QMS Lead Auditor for the Pharmaceutical Supply Chain CQI and IRCA Accredited (PR330)

5 Day/s

CPD Hours: 40

Classroom, Online, Blended, In-house

IRCA CQI accredited

Do you audit a diverse pharmaceutical supply chain? Whether it’s for packaging suppliers, starting materials suppliers, excipient, API suppliers this unique Lead Auditor course will arm you with the ability to plan and conduct supply chain audits with improved skill and confidence and know how to correctly assess conformance to the correct standards.

Please note - if the course date is listed as Blended (online and classroom), the first 2 days are run online, there is then a weeks break (for study) and then the final 3 days are run at the stated hotel, in the classroom

This is the only IRCA and PQG accredited course of its kind that delivers a tailored auditing course to supply-chain auditors, arming them with the knowledge and skills to audit in a diverse set of industries that supply products and materials to the pharmaceutical industry. Such suppliers often have a technical boundary between their industry standards and GMP; this course helps the auditor manage that boundary to achieve clear conformance assessment, using ISO9001 and PQG pharmaceutical supplier standards as the auditing reference standards.

We are proud to have trained hundreds of auditors from across the world. With a pass rate over 90% (the IRCA average is 76%), our tutors are world-class auditors in their field, who are passionate about transferring their skills to the next generation of auditors.

Our Lead Auditor courses are IRCA accredited, flexible and tailored to industry needs. We offer a wide range of delivery options, including face-to-face (residential), online via instructor-led blended learning or in-house through tailored programmes for the whole team. To maintain the quality and attention one would expect of our training, course attendee numbers are limited to 12.

What's included in the cost?

  • Course and supporting materials (available in digital or hardcopy form)
  • Course attendance certificate
  • Accommodation and all catering (this is unique to RSSL)
  • Full access to our expert tutor’s support during course times
  • Examination fees
  • Free 1-2-1 feedback session (on day 5)

CQI IRCA Certified Course Logo PQG
This course is for individuals intending to acquire the knowledge and skills to lead audits of suppliers utilising ISO9001, PS9000, EXCiPACT, ISO15378, IPEC and ICHQ7. Knowledge of these standards is desirable prior to the course, however, if you are new to them, we have designed pre-course work to bring you up to the required level. Delegates should have some knowledge of quality management systems, the QMS core elements and also the quality management principles.

Course pre-requisites

To comply with the IRCA certification rules, a tutor will conduct a short interview, prior to the course attendance. This will help you understand the level of participation expected during the course, pre-reading and pre-course preparation, plus discuss your personal learning objectives so we can meet your needs. RSSL prides itself on providing a safe and nurturing learning environment for all delegates; we are specially trained to provide an effective learning environment for persons with neurodiversity.

Course assessment

Delegates are assessed throughout the the course, including the PQG Packaging standards examination and concluding with an examination set by IRCA. Successful course participation and passing the IRCA examination will allow you to apply for IRCA Lead Auditor registration

The course covers the following topics for either face to face or virtual instructor led training (VILT) methods. All sessions include practical exercises, real world case-studies or audits with proven highly participative learning techniques.

Day 1

  • Accreditation structure and auditor competence
  • The principles of auditing
  • Establishing an audit programme
  • Risk analysis
  • Conducting an audit

Day 2

  • Conducting internal audits and self-inspections
  • Construction of non-conformities
  • Writing effective non-conformances
  • Guidelines for suppliers to the pharmaceutical industry
  • Change control and supplier management
  • Audit role play

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, communicating non-conformances
  • Effective communication
  • Categorising audit findings and completing audit reports
  • Maintaining and reviewing an audit programme

Day 5

  • Definitions revision (ISO9001)
  • Non-conformity reporting further exercises
  • Review of ISO 19011, ISO9001 standards
  • Individual tutor feedback to help with development planning
  • IRCA Lead Auditor exam

    By the end of the course you will:

    • Understand the ISO 19011 ‘Principles of Auditing’ and how it applies to both internal and outsourced auditing environments
    • 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:

    • Plan, conduct, report and follow up an audit according to the audit cycle of ISO 19011
    • Create a structured audit programme
    • Conduct an opening and closing meeting
    • Create a checklist of questions to ask
    • Write clear, concise non-conformity reports
    • Appreciate the importance of reporting and follow up
    • Know how to behave to avoid conflict and gain auditee acceptance
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Bring this course in-house

Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

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 run her own consultancy since 2009 and works with companies all around the world. She became a QP in the mid 1980’s and a QP Assessor in the early 2000’s. Although her core knowledge and experience is in GMP, she has built up knowledge and experience in Good Distribution Practice (GDP) and has helped write a guidance document published by PQG and ECA which expands upon the EU GDP Guideline. Sue has dealt with many GMP systems in her over 40 years’ experience in the industry; including WHO whilst involved in a development project in a number of African countries, funded by UNIDO. Sue has been a QP for many years and understands the complexity of the role and its position within a company. She is an inspiring trainer being able to break down complex topics into understandable sections and can “train” at all levels in an organisation. She understands what it is that is important in fulfilling the role of a QP.

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