A 1-day course aimed at providing learners with knowledge and understanding of the typical audit standards and guidances within the pharmaceutical and allied industries, particularly for auditors who undertake supplier audits.
The course walks the learner through the typical standards with an ’auditor’s eye’, giving you the background and applicability to the standard/guidance and enabling you to plan your audits more effectively.
This course falls into Step 1 of the RSSL ‘Auditor Career Pathway’:
For delegates new to auditing, it gives you a working knowledge of the key standards and guidances prior to you attending an auditor training course (e.g Internal Auditor).
For experienced auditors at the ‘Professional’ stage of your auditor career path, or auditors taking the next step to certification via the IRCA Lead Auditor course, it gives a refresher of the diverse auditing standards you may encounter, especially when auditing pharmaceutical and allied suppliers.
The course describes the relevant standards that you can expect to audit against, covering EU GMP Parts I, II and III; PS 9000; ISO 17025; ISO 15378, ISO 13485 and several elements of ISO 9001 (Quality Management Systems).
Ideal for auditors and audit teams at the Foundation-Practitioner level of experience as the course explores the key standards that they may encounter when auditing.
Course pre-requisites
GMP knowledge - participants are expected to have a working knowledge of Basic GMP requirements prior to attending this course.
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.
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