IRCA registered Pharmaceutical Auditor/Lead Auditor Training Course
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IRCA Registered Pharmaceutical Auditor/Lead Auditor Training Course

Course Description
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 Chartered Quality Institute (CQI) 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.

Who Should Attend?
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,LRQA 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 9000:2000/8 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 in the pharmacutical sector 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.


 
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Key Details
Duration5 days
 
£2,100
per delegate
 
 
Bookings Helpline: 01933 233884 (Monday to Thursday - 8:00am to 5:30pm and Friday 8:00am to 5:00pm).