Designed for Auditors in the Pharmaceutical Industry (IRCA Ref No A17129)
Location - The Randolph Hotel, Oxford, UK
Dates - 14th - 18th May 2012, 22nd - 26th October 2012
Price - £2250 + VAT
What recent delegates have said about the course:
"Experienced tutors, with a gift for teaching, providing comprehensive, sensibly paced training that can really make a difference, not just in the classroom, but in the audit room" (Feb 2009)
"Best course I have ever attended, with the best tutors, too. I can't believe how much [they] managed to fit into 4.5 days and still make the course interesting and fun" (Feb 2009)
Scope
Successful completion of this course provides the delegate with a qualification in Auditing that is recognised by the International Register of Certified Auditors (IRCA - Ref No A17129) and the Pharmaceutical Quality Group.
Frequent opportunities are provided to check knowledge acquired before the staged formal assessments, and delegates are supported by regular constructive feedback.
The course is focused on ISO9001 and the specific GMP standards that have been developed for the supply of packaging and excipient materials to the pharmaceutical industry. ISO9001 is covered in detail and this will enable pharmaceutical auditors to converse in the language that is universally used by its suppliers.
Suitability
The course is suitable for people who have been doing some auditing already (perhaps internal auditing and/or supported external audits) and who have now been asked to take the lead in external supplier audits.
It is also highly recommended for Qualified Persons as part of their continuous personal development.
Knowledge and Skills
By the end of the course you will be able to:
- Understand the regulatory framework for supplier audits
- Appreciate the commercial benefits of such audits
- Understand the 'language' of ISO9001
- Be familiar with the supplier GMP standards PS9000, PS9100, ISO15378, IPAC-RS, PCEG and IPEC
- Initiate an audit according to ISO19011
- Create a structured audit programme
- Conduct an opening and closing meeting
- Create a checklist of questions to ask
- Write non-conformity reports
- Appreciate the importance of reporting and follow-up
- Know how to behave to avoid conflict and gain audience acceptance
Tutors
Aidan Madden and Ashley McCraight (current Chairman of Pharmaceutical Quality Group)
The course fee includes lunch and refreshments throughout, and a walking tour of Oxford, but is exclusive of overnight accommodation charges; we have negotiated substantial discounted rates with the venue and will book your accommodation for you, but you will need to settle your own account upon departure.
To book a training course, please download the booking form
, complete and email to bookings@rssl.com