Pharmaceutical auditing courses now part of IQA's prestigious 2003 quality training programme
It has become apparent that the greatest causes of recalls in the pharmaceutical industry are the faults in purchased products, not the medication itself. Wrong labels, printing errors on packages and errors on the patient leaflets, resulting from ineffective implementation of PS 9000 and PS 9100, the standards for pharmaceutical packaging and excipients, all contribute to the level of extensive recalls.
The Institute of Quality Assurance (IQA) has teamed up with an established training provider, Jeff Monk Training to deliver complementary training against PS 9000 Pharmaceuticals Packaging Materials and PS 9100 Pharmaceutical Excipients, which lay the foundation for proper supplier auditing and control. The end result is a one stop offering in which the industry's audit teams can not only become fully familiar with the new standards, but individual members can obtain an internationally recognised qualification.
IQA is in the unique position of being able to offer the only split/two stage pharmaceutical auditing course in the UK, designed to accommodate individuals' work commitments and operational needs. Pharmaceutical content is integrated throughout each of the five days, ensuring specific industry focus.
The course, which is approved by the International Register of Certificated Auditors (IRCA), is delivered by two certified QMS and PS 9000 auditors with third party auditing experience. The trainers use a variety of methods from tutorials to practical workshops to provide information on the requirements and application of the standards and instruction of carrying out in-depth audits against them.
So far audit teams have been trained and qualified from most of the major pharmaceutical companies and the Medicines Control Agency. Courses have been run in Europe and the Far East.
Whilst the pharmaceutical industry itself is subject to regular and intense scrutiny by the regulators, their suppliers do not come under this statutory control. It is the responsibility of the pharmaceutical company to ensure that its suppliers meet the right standards, by sending teams of auditors on visits to the suppliers. In the absence of standards other than the industry's own GMP (good manufacturing practice), the results have often been inconsistent. Hence many companies are turning to the pharmaceutical auditor/lead auditor training to ensure the provision of properly skilled auditors who can successfully carry out structured and meaningful assessments.
For more information about the training course and early booking discounts, please contact the IQA training department by calling + 44 (0) 20 7245 6696 or visit the website at www.iqa.org/training. Copies of PS 9000 and PS 9100 can be purchased from IQA Information Services by calling + 44 (0) 20 7245 8511, alternatively order forms can be downloaded from the website www.iqa.org/information
Ends
Date of issue: 16 January 2003