Audience

Suitable for people who have been doing some auditing already – perhaps internal auditing and/or supported external audits – and have now been asked to take the lead in external supplier audits.

Duration

5 days

Objectives

By the end of the course you will:
• Appreciate the commercial benefits of such audits
• Understand the ‘language’ of ISO 9001 and how it applies to auditing of suppliers
• Understand how to apply the appropriate standards for auditing pharmaceutical suppliers:
- PS9000 for packaging components
- EXCiPACT and IPEC/PQG GMP for Excipients
- EU GMP Part II for APIs,ISO 15378 for primary packaging components

And be able to:
• Initiate an audit according to ISO 19011
• 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

Content

This course is founded on the audit principles defined in ISO19011:2018, and supporting ISO standards, and provides an excellent structure on which to introduce, develop or monitor both internal and external audit processes.

Risked based thinking is a key element though out the course and helps with the development of an audit programme and audit plan which supports the context of the organisation.

In addition, the course provides an audit process, structure and further working practice as Audit Lead using standards such as ISO9001, ISO15378, PS9000, IPEC, EXCiPACT.

Please note: This is a fully residential course run at the prestigious CIM Moor Hall Conference Centre, Cookham, Maidenhead, Berkshire, SL6 9QH. The course fee includes 4 nights’ accommodation and includes; breakfast, lunch and an evening meal.

Cost

Non-Member - £2995 + VAT
One Nucleus Member* – £2396 +VAT

*Please email training@onenucleus.com for the ON member discount code.

Training provided by

Tel: 0118 918 4076
Email: bookings@rssl.com