Inhalation drug product testing
Back to School - 15% Discount Offer
Available on all 2022 courses (except QP, RP and IRCA) booked by 31st October 2022
Diversity & Inclusion
CPD Hours: 40
IRCA CQI accredited
This 5 day fully residential course provides the most comprehensive certification for Lead Auditors to the supply chain in the Pharmaceutical industry. Fully accredited by IRCA and PQG, this is a highly customised Lead Auditor training course that provides the delegate with a qualification in auditing that is recognised by the International Register of Certified Auditors(IRCA) to ISO9001 Quality Management Systems and The Pharmaceutical Quality Group (PQG) PS9000 Pharmaceutical Supplier Standards.
This course is founded on the audit principles defined in ISO19011:2018, and supporting ISO standards, and provides an excellent structure on which to introduce, develop or monitor both internal and external audit processes. PR330 incorporates the principles of performing 1st, 2nd and 3rd party audits as a Lead Auditor to the supply chain of pharmaceutical manufacture. This course is intended for individuals to acquire the knowledge and skills to lead audits of suppliers utilising ISO9001, PS9000, ISO9001, EXCiPACT, ISO15378, and IPEC. The regulatory background for medicinal products and an overview of the standard content is discussed. Exercises are also included for ICHQ7 for active pharmaceutical ingredients however this does not form part of the examination process detailed below.
Knowledge of ISO9001, ISO15378, PS9000, IPEC and EXCiPACT standards is desirable prior to the course however, just in case you are new to them, we have designed pre-course work to help you. During the course, our tutors will take you through each stage of the audit process, and provide you with experience of applying different standards in an audit situation, with a final full audit process using ISO9001.
It is also desirable you have some knowledge in the following areas: Quality Management systems and the core elements of a management system and the interrelationship between top management responsibility, policy, objectives,planning, implementation, measurement, review and continuous improvement, The quality management principles (see ISO 9000) are also desirable and the relationship between quality management and customer satisfaction and also ISO9001.
By the end of the course you will:
And be able to:
We offer a number of discounts and specials offers on our training courses including Early-bird, Group booking, NHS and Seasonal discounts.
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 is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience.
Sue has worked in the industry for over 38 years, principally in quality and technical roles. She has a wealth of experience having held European Director & VP level positions at companies such as Eisai and Shire. For the last 11 years, Sue has been an independent consultant providing services across all major dosage forms and more recently ATMPs.
GMP pharmaceutical quality system auditor / lead auditor
This 5 day fully residential course, provides the most comprehensive training & certification for Auditors and Lead Auditor auditing GMP Pharmaceutical sites.