Pharmaceutical Auditor/Lead Auditor (Course Reference: A17129)

New!  Now incorporating the latest guidance on primary packaging materials (ISO 15378), components for Orally Inhaled and Nasal Drug Products (IPAC-RS) and the Joint IPEC/PQG Excipient Guide.

£2350 + VAT

19th -23rd May 2008

15th - 19th September 2008

3rd - 7th November 2008

This IRCA certified 5 day intensive residential course is the ultimate course for pharmaceutical auditors.

The course has had continuous accreditation since its establishment in 1999 and has a very high success rate. It deals with the requirements of the ISO 9000:2000 series and the Pharmaceutical Quality Group's application standards for suppliers to the pharmaceutical industry (PS9000 for Packaging Materials and PS9100 for Excipients)

The course is aimed at QA, QC and purchasing professionals from pharmaceutical companies, suppliers and third party certification bodies.

The course is also highly recommended for Qualified Persons as part of their Continuous Professional Development.

Course Content:

• Quality Management Systems
• Modern thoughts on quality
• The ISO 9000:2000 series of standards
• Auditor and lead auditor skills and competencies
• A process approach to auditing
• Planning, running, reporting and closing down audits
• Checklist construction
• Managing auditing teams
• GMP requirements for starting and packaging materials
• PS 9000:2001 for packaging materials
• PS 9100:2002 for excipients

To book a training course, please download the booking form, complete and email to bookings@rssl.com