Pre-Assessment
20 Minutes
Course Study
2 Hours
Final Assessment
20 Minutes
Good Distribution Practice for RPs and Management
Including: Change Control, Deviations, CAPA and Falsified Medicines
Avge Pass Rate: 93.2% | You will have two attempts to pass the final assessment.
The Responsible Person should have appropriate competence and experience as well as knowledge of and training in Good Distribution Practice. This course will provide the Responsible Person with the knowledge to perform their duties within a WDA site.
It is a requirement stated in the EU GDP Guidelines 2013/C 343/01 that Good Distribution Practice training is carried out on an annual basis to keep up to date with industry and regulatory changes. At the end of this course you will achieve a certificate of successful completion and evidence of your training for you records.
The learning objectives of this course are:
- Be able to demonstrate knowledge and understanding of RP duties and responsibilities.
- Understand GDP compliance requirements for Falsified Medicines, Deviations and Documentation.
- Understand in more detail the contents and requirements of EU GDP Guidelines 2013/C 343/01
- Be able to demonstrate competency in GDP through scenario based testing.
- Develop an awareness of (and knowledge of the differences between) falsified medicines and counterfeit medicines
You will also learn:
- The role of the MHRA and the IAG.
- Compliancy in Transportation.
- Compliancy in cold chain medicinal products.
- Good Self-inspection procedure.
- Application and engagement of the QMS.
- How to maintain and clean your premises to a compliant standard.
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Ratings and Reviews
Mitul Patel
An excellent course with a no nonsense style that PS encompass.
Zahid Ilyas
course was good
Steve Voss
I liked the simple and clear presentation. Also the source material is well positioned. There's not much to dislike really!
Dave is a wonderful trainer and very knowledgeable guy !! thank you for all your support and help