GxP-Regulated Archives and the GxP Archivist

The primary focus of this course is on the implementation of archive procedures within an organisation and the operation of an archive in compliance with GxP (GLP, GCP, GMP). Previously, separate courses were offered for GLP Archivists and for GCP Archivists. The courses have now been combined into a single course as 90% of the content was the same for both courses. It is also beneficial for professional development to understand how GLP and GCP requirements differ from each other and from other requirements. The principles of archiving covered in this course are also relevant for any research or scientific archive. Topics covered are:

  • GxP Records Management Principles
  • Archive-related GxP Regulations
  • The GxP Archivist
  • The GxP Archive
  • Outsourcing GxP Archives

The course is delivered as a one-day training course, or as a series of webinar modules. The webinar modules (corresponding to the topics above) may be booked individually so there is no obligation to complete all five modules. Each module is approximately one hour duration. For a more detailed description of the course contents, click here.

Location and dates – classroom training:

Please contact us to register your interest in attending this course. When we have sufficient numbers, we will contact you to determine the best location and time.

On-demand Webinars:

We are currently reviewing our training platform and not taking direct bookings for the webinars at present. However we can offer access to the pre-recorded videos and presentation materials that replicate the content of the webinars, for a slightly reduced fee. Please contact us to register your interest in accessing these materials.

Prices

No tax/VAT is charged as HSRAA are not registered for VAT.

Cost of 1-day classroom course (including lunch & refreshments): £380 HSRAA Members / £440 Non-members.

Cost of training presentations and videos (all five modules): £175 HSRAA Members / £200 Non-members.

Payment Please note that we do not have the facility to generate invoices manually and to take offline payments. We use third-party booking systems that only provide for online payment by credit/debit card. If you do not have access to a company/corporate card, please make a payment using your personal card and use your company’s standard process for employee reimbursement of expenses.