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…
GXP / GMP Consultancy
Global projects successfully undertaken for some of the largest Pharma businesses
Online GMP and GDP Induction / Refresher training
A series of 15 to 30 minute online GMP and GDP training modules used either as part of an induction programme or as part of on-going refresher/compliance training for existing personnel.
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
GXP / GMP Consultancy
Global projects successfully undertaken for some of the largest Pharma businesses
Online GMP and GDP Induction / Refresher training
A series of 15 to 30 minute online GMP and GDP training modules used either as part of an induction programme or as part of on-going refresher/compliance training for existing personnel.
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
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.
Problems and deviations – avoid blaming the operator
You should be careful of putting “human error” as the cause of a problem, without considering what caused the human to make the error in the first place
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
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.
