Posts from the ‘Uncategorized’ Category
February 14, 2014
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”
November 20, 2013
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:
May 13, 2013
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
March 13, 2013
Good Distribution Practice, or GDP, is the standard used to cover the movement and transport of materials. Historically GDP covered the movement of finished product from the pharmaceutical manufacturing site to the wholesalers and retailers and strictly speaking this is still the case. However with ever more complicated movements of starting materials, intermediate products and finished products then the principles of GDP can apply throughout the whole supply chain – covering the movement of all materials both to and from a pharmaceutical manufacturing site. Read more
January 31, 2013
Just a reminder that the new EU GMP Chapter 1 on Pharmaceutical Quality Systems and Chapter 7 on Outsourced Acticities come into operation today (31st January 2013). To read my posts on these from last year and to see in actual text click on the links.
If you need any training support for auditing suppliers and pharmaceutical quality systems then visit our web-site for details of our IRCA registered Pharmaceutical Quality Management Systems Auditor/ Lead Auditor training course.