This course provides an introduction to the requirements of internal auditing described in the international standard ISO 19011. Frequent opportunities to practice key steps are provided through role play in a no risk environment, with supportive feedback provided throughout. The course is focused on pharmaceutical GMP and several subjects are explored in detail which helps build up knowledge and confidence in GMP.
The range of other standards appropriate to external auditing (e.g. GDP, ISO 9001) are described briefly but not explored in depth.
This course is suitable for people who are about to start auditing or who may already have undertaken some auditing, but have not yet had any formal training. It is also suitable for those who wish to refresh their skills.
By the end of the course you will be able to:
- Understand the benefits of internal audits
- Initiate an audit
- Create a structured audit programme
- Conduct an opening and a closing meeting
- Create a check list of questions to ask
- Write a non conformity report linked to a GMP change
- Appreciate the importance of reporting and follow up
- Know how to behave to avoid conflict and gain auditee acceptance of findings
Programme
- What are audits & why do them – what do the standards require (GXP)?
- Setting up and Managing a programme
- Initiating an audit
- EU Guides to GxP
- Audit Preparation: Doc review
- Preparing on site activities
- Checklists
- Auditing techniques & Auditor competencies
- The audit process
- Non Conformities
- Preparing Audit Reports
Includes a number of interactive activities
Comments