IRCA GMP Lead Auditor (pharmaceutical quality systems) – PR325

5 Day/s

CPD Hours: 35

Classroom, online

IRCA CQI Accredited

This 5 day fully residential course, provides the most comprehensive training & certification for Auditors and Lead Auditor auditing GMP Pharmaceutical sites.


The course covers the role of an auditor to plan, conduct, report and follow up an audit of a pharmaceutical quality management system audit in accordance with ISO 19011. It gives you the skills to plan, conduct, report and follow up an audit of a pharmaceutical quality management system to establish conformance (or otherwise) against ICH Q10 and in accordance with ISO 19011. Learners will be assessed through practical tasks, activities and must also pass the IRCA  PR325 written examination that lasts 2 hours.

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This course is for those intending to acquire the knowledge and skills to audit a whole ICH Q10-based pharmaceutical quality management system, either as a third or second-party auditor. This course meets the training requirement for IRCA certification for all grades of PQMS Auditor.


PLEASE NOTE to comply with the IRCA certification rules, we are required to conduct an interview, prior to the course. It is just to check your background and past auditing experience etc. There is also a significant amount of course pre-work.

The course covers the following topics:


  • Day 1
    • Accreditation Structure and Auditor Competence
    • Types of Audits
    • Quality Concepts & Audit Relationships
    • Establishing an Audit Programme
    • Risk Analysis
    • Conducting an Audit
  • Day 2
    • Internal Audits
    • Why audit and audit frequency
    • What’s so Special About Pharmaceuticals?
    • Construction of Non-Conformities
    • Nonconformity Critique/ Reporting
    • Pharmaceutical Quality Systems and GMPs
    • Good Manufacturing Practice in the EU & UK Orange Guide
    • Good Manufacturing Practice in the USA & Rest of World
    • ICH Quality Standards (ICHQ8, Q9, Q10)
    • The Paper Audit
  • Day 3
    • Roles & Responsibilities
    • Conducting Opening Meetings
    • Personal Attributes & Active Listening
    • Questioning Techniques
    • Communication During Meetings
    • Conducting Closing Meeting
    • Audit Role Play
  • Day 4
    • Audit Role Play including, Opening Meeting, Conducting the Audit, Preparation for Closing Meeting and Closing Meeting
    • Effective Communication
    • Categorising audit findings and completing audit reports
    • Maintaining and Reviewing an Audit Programme
    • Preparation for the IRCA Lead Auditor Exam
    • Review of IRCA paper - selected questions
  • Day 5
    • Definition Revision
    • Non Conformity Reports
    • Review of IRCA specimen examination paper
    • Review of ISO Standards
    • IRCA Lead Auditor Exam

    By the end of the course you will:


    • Understand the ‘language’ of ISO 19011 and how it applies to auditing of suppliers
    • Understand how to apply the appropriate standards for auditing pharmaceutical suppliers
    • Plan, conduct, report and follow up an audit of a pharmaceutical supplier 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
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We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Peter Deegan

Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience.

Sue Mann

Sue has worked in the industry for over 38 years, principally in quality and technical roles. She has a wealth of experience having held European Director & VP level positions at companies such as Eisai and Shire. For the last 11 years, Sue has been an independent consultant providing services across all major dosage forms and more recently ATMPs.

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