This is the second in a set of three posts centred around the Responsible Person named on a Wholesale Distribution Authorisation (WDA). This post has been written to enhance the appointment of the RP.
I joined MHRA in August 2009 as a GDP inspector. During that time I have met a wide range of Wholesale Distribution Authorisation (WDA) holders on inspection and at the annual MHRA symposia and other meetings. I enjoy my job and enjoy meeting the WDA holders and their teams who, by and large, are trying to do a good job in the medicines supply chain.
Prior to joining MHRA, I worked as a project manager at NHS Blood and Transplant and in NHS hospital aseptic dispensing. Most activities focussed on project management, quality assurance, aseptic manufacture and learning and development; and all are supported by formal qualifications.
Recent project work has included working with Cogent to develop the Responsible Person Gold Standard and working with the Maritime and Coastguard Agency to improve compliance with the Human Medicines Regulations 2012 and Good Distribution Practice in the maritime sector.
Since moving into the role of Senior GDP Inspector, I aim to further develop engagement with stakeholders.
This is the first in a set of three posts centered around the RP named on a WDA. This post provides information on external training recognition and training providers. The second of these three posts aim to enhance the appointment of the RP and the third post will place a particular emphasis on the engagement of a contract/consultant RP.
To assist wholesalers to understand areas where significant GDP failures have been observed, the GDP Inspectorate has published the inspection deficiency data for 2016.
Welcome to this, the next Inspectorate post. My name is Madeleine Ault and I have been with MHRA for over 6 years now. In that time I have inspected a wide range of wholesalers. These inspections cover large and small wholesalers, …