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?

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Inspired Pharma 2017 course dates

2017 course dates

Our public course dates for 2017 are now available

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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

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GDP on-line 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.

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QP Training Study anytime anywhere

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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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”

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QMS courses

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

Read More

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

2017 course dates

Our public course dates for 2017 are now available

Read More

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

Read More

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.

Read More

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…

Read More

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”

Read More

HOW WE CAN HELP YOU:

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:

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

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

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.

Forthcoming Public courses

May
09 Data Integrity
10 Internal Auditor
15 Pharma GMP Lead Auditor
23 Problem Solving
25 Good Distribution Practice

June
07 Good Manufacturing Practice
26 Pharma GMP Lead Auditor, Dublin

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

Online QP training

Access Online Learning

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