GDP & RP News and Articles
Read our articles on GDP and Responsible Person (RP) regulatory developments as well as news about our courses in this area. The 5 most recent articles are shown in the slider and the rest are shown below.
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
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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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New course on Data Integrity
This course has already run very successfully on an in-house basis for our clients who are increasingly concerned to ensure that they comply with the latest regulations from the EU and the FDA regarding the data integrity of their systems.
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MHRA publishes new GMP Data Integrity Guidance
Hot off the press – find out more about new guidance from the MHRA on GMP data integrity expectations for the pharmaceutical industry.
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The main differences between GDP and GMP
The European Union’s guidelines on Good Distribution Practice (GDP) were updated at the end of 2013. This post covers an overview of the main differences between GDP and Good Manufacturing Practice (GMP).
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GDP and GMP training courses
Interactive and thought provoking classroom and online GDP and GMP training courses facilitated and developed by Pharma experts with great training abilities
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GXP / GMP Consultancy
Global projects successfully undertaken for some of the largest Pharma businesses
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Curriculum Vitaes in Training Records
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.
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Update to the EU’s Good Distribution Practice guidelines
The European Union’s GDP guidelines were updated on the 7th March 2013. This article is a simplified overview of the new GDP guidelines and features an opportunity to download a copy of the full Guide.
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Non-conformity – not following a procedure
A common finding when auditing is discovering that the organisation or department that you are auditing is not following their own internal procedure or policy. This is a non-conformity, and should be raised as such. The problem is – what clause of the standard actually states that you should follow your procedures? On investigation this is not as easy to find as you might like to think!
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We help people in Pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
We offer a wide range of highly praised and respected classroom and online training courses and also provide our global pharma clients with consultancy support. Our classroom courses are available on a public schedule and also can be customised for inhouse delivery at a client site.
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Forthcoming Public Courses
June
13 Good Manufacturing Practice
24 Pharma GMP Lead Auditor Dublin, Ireland
July
All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.
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Good Distribution Practice (GDP)
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QP Medicinal Chemistry & Therapeutics module
QP Quality Management Systems module
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