Management Review – who, what, where and when?

The idea of Management Review meetings has only been a formal GMP requirement for the past 5 years or so. In the many visits that I do to pharmaceutical manufacturing sites I see these done – but rarely done well, which is a real shame. So what are these GMP Management Review meetings, why do we have them, what should be discussed, who should attend and how often should we have them?

Read More

Standards to use when auditing suppliers

If you are working to Good Manufacturing Practice (GMP) then you will need to audit many of your suppliers. GMP does not really tell you what pharmaceutical supplier standards you should or could use when auditing your suppliers this post lists of all the key standards to use when auditing suppliers including links to all of the key documents and authorities.

Read More

EU GMP Chapter 9: Self-Inspection – time for an update?

In the past few years eight of the nine chapters of EU GMP have been updated. However, Chapter 9 has not been updated at all. This is strange as GMP’s stance on Quality Management System thinking has evolved a lot of the past few years, so surely the requirements for the number one mechanism that you have to evaluate this system should be updated too? Here are my thoughts

Read More

Data Integrity – why all the fuss?

The careful and secure control of data and records has become a hot topic at regulatory inspections recently. One reason for this is the increased use of computer systems to hold data in one form or another. Let me give you an example of how keeping data accessible can become problematic with a non-pharmaceutical example from my own childhood.

Read More
Loading

Forthcoming Public courses

September
11 Pharma GMP Lead Auditor
19 Good Manufacturing Practice
20 Documentation and Records

October
03 Good Distribution Practice
10 Data Integrity
17 Internal Auditor

November
06 Pharma GMP Lead Auditor
21 Sterile Products
28 Problem Solving
30 Good Manufacturing Practice

January 2018
15 Pharma GMP Lead Auditor

All courses held in Reading UK unless stated otherwise. Click on course name for full details.

On-line courses available anytime anywhere

Online Good Distribution Practice (GDP) training course

Online Good Manufacturing Practice (GMP) training course

Pharma Quality Management Systems module

QP Medicinal Chemistry & Therapeutics module

QP Quality Management Systems module

Each course typically consists of 10-20 minute chapters of content followed by a quiz based assessment. The QP courses feature tutor assessment too. The learning is accessed over the internet using desktop computers, laptops, tablets and even smartphones.

You can access any online learning courses you have already purchased by clicking here

Subscribe to Blog via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Join 328 other subscribers.

Online QP training

Access Online Learning

You can access any online learning courses you have purchased by clicking here