Here is a free template for things that you should include in an auditing closing meeting.
- Thank the auditees for their time
- Thank them for allowing you to audit them
- Remind the auditees of the reason for the audit
- Remind the auditees of the standard that you audited against
- Remind everyone that the audit is confidential
- State that you have only looked at a sample of the system
- State if the audit is invalid (you may have needed to see a specific activity and you did not see this)
- Explain how you will present your findings
- Confirm any non-conformities and observations raised
- Provide a closing summary on how the audit has gone
- State your final conclusions of the audit (satisfactory, unsatisfactory, etc.)
- Tell the auditees when they will receive the audit report
- Tell the auditess what they are expected to do once they receive the report
- Allow any questions
I hope that this is of use when auditing. If you need any auditor training – please visit our web-site for details of our IRCA registered Pharmaceutical Quality Management Systems Auditor/ Lead Auditor training course. Previous feedback is below.
“Excellent” “superb” “Fantastic” “Wonderful” “A fantastic experience”
“Wow – brilliant” “A truly brilliant course” “A real joy working with you”
“Absolutely brilliant” “Recommended to anyone within the pharma industry”
“You both are the best tutors I have come across in my entire life”
Regards, Dominic
Here is a free template for things that you should include in an auditing opening meeting.
- Introduce your team
- State the reasons for the audit
- State the standard that you are auditing against
- Check if the programme is still OK
- Check who is available for the audit
- Confirm any logistics (rooms, lunch, guides, etc.)
- Remind auditees that the audit is confidential
- Check that any documents sent to you before the audit are still current
- State that you are only looking at a sample of the system
- Confirm how you will communicate findings during the audit
- Confirm time, location and attendees for the closing meeting
- Allow any questions
I hope that this is of use when auditing. If you need any auditor training – please visit our web-site for details of our IRCA registered Pharmaceutical Quality Management Systems Auditor/ Lead Auditor training course. Previous feedback is below.
“Excellent” “superb” “Fantastic” “Wonderful” “A fantastic experience”
“Wow – brilliant” “A truly brilliant course” “A real joy working with you”
“Absolutely brilliant” “Recommended to anyone within the pharma industry”
“You both are the best tutors I have come across in my entire life”
Regards, Dominic
A new update to EU GMP Chapter 2 has been issued and comes into operation on 16th February 2014. Here is a summary of the main changes from the previous version Chapter 2 Personnel OLD. A copy of the new version can be found by clicking on the link Chapter 2 Personnel NEW. Read more
On-line Qualified Person (QP) training has arrived to rave reviews.
Are you thinking of becoming a Qualified Person (QP)? Are you wishing to broaden your pharmaceutical experience and education? Do you not have the time to be away from home and the office?
The courses have been designed for busy QP candidates who want to fit short 15 to 30 minute chapters of learning into a hectic work schedule and cannot afford three, four or five days out of the office. Former delegates have also wanted to avoid “cramming” a vast amount of knowledge into a small window of time, preferring to spread their learning over a longer period, depending on their personal and business circumstances.
See this introductory video on our QP Quality Management Systems Programme:
I have been working with two multinational pharmaceutical companies recently and both have Corporate GMP requirements that all personnel have a copy of their Curriculum Vitae (CV), or résumé (if you are on the other side of the Atlantic), in individual’s training records. This at first seems a reasonable and simple requirement to implement – but I have seen a number of problems and a solution that may be of interest.
Read more
Inspired Pharma Blog 