29 - 31 October, 2019 | Twickenham Stadium, London, United Kingdom

Pre Conference Workshop Day

10:00 am - 10:30 am Welcome Registration and Coffee

GMP compliance and data integrity is a hot topic within the life sciences sector with regulatory agencies
reporting significant increases in data integrity deficiencies that can impact on product quality and patient
safety. Provided appropriate controls are implemented to prevent and detect data integrity deficiencies,
advances in the digitisation of manufacturing processes increases opportunities to enhance data integrity,
better ensure product quality, optimise processes, improve compliance, and reduce associated risks.
Benefits of Attending:
- Gain a practical understanding of data integrity issues and how it relates to manufacturing
- Explore how best to identify, reduce and prevent potential data integrity breaches
- Examine the viability of your current operations and strategies
- Get up to speed on the most pressing data integrity challenges, practices and for compliant
manufacturing environments.

Workshop attendees should have a basic awareness of GMP / GxP regulations and the use of computerised
systems in regulated environments.

AGENDA:
10:30 Registration and introduction
10:45 Data integrity and governance frameworks for compliant manufacturing
11:30 Networking coffee
11:45 Industry trends and risk-based approaches: Process optimisation without increasing the risk
12:30 Networking lunch break
13:30 Challenges of data integrity and archiving in a manufacturing environment
14:30 Preparing for successful data integrity audits
15:15 Regulatory data integrity observations
15:30 Roundtable discussion / Q&A session
16:00 Close of workshop
Russell Joyce, Executive Committee Member at Health Sciences Records & Archives Association

Russell Joyce

Executive Committee Member
Health Sciences Records & Archives Association

Dora Endreffy, Senior Manager, QA, GBS QA Quality Governance Risk and Compliance, Global Records Manager at ICON

Dora Endreffy

Senior Manager, QA, GBS QA Quality Governance Risk and Compliance, Global Records Manager
ICON

4:00 pm - 4:30 pm Close of Pre-Conference Workshop Day