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.
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.
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
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.
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.
Hot off the press – find out more about new guidance from the MHRA on GMP data integrity expectations for the pharmaceutical industry.
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).
Interactive and thought provoking classroom and online GDP and GMP training courses facilitated and developed by Pharma experts with great training abilities
Global projects successfully undertaken for some of the largest Pharma businesses
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.
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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