Course Scope
This modified course focuses on auditing to the ISO 9001 standard and the Pharmaceutical Quality Group's (PQG’s) Application Standards for suppliers to the pharmaceutical industry. Successful completion of this course provides the delegate with a qualification in auditing that is recognised by the International Register of Certified Auditors (IRCA) and the PQG.
Frequent opportunities are provided to check knowledge acquired before the staged formal assessments and delegates are supported by regular constructive feedback.
This 5 day residential course is focused on providing you with the knowledge and skills required to perform first, second and third-party audits of quality management systems, against ISO 9001 and the specific GMP standards that have been developed for the supply of packaging, excipient and active pharmaceutical ingredient (API) materials to the pharmaceutical industry.
ISO 9001 is covered in detail and this will enable pharmaceutical auditors to converse in the language that is universally used by its suppliers.
On successful completion of this course, delegates may apply for professional recognition as an IRCA certified QMS Lead Auditor and PQG Accredited Course.
This course is suitable for people who have been doing some auditing already — perhaps internal auditing and/or supported external audits — and have now been asked to take the lead in external supplier audits.
Before starting this course, it is expected that delegates have prior knowledge of the requirements of ISO 9001, and quality management principles and concepts. Whilst the course builds on these concepts, a foundation level of understanding is essential for maximum engagement in sessions.
Suitability
This course is suitable for people who have been doing some auditing already — perhaps internal auditing and/or supported external audits — and have now been asked to take the lead in external supplier audits.
Before starting this course, it is expected that delegates have prior knowledge of the requirements of ISO 9001, and quality management principles and concepts. Whilst the course builds on these concepts, a foundation level of understanding is essential for maximum engagement in sessions.
Learning Outcomes
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, including the following:
- 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.
About 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 Cormack
Peter Cormack has worked in the pharmaceutical industry in QA, QC and technical support roles for more than 30 years. He has experience in a range of dosage forms, has been a named QP for a large UK based manufacturing site and is a proficient lead auditor who provides QP services, consultancy and training to the pharmaceutical industry.
Gaynor Mollaney
With more than 30 years' experience as a quality professional in the pharmaceutical and medical devices sectors, Gaynor Mollaney has worked in a wide range of companies and roles. From analytical chemistry she moved into microbiological testing and later on to more senior roles as Quality Director (QA and QC responsibilities), and QP. She has been directly engaged with inspection authorities (MHRA, FDA CDER and FDA CDRH) and inspection bodies for ISO 13485 accreditation; she now as an independent consultant Gaynor is involved in QP certification, PQS improvements, auditing and training.
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