• February 17, 2020 - December 31, 2020
    8:00 am - 11:55 pm

An overview of essential records management principles, including the records lifecycle. This will demonstrate the importance of good practices during the creation and use of records prior to their archiving and how this can impact archive process. We will describe the function of a records retention schedule and how this relates to archive management. We (more…)

Venue:  

Description:
Joining details will be communicated to you shortly before the course date.


  • February 18, 2020 - December 31, 2020
    8:00 am - 5:00 pm

This session will review the current regulations pertaining to archiving and long-term preservation of records, identifying the commonalities between GxP regulations and highlighting regulations that are specific to GCP, GLP, etc. The primary focus will be on regulations pertinent to the main ICH regions (ICH, EU and Japan) and OECD principles. We will include regulations (more…)

Venue:  

Description:
Joining details will be communicated to you shortly before the course date.


  • February 19, 2020 - December 31, 2020
    8:00 am - 5:00 pm

This session will describe the roles and responsibilities of the nominated Archivist and review the roles and responsibilities of other key stakeholders, including: Study Director / Study Manager Facility Manager / Sponsor Study Team Members, including monitors Third parties, including laboratories, principal investigator We will review the differences between an Archivist and Records Manager. To (more…)

Venue:  

Description:
Joining details will be communicated to you shortly before the course date.


  • February 20, 2020 - December 31, 2020
    8:00 am - 5:00 pm

This session will review the features of an archive that meets regulatory expectations, including both physical archives and electronic archives. We will discuss archive design and structure, security, and environmental controls. We will review the day-to-day operation and management of a regulated archive, including processes such as receipt and indexing, maintenance (e.g. reviews), access control, (more…)

Venue:  

Description:
Joining details will be communicated to you shortly before the course date.


  • February 21, 2020 - December 31, 2020
    8:00 am - 5:00 pm

Third parties (vendors) may be used during the conduct of a study and/or to assist with the archiving of study records. This session will identify different scenarios for involving third parties and will review issues that need to be managed. We will discuss how to select a suitable vendor, what contractual issues need to be (more…)

Venue:  

Description:
Joining details will be communicated to you shortly before the course date.


  • April 22, 2020
    1:00 pm - 5:00 pm

This will be an interactive half-day workshop covering the key requirements of GCP focusing on good document management, TMF management and archiving. The session will cover ICH GCP (R2), EU and UK clinical trials legislation and FDA legislation. The interactive sessions will be designed to illustrate how the GCP regulatory requirements impact on the roles (more…)

Venue:  

Venue Phone: 01753 640000

Venue Website:

Address:
Burfield Road, Windsor, Berkshire, SL4 2JJ, United Kingdom

Description:
A distinctive hotel in Windsor The story of De Vere Beaumont Estate in Old Windsor is a very British one; a tale of democracy, royalty, education


  • April 22, 2020
    1:00 pm - 5:00 pm

This will be an interactive half-day workshop covering the key requirements of GLP and GMP focusing on good document management and archiving. The session will cover UK, EU and FDA regulations and legislation. The interactive sessions will be designed to illustrate how the regulatory requirements impact on the roles of document managers and archivists in (more…)

Venue:  

Venue Phone: 01753 640000

Venue Website:

Address:
Burfield Road, Windsor, Berkshire, SL4 2JJ, United Kingdom

Description:
A distinctive hotel in Windsor The story of De Vere Beaumont Estate in Old Windsor is a very British one; a tale of democracy, royalty, education