Workshop 1 - Introduction to Computer Systems Validation?
An overview of why computer systems validation is important and applicable to Life Sciences companies, how regulatory expectations are defined and enforced and an update on current trends and issues

• The regulatory basis for computer systems validation.
• EU and US regulatory bodies, inspection trends and enforcement approach.

Workshop 1 continued - What is Computer Systems Validation?

• Overview of available guidance on computer systems validation.
• Electronic Records and Electronic Signatures (US 21CFR Part 11 and PIC/S guidance).
• Update on Regulatory issues affecting computer systems validation.

Lunch and Networking

Workshop 2 - Approach to Computer Systems Validation.
A review of typical computer system validation issues that impact on small to medium sized enterprises in the Life Sciences sector and guidance on planning for compliant business growth.

• Validation of desktop applications (spreadsheets, databases, folders and files).
• Validation of small to medium configurable systems such as LIMS and manufacturing systems.
• Validation of computer based R&D equipment and systems.
• Qualification of IT infrastructure.

Questions and Answers
Summary, Feedback and Close