The ‘Making’ of a Good Responsible Person

The ‘Making’ of a Good Responsible Person

Despite the MHRA’s guidance note 6 there is a lack of a clearly defined and standardised route into becoming a trained, experienced, and effective Responsible Person (RP), and consequently the MHRA are now placing a greater emphasis on the suitability of a licence holder’s RP, perhaps in an attempt to ensure that all roads eventually lead to the same destination or to gradually develop and define the necessary route, or maybe both…

Standards for Everyone…

For the last 3 years, when delivering GDP Training, and when it comes to the subject of Transportation – and the related GDP requirements – there has always been stock comments and specific observations…

Changes in Medical Device Regulation 1.

There have been major regulatory changes within the Medical Device market, with more coming in the form of the Medical Device Regulations (MDR) which is in the process of being implemented at the moment. The main change that has affected the market over the last...