Auditing to Pharmaceutical Standards

Essential Training on Quality Audits and Relevant Standards

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).

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Duration
1 day
CPD Hours
7 hrs
Locations
  • Online

Who Should Attend

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.

 

  • A core auditor competence is to know the requirements of the QMS/system you are auditing and be able to set accurate audit criteria, against which you can assess conformance.
  • 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.

 

 

Course pre-requisites

 

GMP knowledge - participants are expected to have a working knowledge of Basic GMP requirements prior to attending this course.

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Key topics

The course covers the following topics: 

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    EU Guide to GMP and supplier requirements API GMP and ISO9001

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    Excipients 

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    Packaging: PS9000 and ISO 15378 

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    ISO 17025 (Contract Testing) 

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    Good Distribution Practice (GDP) 

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    Medical Devices ISO13485 

Learning Outcomes

By completing this course,  you will be able to construct clear audit criteria when planning and conducting an audit against the following guidance's 

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    EU GMP Part I - Basic Requirements for Medicinal Products 

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    EU GMP Part II - Basic Requirements for Active Substances used as Starting Materials 

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    EU GMP Part III - ICH Q9, ICH Q10, ISO 9001 - Quality Management Systems 

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    PS 9000 - Application standard for Good Manufacturing Practice relating to the manufacture of packaging materials for medicinal products

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    EXCiPACT and IPEC/PQG GMP guide for pharmaceutical excipients 

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    ISO 17025 - competence of testing and calibration laboratories 

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    ISO 13485 - Quality management systems for Medical Devices 

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    ISO 15378 - Primary Packaging Materials 

Meet your expert tutors

Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you. 

Peter Deegan (1)

Peter Deegan

Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience. Peter is adept at working with a cross-slice of people to drive a positive ‘Quality Culture’, from shopfloor to boardroom and is passionate about passing on his personal experience to others, through education, coaching, mentoring and training.
Frequently asked questions

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.

What our clients say

Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development. 

Passionate tutor makes learning engaging and enjoyable

The tutor obviously cared about his subject area and that passion can be passed on to others to perform as best as they can. It helps to make the session more interesting and enjoyable.
Ayesha Bottle
Jazz Pharmaceuticals Research Limited - Senior Scientist, Quality Control

Highly relevant content

Very good. Peter's expertise were obvious and he was able to articulate this over to the team, which is a skill in its own right. Highly relevant content which I feel was a good stepping stone to further Quality training.
David Leslie
SGS Quay Pharmaceuticals Limited - Head of Quality Assurance

Auditing expectations made clear

There was a lot of information covered which gave me a greater understanding of what is expected of me, not only as a potential auditor, but also when 'we' are being audited. Peter is obviously very experienced and knowledgeable on the subject matter, which he expanded upon with ease.
Matt Mason
SGS Quay Pharmaceuticals Limited - Laboratory Validation Officer

The course leader was engaging and easy to listen to

The course leader was engaging and easy to listen to. A good introduction to the subject matter.
Victoria Willoughby
SGS Quay Pharmaceuticals Limited - Quality Compliance Officer

The course made think differently about how to audit - for example, during a recent external audit, I was looking out for whether the set guidelines in the Orange Guide were complied with. Now I will approach audits with the mindset of what we require and whether their current quality systems and processes meet our needs.
Anonymous
Multinational Testing and Certification Company - Senior QA Officer

Book Your Place

Auditing to Pharmaceutical Standards
19 Nov 2025
-
Online
£820 excl VAT
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Bespoke Training

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.

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Special Offers

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

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Further courses to consider

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Focused on GMP, this training provides the skills to plan and conduct audits with confidence.


£1640 ex VAT
Virtual tutor-led
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Why choose RSSL?

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.

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    More than 30 years of experience upskilling pharmaceutical professionals

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    Small-group training adjusted to individual learning styles and needs

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    50+ training courses accredited by recognised industry bodies

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    Combination of off-the-shelf and bespoke training packages

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    Courses and consulting led by experts in the entire pharmaceutical life cycle

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    Opportunity to share and learn as part of a diverse community