Pharmaceutical Lead Auditor Course

This unique 5-day course is highly recommended for anyone concerned with the quality management systems operated by suppliers of starting materials to the pharmaceutical industry. It has been developed and run over many years in the UK, Europe and the Far East

The course is based on GMP as it relates to starting materials and specified in the PS 9000 series of standards and ISO 15378. PS 9000 applies to contact and secondary packaging and printed components such as labels and patient information leaflets; PS 9100 specifies graded levels of GMP for inactive materials dependent upon their use (e.g. liquids for eye drops would have the same level as the GMP used by the pharmaceutical manufacturer, oils for external ointments would have a lower level of GMP). ISO 15378 is International Standard for Primary Packaging Materials. These standards have been developed over more than 15 years and are published in the UK by the Pharmaceutical Quality Group of the Institute of Quality Assurance (IQA) and the International Standards Organisation (ISO 15378). The PQG is is made up of quality executives from most of the major pharmaceutical companies and their suppliers. There is an associated certification scheme for company registration. The UK medicines regulator endorses the PS 9000 series and some of its inspectors have attended the course.

The course is designed for Quality Assurance, Quality Control and Purchasing Professionals from Pharmaceutical Companies and Suppliers. It is also very useful for auditors from third party certification bodies. In the UK, delegates have attended from BSI, DNV and SGS. The course is highly recommended to existing and intending Qualified Persons (QPs) as part of their Continuous Professional Development (CPD). It is not essential, but recommended that delegates have some prior knowledge of the ISO 9000:2000 series and PS 9000 & PS 9100 before attending the course. We can help with this if required.

The course is registered by the International Register of Certificated Auditors (IRCA) and meets their training requirements for registration as Auditor and Lead Auditor. Successful delegates will not only obtain invaluable experience and skills in auditing suppliers against the new standards, they will obtain a qualification which is internationally recognised. This puts them on the same or a higher level of recognition than many customer and certification body auditors.

Benefits To Your Business

The company benefits are significant. The MHRA, FDA and other regulators report that the major causes of recalls of pharmaceutical products are due to purchased items. It is therefore imperative that supplier audits are done professionally so that you get a thorough understanding of how quality of critical supplies are managed. IRCA registration also confers a professional auditing status on individuals, which is recognised by customers and regulators worldwide.

Course Structure

Instruction and auditing practice are provided in a series of build-up modules. The tutor(s) are practising third and second party lead auditors and auditors and experienced trainers who use the latest accelerated learning techniques. This involves the delegates in practical learning exercises throughout the course. Experience has shown that compared to the traditional U shaped table and slide presentation approach, this technique improves delegate attention and knowledge retention and significantly improves pass rates on the IRCA set written test.

Successful completion of the Lead Auditor course fulfils the training requirements, but the regulators also require demonstration of successful auditing for registration as Auditor and Lead Auditor. We offer a service of accompanying the auditors, usually on audits of their suppliers, and in addition to providing our own auditing experience will endorse the audit log sheets and other registration documentation.

Abbott Laboratories, AstraZeneca, Aventis, Avecia (previously ICI), Boehringer Ingleheim, The British Pharmacoepia, The British Standards Institute (BSI), Ciba Geigy, Courtaulds Betts, Novartis, Cox Pharmaceuticals, Det Norske Veritas, Field Boxmore Healthcare Packaging, Fauldings, Ferring Pharmaceuticals, GlaxoSmithkline (GSK), Medica Packaging, MY Healthcare, Norton Healthcare, Rhone Poulenc Rorer, Rexham Pharmaceutical Packaging, Roche Products, Roussel, Sanophi Synthelabo, Serologicals, Taiwan Healthcare Executive, The UK Medicines Inspectorate

Comments from Delegates

The following are some of the comments from delegates who have attended the course:

“Superb explanation of the PS 9000 series of GMP standards and how to audit against them”

More Information

Next Course Date: 7th - 11th June 2010

Course Venue: The Bailbrook House Hotel, Bath

The cost of the public course is £1,885 + VAT. This includes lunch and refreshments during the course, a comprehensive set of reference materials and complete bound audit checklists against the special requirements of PS 9000 and PS 9100.

To book a place please fill out the booking form and send it back. For further information, please contact us on +44 (0) 1249 44 75 44 or complete our Enquiry form

Discounts are available for multiple bookings. We can arrange overnight accommodation (at extra cost) to suit your budget.

The course is held in selected hotels in Bath or can be held in your facilities with considerable savings. A limited amount of tailoring (usually at no extra cost) can be done on in house courses.