We are able to develop and deliver a range of bespoke training programmes on records management topics, including Executive Briefings for Senior Management. We will also deliver your own in-house developed records management training programme and can customise courses to fit your organisation. All courses can be delivered on site or off site.
In collaboration with the Scientific Archivists Group and Heathbarrowcliff Consulting, we provide the following standard training courses:
Management of Electronic Records (1-day)
There are many excellent companies and associations that provide general training on the management of electronic records and we do not attempt to complete with these. In collaboration with the Scientific Archivists Group, we provide a one-day course that is specifically aimed at colleagues working in GxP regulated environments. We therefore approach the concepts of electronic records from the perspective of meeting the expectations and requirements of agencies such as the MHRA, EMA and FDA. The case studies we use and record-keeping systems we discuss are especially relevant to the pharmaceutical/biotechnology R&D environment and other areas of health sciences. Details of this course and online booking can be found HERE.
TMF Essentials (1-day)
This one-day course would be suitable for anyone with responsibility for establishing or maintaining trial master files. The course covers some of the underlying records management principles, such as “what is a record?” and “what is the record life-cycle?”. We then covers the regulatory requirements for the trial master file, including its creation, maintenance and long-term retention. A key component of this session is the TMF Reference Model. We also cover a range of practical issues associated with TMF maintenance. This content is applicable for both paper and electronic trial master files. Details of this course and online booking can be found HERE. If the scheduled date(s) are not convenient, this course can be run on demand if the minimum number of delegates is met.