9:00

Start

Welcome and introductions-

9:15

Session 1 - Expectations for Quality Management controls for Life-science Industries. by Dr. Tony Margetts

• Common regulatory aspects across the GxP product lifecycle
• Application using PIC/S GMP across:
  • Document Control
  • Training Management
  • Quality Event Management
• Inspections and examples of non-compliance

9:45

Session 2 - Overview of an electronic Quality Management System (eQMS). by Mr. Chad Fox

• Introduction to eQMS
• How an eQMS ensures best practices and compliant Quality Management

10:30

Coffee Break

11:00

Session 3 - Electronic CAPA. by Mr. Paul Sanderson

• A best practice CAPA concept and process
• Live walkthrough of a standard CAPA process using electronic forms and reporting tools

12:00

Lunch Break

13:00

Session 4 - IT implementation best practices. Mr David Margetts

• How to implement an IT system and save time and money
  • Project approach
  • Validation
  • Timelines
  • Costs and benefits

13:30

Session 5 - Wrap-up, Q&A

14:00

Closure