The Good Distribution Practice MHRA Symposium 2019 at Nova Hotel in London proved to be a resounding success; it is always a pleasure working with the MHRA and Cogent Skills would like to say a big thank you to all the staff that helped put together such an informative event.
We are grateful for the continuing support and contribution from the MHRA.
Each year, these compelling events always provide the latest information and guidance on changes to legislation and the increasing complexity within the manufacturing and distribution chain.
The symposium gave a deeper insight into the role of the responsible person and gave delegates a highly interactive ‘hands on’ learning experience with detailed workshop sessions, reviewing actual sample deficiencies found by regulators and explained how to address and improve compliance in these critical areas.
To further reinforce the principles of quality management, Cogent Skills has worked with the MHRA and industry stakeholders to develop the Responsible Person in GDP training standard, setting the benchmark for quality training in this area. Over recent years Cogent Skills, with the guidance of the MHRA have been able to map a set of courses to this standard, ensuring that anyone undertaking one of these courses will meet the industry standard. The courses are delivered by Cogent Skills approved providers who have been through the mapping process.
The courses are aimed at Deputy RPs, Directors, Managers, Quality Assurance staff, Supervisors and any other personnel involved with the storage and distribution of human medicines. They are also recommended for anyone with ambitions to set up a wholesaling business.
The courses provide a full and comprehensive insight into the latest regulations, followed by an interactive session to test attendees’ knowledge of the subject.
If you would like to take a more detailed look into the RP’s role with emphasis on the Cogent Gold Standard, we strongly recommend that you take a look at our course.
By the end of this training course you will:
- Understand the importance of GDP
- Understand the importance of competent authorities
- Understand Quality Management Systems and Document Control
- Become familiar with the latest GDP Guidelines EU 2013/C 343/01
- Understand the role of the Responsible Person and the Gold Standard
- Dangers of Falsified Medicines
- Implementation of Quality Risk Management
- Have an awareness of what to expect and how to deal with an inspection.
Certification
Following the completion of this course, a personalised training certificate recognised by the MHRA is provided to delegates.
Please contact us on 01325 740900 and one of our advisors will match you with one of our assured providers who have mapped their course to the standard.
Are you a provider looking for Gold Standard Recognition?
As the custodian of the Gold Standard and the Training Standard for the Responsible Person, we are expertly positioned to map your training & we can provide:
Analysis: We will provide you with the structure to review your current training and demonstrate how it meets the learning objectives and competencies identified in the standard.
Mapping: We will verify that your course maps to the standard.
Recognition: Once we confirm your course meets the standard, you will receive a Cogent Skills certificate stating that your training content has met the standard.
Certificates: Once you have demonstrated that your delegates have met the learning objectives, we will organise certificates for your delegates showing that they have had training that meets the training standard. This certificate will be validated with the Cogent Skills and MHRA logo.
The MHRA* also recognise the standards in the Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors.
Click Here for more information on this process.
