GMP Lead Auditor (PQS) CQI and IRCA Accredited (PR325)

5 Day/s

CPD Hours: 40

Classroom, online, in-house

IRCA CQI Accredited

Do you audit your GMP environment, either self-inspections or outsourced providers? Are you armed with the tools required to carry out audits to the latest guidelines? This course provides the essential skills to plan and conduct audits with improved ability and confidence, ensuring you know how to correctly assess conformance to the correct GMP and ICH Quality guidelines.

Fully accredited by IRCA, our GMP PQS Lead Auditor (PR325) course covers the whole audit cycle, from setting the annual audit programme, through to planning, conducting, reporting and follow-up of audits to cGMPs, ICHQ10, API and excipient standards and guidelines. Delegates will be assessed through practical tasks, using real world case studies and mock audits covering internal audits and self-inspections, external outsourced GMP supplier audits and a range of dosage forms.

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 course cost?
  • Course and supporting materials (available in digital or hardcopy)
  • 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)

Hear what our recent delegates said:

CQI IRCA Certified Course Logo
This course is for those individuals intending to acquire the knowledge and skills to audit a GMP Pharmaceutical Quality System, including ICHQ10. It will enable you to conduct effective self-inspection internal audit and external audit programmes that will significantly contribute to your GMP-assurance obligations. Delegates should have a good working knowledge of GMP with ideally 3-5 years experience working in a GMP environment prior to attending the course.

RSSL prides itself on providing a safe and nurturing learning environment for all delegates; we are also specially trained to provide an effective learning environment for neurodivergent people.

Course pre-requisites

To comply with the IRCA certification rules, a tutor will conduct a short interview, prior to 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.

Course assessment
Delegates are assessed throughout the course, 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, giving your CV and profile a step-up within the industry. In the unlikely event you do not pass, RSSL will continue to support you and you will be able to re-sit the examination at the next available date.

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 and audits with highly participative proven learning techniques.

Day 1

  • Accreditation structure and auditor competence
  • Types of audits
  • 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
  • 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)
  • Audit role play

Day 3

  • 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
  • Non-conformity reporting further exercises
  • Review of ISO 19011 and GMP 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
    • Understand how to apply the appropriate GMP standards for auditing to internal self-inspections or pharmaceutical suppliers
    • 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

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.

Adam Slater

Adam is an experienced Pharmaceutical/Biopharmaceutical QA professional, with over 35 years GMP, GDP, ISO 9001, Pharmaceutical Quality Systems, and audit experience. Adam is a Microbiology and Chemistry Graduate and started his career in QC laboratories within the NHS, before moving into private industry. He then moved into QC and QA roles within different contract manufacturing companies. In 2004 he joined Wyeth (now Pfizer). He also completed his EU Qualified Person training during this time and within Wyeth led a team responsible for contract manufacturing operations in Europe, Middle East, and Africa. He has held positions in QC, QA, Regulatory, R&D, Operations, Technical Support and Validation. He has a wide experience of dosage forms and specialises in Sterile Manufacturing and US FDA PAI readiness and remediation. Adam established his own consultancy in July 2010. He is an active, highly experienced international auditor and has worked extensively in India, China, Pakistan, Middle East, Japan, and the USA. Adam has worked with a wide range of personnel and across many countries. He has also held senior leadership and board roles and throughout his career he has promoted a positive ‘Quality Culture’. He is passionate about passing on his personal experience to others, through education, coaching, mentoring, and training.

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