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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) and the Pharmaceutical Quality Group (PQG).

Frequent opportunities are provided to check knowledge acquired before the staged formal assessments, and delegates are supported by regular constructive feedback. This 5 day residential course is focused on providing you with the knowledge and skills required to perform first, second and third-party audits of quality management systems, against ISO 9001 and the specific GMP standards that have been developed for the supply of packaging, excipient and Active Pharmaceutical Ingredient (API) materials to the pharmaceutical industry. ISO 9001 is covered in detail and this will enable pharmaceutical auditors to converse in the language that is universally used by its suppliers.

On successful completion of this course, delegates may apply for professional recognition as an IRCA certified QMS Lead Auditor and PQG Accredited Course.

SUITABILITY

This course is 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. Before starting this course, it is expected that delegates have prior knowledge in the following areas: Management systems (The Plan, Do , Check, Act (PDCA) cycle, the core elements of a management system and the interrelationship between top management responsibility, policy, objectives,planning, implementation, measurement, review and continuous improvement), Quality management (The fundamental concepts and the seven quality management principles (see ISO 9000) and the relationship between quality management and customer satisfaction) and finally ISO9001, (Knowledge of the requirements of ISO 9001 and the commonly used quality management terms and definitions, as given in ISO9000). Whilst the course builds on these concepts, a foundation level of understanding is essential for maximum engagement in sessions.

LEARNING OUTCOMES

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