Role of the Responsible Person (incorporating the Gold Standard) and GDP for Medicinal Products
This one day intensive course is delivered throughout the UK and can also be delivered in-house. The day is very interactive and uses real examples with opportunities taken for group discussion throughout the training day.
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This Course is Aimed at |
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Existing Responsible Persons, Deputy RPs, Trainee RPs, Quality Managers, Warehouse Managers & Operatives, both WDA(H) and (V) holders. Anyone needing an in-depth understanding of the requirements of a Wholesale Distribution Authorisation and Good Distribution Practice of Medicinal Products. |
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Overview |
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An intensive, practical, one day training course on The Role of the Responsible Person and all of the Good Distribution Practice Guidelines. The course is designed to be an enjoyable day, culminating in real learnings, applicable to each delegate’s unique working environment. The course covers the Good Distribution Practice Guidelines (2013/C 343/01) in detail from the Responsible Person’s perspective. Emphasis is placed on interaction of delegates, team activities and encouragement to ask questions and share experiences. Real examples are provided throughout the training, with many examples of documentation as required by the MHRA inspectorate. Each delegate receives a comprehensive reference folder, complete with invaluable guidance and documentation examples, and a personalised, traceable training certificate. Delegates are encouraged to ask questions, both during the course and via email to the trainers in the week following the training. Always held in a Conference Centre of Excellence, with outstanding facilities and catering. The trainers are Consultant Responsible Persons, who regularly attend MHRA inspections and are therefore in a unique position to provide information on different styles of inspectors, and very comprehensive coverage of inspections and GDP requirements. NB: The new Code Of Practice for Responsible Persons (published March 2016) is also incorporated into the training course. Disclaimer: * Please note that the PMN Group Responsible Person course has not been mapped to the Responsible Person Gold Standard course. |
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Programme Content and Key Areas |
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Introductions Section 1. The regulatory background Section 2. Responsible Person - Overview & Understanding Section 3. Introduction to the Gold Standard Section 4. The Gold Standard - in detail, incorporating in depth GDP guidance Section 5. MHRA Inspections & Applications Section 6. Common Deficiencies & Q&A Session Test! One to one discussion with trainers. |
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Learning Outcomes |
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The delegate:
To book now contact us. |
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Contact Us01325 740900Send us an enquiry |
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