Outsourced Activities and Responsibilities of the Licence Holder and Responsible Person
This course covers the responsibilities of the Responsible Person (RP) and the Licence Holder (LH) in respect of the Quality System, and further includes the subject of Outsourced Activities and the compliance objectives required for this activity.
Chapter 1.2 (Quality System) of the EU GDP Guidelines 2013/ C 343/01 advises that:
“The system for managing quality should encompass the organisational structure, procedures, processes and resources… …and be fully documented and its effectiveness monitored”.
Further notes are available in the Human Medicine Regulations (2012), parts 43 through to 45.
Although all staff are responsible for maintaining the QMS, it falls to the RP and LH to ensure that it is being engaged correctly through procurement, transport, storage and distribution and that the staff are fully trained and GDP-aware, both on the floor of the warehouse as well as in the office and administration work.
This course works both as a refresher course and as part of your initial training towards qualification for the positions of LH and RP. See also our Blog on this topic.
The learning objectives of this course are:
- To understand the responsibilities of the Responsible Person and Licence Holder within the Human Medicine Regulations 2012 and EU GDP Guidelines 2013/ C 343/01, in respect of outsourced activities.
- To understand the structure and importance of a robust Quality Management System.
- To understand the role and responsibilities of the Contract Giver and the Contract Acceptor, and the key elements required within their Technical Agreement.
You will also learn about:
- The typical format and content of a Technical Agreement.
- The Plan-Do-Act-Check cycle.
- Tools for continuously improving the Quality System.
Click the button below for supporting documentation about GDP if you wish to continue your learning journey.
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Human Medicines Regulations 2012 EU GDP Guidelines 2013/C 343/01 ICH Guideline Q9 on Quality Risk Management
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Ratings and Reviews
John Curran
very clearly communication of key knowledge points.
Heather Pasquale
I liked how the training was split up, including the pre and post-test and questions to test your knowledge along the way.
luke@genetechpharma.co.uk
The course covered all the basics and easily referenced the 2013/C 343/01 Guidelines which enabled me to follow the material covered. I will be coming back for my refresher.
I liked the detailed breakdown of requirements and obligations of an RP and LH