QMS Lead Auditor for the pharmaceutical supply chain (PS9000/ISO9001) – IRCA PR330

5 Day/s

CPD Hours: 35


IRCA CQI accredited

This 5 day fully residential course, provides the most comprehensive certification for Lead Auditors to the supply chain in the Pharmaceutical industry. Fully accredited by IRCA and PQG, this is a highly customised Lead Auditor training course that provides the delegate with a qualification in auditing that is recognised by the International Register of Certified Auditors(IRCA) to ISO9001 Quality Management Systems and The Pharmaceutical Quality Group (PQG) PS9000 Pharmaceutical Supplier Standards. PLEASE NOTE - unlike some other training providers, we include all your hotel accommodation, breakfast and meals, in the price.

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. PR330 incorporates the principles of performing 1st, 2nd and 3rd party audits as a Lead Auditor to the supply chain of pharmaceutical manufacture. This course is intended for individuals to acquire the knowledge and skills to lead audits of suppliers utilising ISO9001, PS9000, ISO9001, EXCiPACT, ISO15378, and IPEC. The regulatory background for medicinal products and an overview of the standard content is discussed. Exercises are also included for ICHQ7 for active pharmaceutical ingredients however this does not form part of the examination process detailed below.

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This course is suitable for auditors who have experience of auditing – perhaps internal auditing and/or supported external audits – and have now been asked to take the lead in external supplier audits.

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.

Knowledge of  ISO9001, ISO15378, PS9000, IPEC and EXCiPACT standards is desirable prior to the course, however, just in case you are new to them, we have designed pre-course work to help you.  During the course, our tutors will take you through each stage of the audit process, and provide you with experience of applying different standards in an audit situation, with a final full audit process using ISO9001.

It is also desirable you have some knowledge in the following areas: Quality Management systems and the core elements of a management system and the interrelationship between top management responsibility, policy, objectives,planning, implementation, measurement, review and continuous improvement, The quality management principles (see ISO 9000) are also desirable and the relationship between quality management and customer satisfaction and also ISO9001.

The course covers the following topics:

  • Day 1
    • Accreditation structure and auditor competence
    • Types of audits
    • Quality concepts and 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
    • Guidelines for Suppliers to the pharmaceutical industry
    • The different standards
    • Change control and supplier management
    • Review of PQG pharmaceutical specimen exam paper
    • The paper audit
  • Day 3
    • PQG pharmaceutical exam
    • Roles and responsibilities
    • Conducting opening meetings
    • Personal attributes and 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 9001 standard
    • Review of ISO standards
    • IRCA lead auditor exam

    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
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Meet the tutors

David Abraham

With extensive knowledge of business operations and processes, manufacturing operations, logistics, printed packaging and pharmaceutical industry applications, David Abraham has worked in and alongside working parties at national and international level, developing guidance and standards for the industry. He has been instrumental in the development of the PS 9000 publications.

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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