21 - 22 October, 2020
| Online
Webinar Day 2
2:20 pm - 3:00 pm
GCP Compliance Under Covid: Challenges and Regulatory Changes
Elke Ufer -
Quality Manager Compliance, Global Quality Assurance,
Grünenthal
· Discuss the impact of remote working environments on team management and inspection readiness
· Plan ahead for your digital audit environment – common pitfalls and mistakes that can be avoided
3:00 pm - 4:10 pm
HSRAA Masterclass - GCP-Archives and the GCP Archivist
Dora Endreffy -
Senior Manager, QA, GBS QA Quality Governance Risk & Compliance, Global Records Manager,
ICON
Russell Joyce - Executive Committee Member, Health Sciences Records & Archives Association
The workshop has been designed to provide practical training and guidance to those responsible for the management and operation of a GCP-regulated archive or those who need to improve their knowledge and understanding about this topic. The programme defines what constitutes an archive and the specific regulatory requirements, which apply to such facilities, highlighting any differences where they exist between different regulations. Delegates will understand how the basic principles described apply to physical records and to digital records.
Discussions will cover the following principles:
- Records Management Principles
- Regulatory Framework for GxP Archives
- The GxP Archivist
- The GxP Archive
- Use of Third Parties
Dora Endreffy
Senior Manager, QA, GBS QA Quality Governance Risk & Compliance, Global Records ManagerICON
4:10 pm - 4:45 pm
How CROs and Sponsors Can Partner to Better Define Effective Sponsor TMF Oversight
Sarah Dean -
Director, TMF Operations,
Syneos Health
· Outline how the sponsor can initiate conversations with the CRO to understand existing systems, reports, metrics and TMF expectation to establish an oversight process
· Discuss how sponsors with an established oversight process can adapt this for a successful relationship
· Look at how to ensure oversight aligns to the process carried out by the CRO
