Do you want to perform audits for your organisation? If so, you are an ambassador for your company, and so it is essential that you perform these audits professionally. Our 5-day Pharmaceutical GMP Auditor/ Lead Auditor training course covers how to effectively plan, perform, report and follow-up pharmaceutical auditsagainst a range of pharmaceutical standards, including GMP, API GMP, Excipient GMP, Packaging Supplier Standards and GDP.
Plus, the course is registered with IRCA, so you can become an internationally registered pharmaceutical auditor. Our final examination success rate is currently 95%. The IRCA average success rate for standard Lead Auditor courses is 76.5%.
Why not attend this highly praised and prestigious course, which has been used for training approaching 1,000 pharmaceutical auditors over the past 10 years?
Who will the course benefit?
Our 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 12 delegates.
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.
Course contents:
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)
- The Falsified Medicines Directive and Good Distribution Practice
- 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 role-play 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
