?

Our Pharmaceutical GMP Auditor/Lead Auditor 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 formal auditor training.  The course may be used as part of Continual Professional Development (CPD) of many quality professionals.

So that we can give the delegates the right amount of time and attention – we limit this course to a maximum of 10 delegates (live on-line interactive VIRTUAL courses) or 12 delegates (in-person CLASSROOM courses).

The course can also be used for UK based Responsible Persons (RPs), as part of the training requirement to become a Responsible Person for Import (RPi).

Pre-course knowledge:

It is recommended that attending delegates have an appreciation of the standards covered during the course, but this is not essential.

This includes knowledge of the requirements of ICH Q10 (plus ICH Q8 and ICH Q9) and a basic knowledge of Eudralex Volume 4 (European Union GMP).  There is some pre-course work associated with the course that will cover this.  This is included in the course price.

Course accreditation:

Our Pharmaceutical GMP Auditor/Lead Auditor Course is approved by IRCA (The International Register for Certificated Auditors) and meets their current PQMS Auditor/ Lead Auditor training course requirements.

On successful completion of this course delegates may begin registration with IRCA as an internationally recognised auditor of Pharmaceutical Quality Management Systems (PQMS). IRCA course reference number – A17632.

Assessment:

Delegates are assessed by continuous assessment throughout the course and a final examination. Our final examination success rate is currently 95%. The IRCA average success rate for standard Lead Auditor courses is 76.5%. In the event of failing the final examination, we offer free support and a free examination re-sit.

Examination:

The final course examination lasts for 120 minutes.  An additional 20% of the time allowed (24 minutes) if English is not a delegate’s first language.  An additional 30% of the time (36 minutes) is allowed for specific disabilities.  For VIRTUAL courses the exams are invigilated online, in a small group, within a few weeks of taking the course. 

The exact dates will be arranged in the weeks leading up to the course.  The exams will be recorded.  For CLASSROOM-BASED courses, the examination takes place on the final afternoon of the course, at the course venue.

Course Details

Click on the tabs below for more details on the content of the Pharmaceutical GMP Auditor/Lead Auditor Course:

Course 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.

The Pharmaceutical GMP Auditor/Lead Auditor 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.

Also included in the course is 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 Pharmaceutical GMP Auditor/Lead Auditor course explains the role of the auditor to professionally audit a modern Pharmaceutical Quality Management System (PQMS) and on successful completion of the course can be used as part of registration with IRCA (see later) to become an internationally accredited pharmaceutical auditor.

The Pharmaceutical GMP Auditor/Lead Auditor Course covers the principles of auditing Pharmaceutical Quality Management Systems (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.

During the course there are many exercises and workshops to put the lessons learnt into practice.  There is also a final examination at the end of the course.

The course also includes our “world famous” audit simulation exercise.  Here, the delegates are split into small groups of auditors and they audit our fictitious pharmaceutical company called Drumley’s. 

They audit this organisation to GMP, to evaluate them as a potential contract manufacturer.  There is a video and over 300 documents, procedures and records that can be looked at.  The tutors become members of the company being audited. 

NEW TO 2024 – we have enhanced the audit experience by welcoming trained actors, adding further depth to the characters within Drumley’s and giving you, the delegate, an even more realistic view of the world of auditing. 

As part of this audit simulation exercise, the auditors need to present their findings, at a closing meeting, including what their overall recommendations are.

Quality Management Systems:

• The latest FDA and EU GMP thoughts on Quality Management Systems.

• The requirements of GMP, ISO 9000 and their inter-relationship

• The structure and legal status of EU and USA GMP

• GMP and Quality Management

• The requirements of GMP and the importance of product quality and the patient

• Performing audits to GMP

• Auditing the Warehouse, Production, Packaging and Laboratories

• Auditing systems – Training, Internal Audits, Management Review, Deviations, Complaints, CAPAs

• The importance of getting to the root-cause of the problem

Auditing Suppliers:

• Supplier standards (API GMP, Excipient GMP and Packaging Suppliers Standards)

• Auditing to Good Distribution Practice (GDP)

• The evolving role of Quality Assurance – thinking about more than product quality

• The enhanced role for Senior Management within a Pharmaceutical Quality Management System

• ICH Q8, 9 and 10 and their role in a modern forward thinking pharmaceutical company

• Using audits to promote continual improvement

• Thinking beyond GMP and product quality – business quality and performance

• Organisational efficiency, effectiveness and continual improvement

Auditing:

• Reasons for first, second and third party audits – using them effectively

• How to plan, execute, report and close-out internal and external audits

• Opening and closing meetings

• Auditing Senior Management and their commitment to the system

• How to perform audits professionally

• Audit simulation exercise – with pharmaceutical facility video and over 300 documents and records to review

• Auditing functions, departments and processes

• Good auditing techniques

• Checklist construction

• Auditing for compliance to GMP

• Getting to the root-cause of a problem

• Adding value as an auditor

• How to conduct audits that promote increased process performance

• ISO 19011 guidelines for quality and management systems auditing