new EU GMP Directive

New EU GMP Directive published

The European Union has published its new Directive for pharmaceutical manufacturing sites that is to replace the existing Directive (Directive 2003/94/EC) for human medicines. From having an initial look at the new Directive, here are a few comments.

GMP Management review

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?

pharmaceutical training

2017 and 2018 course dates

Our public course dates for the rest of 2017 together with the 2018 dates.

on-line GMP course

Launch of short on-line GMP course

Now available – a 1-hour on-line course designed to introduce people new to the pharmaceutical industry to the main requirements of Good Manufacturing Practice with versions for Warehouse, Packaging and Manufacturing personnel

GDP online course

Launch of short on-line GDP course

This one-hour course is designed to provide people new to the pharmaceutical industry with an appreciation of the main requirements of Good Distribution Practice and/or for refresher/compliance training.

QP Training Study anytime anywhere

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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 whole days out of the office. Access using your pc, laptop, iPad…

PQMS Auditor/Lead Auditor Course

Pharmaceutical GMP Auditor/Lead Auditor Training

Europe’s leading and most successful IRCA registered Pharmaceutical Lead Auditor course – feedback includes “A fantastic experience”, “Wow – brilliant”, “Recommended to anyone within the Pharma industry”

New EU GMP Directive published

The European Union has published its new Directive for pharmaceutical manufacturing sites that is to replace the existing Directive (Directive 2003/94/EC) for human medicines. From having an initial look at the new Directive, here are a few comments.

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?

2017 and 2018 course dates

Our public course dates for the rest of 2017 together with the 2018 dates.

Launch of short on-line GMP course

Now available – a 1-hour on-line course designed to introduce people new to the pharmaceutical industry to the main requirements of Good Manufacturing Practice with versions for Warehouse, Packaging and Manufacturing personnel

Launch of short on-line GDP course

This one-hour course is designed to provide people new to the pharmaceutical industry with an appreciation of the main requirements of Good Distribution Practice and/or for refresher/compliance training.

Qualified Person – study anytime, anywhere

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 whole days out of the office. Access using your pc, laptop, iPad…

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Pharmaceutical GMP Auditor/Lead Auditor Training

Europe’s leading and most successful IRCA registered Pharmaceutical Lead Auditor course – feedback includes “A fantastic experience”, “Wow – brilliant”, “Recommended to anyone within the Pharma industry”

QMS Courses

We offer a range of highly interactive and modern thinking Quality Management related training courses aimed at individuals involved in creating, monitoring and evaluating pharmaceutical quality systems

GDP and GMP training courses

Interactive and thought provoking GXP and GMP training courses facilitated by Pharma experts with great training abilities

Qualified Person – study anytime, anywhere

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 whole days out of the office. Access using your pc, laptop, iPad…

Qualified Person – study anytime, anywhere

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 whole days out of the office. Access using your pc, laptop, iPad…

Pharmaceutical GMP Auditor/Lead Auditor Training

Europe’s leading and most successful IRCA registered Pharmaceutical Lead Auditor course – feedback includes “A fantastic experience”, “Wow – brilliant”, “Recommended to anyone within the Pharma industry”

QMS Courses

We offer a range of highly interactive and modern thinking Quality Management related training courses aimed at individuals involved in creating, monitoring and evaluating pharmaceutical quality systems

GDP and GMP training courses

Interactive and thought provoking GXP and GMP training courses facilitated by Pharma experts with great training abilities

RECENT ARTICLES ABOUT GMP:

New EU GMP Directive published

The European Union has published its new Directive for pharmaceutical manufacturing sites that is to replace the existing Directive (Directive 2003/94/EC) for human medicines. From having an initial look at the new Directive, here are a few comments.

Must, Shall and Should – the use of these words in GMP

What is the difference in meaning between these words in the context of GMP?, In this post I explain, using EU GMP as my point of reference, although as you will find out, there are occasions within EU GMP where the incorrect terms have been used.

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?

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.

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

New EU GMP Directive published

The European Union has published its new Directive for pharmaceutical manufacturing sites that is to replace the existing Directive (Directive 2003/94/EC) for human medicines. From having an initial look at the new Directive, here are a few comments.

Must, Shall and Should – the use of these words in GMP

What is the difference in meaning between these words in the context of GMP?, In this post I explain, using EU GMP as my point of reference, although as you will find out, there are occasions within EU GMP where the incorrect terms have been used.

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?

Forthcoming Public courses

October
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
23 Data Integrity

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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

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