GMP Training Online
Good Manufacturing Practice Course
This course provides grounding in the principles of Good Manufacturing Practice – specifically related to the manufacture of Investigational Medicinal Products (Annex 13). Applying GMP to IMPs provides assurance that results of clinical trials are not compromised by inadequate safety, quality or efficacy arising from unsatisfactory manufacture of product. It has many other benefits, including ensuring results are comparable across different batches of Investigational Medicinal Products. For the process to work, personnel must have an adequate training in requirements specific to Investigational Medicinal Products. Expanded 2014 edition. The course is currently available in English, Bulgarian, German, Hungarian, Polish and Russian.
This course follows the guidance of Annex 13 of the European Commission's GMP guidelines - relating to Investigational Medicinal Products. Learners also receive 9 Continual Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.
This course was written by McCarthy Consultant Services Inc (Canadian specialists in regulatory work to support the global pharmaceutical, biotechnology, medical device, food, natural health products and cosmetic industries). You will also stay up to date with any legislative changes in GMP relating to IMPs as our training courses are constantly monitored, reviewed and updated.
1.1 Definition of IMP
1.2 How does Annex 13 affect me?
1.3 Why do we need Annex 13 when we already have GMP?
1.4 Application of Annex 13
2.1 The Sponsor
2.2 The Manufacturer and Packager
2.3 The Qualified Person
2.5 Receipt of IMP at the clinical trial site (Step 1 – Check the packaging)
2.6 Receipt of IMP at the clinical trial site (Step 2 – Check the labelling)
2.7 Receipt of IMP at the clinical trial site (Step 3 – Check the study or trial number)
2.8 Receipt of IMP at the clinical trial site (Step 4 – Check the expiry/use by date)
2.9 Receipt of IMP at the clinical trial site (Step 5 – Check the patient ID and dosage)
2.10 Receipt of IMP at the clinical trial site (Step 6 – Check the storage conditions)
2.11 Receipt of IMP at the clinical trial site (Step 7 – Check the batch certification & temperature and humidity results)
2.12 Receipt of IMP at the clinical trial site (Step 8 – Quarantine if not assured)
2.13 Storage of the IMP
2.15 Handling the subject in a clinical trial
2.16 End of the study
3.1 Handling complaints
4.1 Final conclusion