J E M O Limited
Copyright © J E M O Ltd 2015, All Rights Reserved
J E M O Ltd Registered in England & Wales Reg. no 4933247
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[1] Q: Do I become a registered auditor or lead auditor as soon as I pass the course?
Answer:
No – it is a 2-stage process. First you obtain the training – that is what this course is for. Then you have to do some auditing to an acceptable standard and submit evidence of this. We will explain all of this and show you the documents you have to complete. Then you apply to IRCA or RABQSA and they process your application.
 

 

Do I become a registered auditor or lead auditor as soon as I pass the course?
What are IRCA and RABSQA?
Will the audits I have done before the course count?
What are the benefits of being IRCA or RABSQA registered?

What are the PS 9000 standards?

What is the regulator’s position on these standards?

What is ISO 15378?

[2] What are IRCA and RABSQA?

Answer: They are the major registrars for management system auditors and lead auditors. IRCA is based in London and RABQSA is based in United States, Australia and Korea. They mutually accept each other’s course certificates so that you can apply by either route.

[3] Q: Will the audits I have done before the course count?

Answer: Unfortunately they will not. You have 3 years from completing the course in which to obtain the audit experience. In general this is not more than 25 days of auditing time including off-site preparation and auditing.

[4] Q: What are the benefits of being IRCA or RABSQA registered?

Answer: The benefits are significant. Firstly you obtain professional recognition of your management auditing skills. Secondly it is a very significant addition to your Resume. Thirdly your organisation can demonstrate to regulators and customers that they have professional auditors involved in the supply chain risk reduction process. You will also have a much better knowledge of how external auditors operate and how to respond to them. You can pass this knowledge onto your colleagues using the comprehensive course notes.

[5] Q: There is an assessment of me during the course – what does this involve?

Answer: The assessment is in two stages – a continuous assessment of your performance in the various exercises and a written examination. This is a requirement of IRCA and RABSQA. The assessment is carried out by the tutors against rules set by the regulators. A primary role for the tutors is to identify at the early stages, people who may have problems understanding what is being taught. We can, and do, provide private tuition after the course official finish times to give these people the best chance of passing.

The 2-hour written exam is selected from a number set by the regulators and are taken open-book which means you can have all the standards, personal notes and the very comprehensive course reference book available during the exam. We also provide plenty of exam practice during the course.

[6] Q: What are the PS 9000 standards?

Answer: These are standards produced by the Pharmaceutical Quality Group (PQG) which is a specialist group from the Chartered Quality Institute (CQI) based in London.

The two main standards are PS 9000 which applies good manufacturing practices to pharmaceutical packaging and printed components such as labels and patient information leaflets (PIL) and PS 9100 which does the same for excipients. PS 9100 at the highest level of GMP is equivalent to ICH Q7.

There are also a number of specialist guides including a very good guide to implementing PS 9000 using a risk based approach and another for supply chain risk management.

Why not visit www.pqg.org for the full list of publications.

We supply many of these for use on the course and also have full audit checklists for PS 9000 and PS 9100.

There is an assessment of me during the course – what does this involve?
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Can a company be certified to any of these standards?

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Auditor Training, Assessment & Consultancy
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