Course Scope
This course provides an introduction to the requirements of internal auditing described in the international standard ISO 19011. Frequent opportunities to practise 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
Overview:
The course will be assessed and certified by RSSL in line with the requirements of its lead auditor course, which is certified by International Register of Certified Auditors (IRCA). At the end of the course you will:
•Understand the benefits of internal audits
•Be able to initiate an audit
•Have the capacity to create a structured audit programme
•Understand how to conduct an opening and a closing meeting
•Be able to create a check list of questions to ask
•Know how to 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
Who should attend:
The course is suitable for people who are about to start auditing or who may already undertake some auditing, but have not yet had any formal training.
This course provides an introduction to the requirements of internal auditing described in the international standard ISO 19011. Frequent opportunities to practise 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
Overview:
The course will be assessed and certified by RSSL in line with the requirements of its lead auditor course, which is certified by International Register of Certified Auditors (IRCA). At the end of the course you will:
•Understand the benefits of internal audits
•Be able to initiate an audit
•Have the capacity to create a structured audit programme
•Understand how to conduct an opening and a closing meeting
•Be able to create a check list of questions to ask
•Know how to 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
Who should attend:
The course is suitable for people who are about to start auditing or who may already undertake some auditing, but have not yet had any formal training.
