Updated for 2020, this is a one day refresher course for Responsible Persons (RP) and Deputy RPs that have already attended their initial RP training.
Section 2.4 of Directive 2013/C 343/01 states that RPs should receive regular training to maintain their competence in GDP. Indeed, MHRA Inspectors expect to see evidence of this type of training in your training file and you should attend this type of training every 18 to 24 months.
This course is designed to meet this ongoing requirement, whilst also updating you on any regulation changes, share best practice ideas, how to address common deficiencies and discuss industry hot topics..
In addition, the course also gives an RP the opportunity to network and share experiences with other RPs in a collaborative, open environment.
The refresher course is aimed at RP’s and Deputy RP’s who have already undertaken initial RP training but who need to keep updated with current regulations and expectations of the competent authorities for Continuing Professional Development (CPD). Note, it is not a suitable alternative for those who have yet to undergo initial RP training.
This ‘update’ course would also benefit quality managers, and personnel in regulatory, compliance, distribution, warehousing, supply chain management and customer service who need to appreciate the implications of the changes. It is designed for all those who need to understand the revised key GDP quality components necessary to operate as a holder of an MHRA or EU.
By the end of the course you will:
- Address Section 2.4 of Directive 2013/C 343/01 requirement for ongoing training and personal development
- Understand the very latest EU directives/regulations and guidelines (including the ‘Orange Guide’)
- Be aware of common deficiencies, inspection hot topics and how to stay compliant
- Share best practice ideas, problem solve and network