5/15/23, 7:00 PM ​Pharmaceutical GMP Auditor / Lead Auditor course | CQI | IRCA

IRCAジャパンはこちら | Click here to visit IRCA Japan website close 

Home > Training > ​

Pharmaceutical GMP Auditor / Lead Auditor course

Training

​Pharmaceutical GMP Auditor / Lead Auditor course

Share this content

   

Course code
PR325

Duration
40 hours (indicative)

Category
Auditing

Type
CQI and IRCA Certified Training

Level
Professional

Scheme(s)
Pharmaceutical
https://www.quality.org/training/Pharmaceutical-GMP-Auditor-Lead-Auditor-course 1/6
5/15/23, 7:00 PM ​Pharmaceutical GMP Auditor / Lead Auditor course | CQI | IRCA

This course teaches you the purpose of a pharmaceutical quality

management system, of pharmaceutical quality systems standards,
of management system audits in the supply chain.

It covers the role of an auditor to plan, conduct, report and follow up an audit of a
pharmaceutical quality management system audit in accordance with ISO 19011. It gives you
the skills to plan, conduct, report and follow up an audit of a pharmaceutical quality
management system to establish conformance (or otherwise) against ICH Q10 and in
accordance with ISO 19011.

This course includes a 2-hour written examination.

Who is it for?
This course is for those intending to acquire the knowledge and skills to audit a whole ICH
Q10-based pharmaceutical quality management system, either as a third or second-party
auditor. This course meets the training requirement for IRCA certification for all grades of
PQMS Auditor.

Recommended prior knowledge

Knowledge of the requirements of ICH Q10 (plus ICH Q8 and ICH Q9)

A basic knowledge of the requirements of the relevant GxP legislation and guidance for the
discipline in which they will audit, eg Eudralex Volume 4 or 21 CFR (pertaining to cGMPs).
GxP knowledge would typically be obtained by a four-day (30+ hours) training course or
two years' experience working in a GxP environment, or a combination of both

Find this course

Search our database of global Approved Training Partners to find this course in a
location near you.

https://www.quality.org/training/Pharmaceutical-GMP-Auditor-Lead-Auditor-course 2/6
5/15/23, 7:00 PM ​Pharmaceutical GMP Auditor / Lead Auditor course | CQI | IRCA

Click here

Tags

Auditor/Lead Auditor | Pharmaceutical

​Pharmaceutical GMP Auditor Conversion course

https://www.quality.org/training/Pharmaceutical-GMP-Auditor-Lead-Auditor-course 3/6
5/15/23, 7:00 PM ​Pharmaceutical GMP Auditor / Lead Auditor course | CQI | IRCA

​IRCA Pharmaceutical Quality Management Systems Certification Scheme

Approved Training Partners of CQI and IRCA Certified Training

https://www.quality.org/training/Pharmaceutical-GMP-Auditor-Lead-Auditor-course 4/6
5/15/23, 7:00 PM ​Pharmaceutical GMP Auditor / Lead Auditor course | CQI | IRCA

Find this course

Search our database of global Approved Training Partners for this course in a location
near you.

Search now

Take the training quiz

If your not sure which course or level is right for you, take the training quiz and find out.

Start the quiz

Quality jobs and careers support

We’ve replaced our old jobs board with a new careers hub, exclusively for members.
Search for roles, use CV and interview tools, learn from resources, and get advice to
progress your career.

Terms and conditions

Accessibility

Privacy

Cookies

About the CQI

Press

Contact us

Find an IRCA registered auditor

ATP Portal

https://www.quality.org/training/Pharmaceutical-GMP-Auditor-Lead-Auditor-course 5/6
5/15/23, 7:00 PM ​Pharmaceutical GMP Auditor / Lead Auditor course | CQI | IRCA

Incorporated by Royal Charter and registered as a charity number 259678 © 2023 the CQI. All Rights
Reserved. This website uses cookies.

CQI   

IRCA  

https://www.quality.org/training/Pharmaceutical-GMP-Auditor-Lead-Auditor-course 6/6