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:
鈥nderstand the benefits of internal audits
鈥e able to initiate an audit
鈥ave the capacity to create a structured audit programme
鈥nderstand how to conduct an opening and a closing meeting
鈥e able to create a check list of questions to ask
鈥now how to write a non conformity report linked to a GMP change
鈥ppreciate the importance of reporting and follow up
鈥now 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:
鈥nderstand the benefits of internal audits
鈥e able to initiate an audit
鈥ave the capacity to create a structured audit programme
鈥nderstand how to conduct an opening and a closing meeting
鈥e able to create a check list of questions to ask
鈥now how to write a non conformity report linked to a GMP change
鈥ppreciate the importance of reporting and follow up
鈥now 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.
