QMS Lead Auditor for the Pharmaceutical Industry (PR330)

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 Hybrid (online and classroom), the first 2 days are run online, there is a few days in between (for study) then the final 3 days are run at Moor Hall in Cookham, 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)

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