QMS Lead Auditor for the Pharmaceutical Industry (PR330)
This is the only IRCA and PQG accredited course of its kind, delivering a tailored auditing course to supply-chain auditors, providing the knowledge and skills to audit across a diverse range 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.
Both 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 (unique to RSSL)
- Full access to our expert tutor’s support during course times
- Examination fees
- Free 1-2-1 feedback session (on day five)
Interested in QMS Lead Auditor training for your team? Contact us today.
This course is designed for those looking 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 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.
Delegates are assessed throughout 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.
Key topics
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.
Accreditation structure and auditor competence
The principles of auditing
Establishing an audit programme
Risk analysis
Conducting an audit
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
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
With over 50 years of combined experience our Lead Auditor experts have trained hundreds of delegates to lead audits with confidence and success.
If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.
Yes, the QMS Lead Auditor for the Pharmaceutical Supply Chain course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details.
Places will be available for you to book unless it states ‘Full’ next to your chosen QMS Lead Auditor for the Pharmaceutical Supply Chain course date. When this occurs, we operate a waiting list service.
Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems.
You will need to first register yourself on our booking system by selecting the QMS Lead Auditor for the Pharmaceutical Supply Chain course date that you wish to book your colleagues onto, then:
- Add the number of people you wish to book onto the course
- Register yourself as the booker and complete the fields accordingly
- Add the details of those you wish to book for
- Complete your order.
You will receive an automated email confirming your booking details for the QMS Lead Auditor for the Pharmaceutical Supply Chain course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included.
Usually, this 5-day QMS Lead Auditor for the Pharmaceutical Supply Chain course is delivered live by our tutor, virtually on the Adobe Connect training platform. If you are looking for in-person training only, please get in touch with the team to discuss your needs via trainingsales@rssl.com or +44 (0)118 918 4000.
Our online QMS Lead Auditor for the Pharmaceutical Supply Chain course begins at 09:00am, although we request that you login at 08:30am to ensure any technical glitches can be resolved before the start time. Please review your course confirmation email to double check the exact start time of your specific course.
For our in-person courses, refreshments are available from 08.30am, for a 09:00am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later. If you need an exact finishing time to allow for travel arrangements, please contact us via trainingsales@rssl.com or +44 (0)118 918 4000.
Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system.
Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you.
Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address.
Yes, certificates of attendance are issued after we have received payment in full for the course. If you have not received your certificate, please contact your own finance department to confirm if they have sent payment to us. All certificates are issued electronically by email.
As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to visit the download webpage.
Please see our 'minimum requirements' document for further details on what you'll need to attend our virtual courses. You can test that the Adobe Connect application works for your organisation by completing the RSSL Adobe Connect Function Test.
Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees.
All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK.
Our classroom courses are fully catered, and we provide all refreshments. If you have any special dietary requirements, please enter these into the ‘dietary requirements’ field when creating your account. Our virtual tutor-led courses will include a 45-minute lunch break.
Find out what our former alumni have thought about our Lead Auditor course below
We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
At the end of this 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
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
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
