Events Archive - Health Sciences Records and Archive Association

GxP-Regulated Archives and the GxP Archivist: Module 1 Records Management

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...Read More

GxP-Regulated Archives and the GxP Archivist: Module 2 Regulatory Framework for GxP Archives

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...Read More

GxP-Regulated Archives and the GxP Archivist: Module 3 The GxP Archivist

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...Read More

GxP-Regulated Archives and the GxP Archivist: Module 4 The GxP Archive

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...Read More

GxP-Regulated Archives and the GxP Archivist: Module 5 Use of Third Parties

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....Read More

HSRAA 2020 Annual Conference Booking

Book Your Tickets for the 2020 Conference For more information about costs and booking options, see below No bookings can be accepted after 9th April 2020. Please select the tickets you wish to purchase. HSRAA-member prices are only valid for...Read More

An Introduction to GCP for Records Managers & Archivists

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...Read More

An Introduction to GLP for Records Managers & Archivists

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...Read More