The easy part of CDS validation is concept to operational release. The most difficult part is maintaining the validation status of your system through its operating lifetime of many years. This represents the greatest regulatory risk - so what do you have do to ensure continued compliance?

Establishing and maintaining the validation status of the system over its life-time: backup, change control, configuration management and disaster recovery

How to archive and approach ready recovery of electronic records and metadata.

So now you think you are compliant? The role of central IT in maintaining the validation status of a CDS.

This course is intended for all Chromatographers in the Pharmaceutical and Medical Device Industries; contract research organizations that use chromatography data systems requiring validation; chromatographers working in laboratories accredited to 21 CFR 11 (FDA); quality assurance professionals responsible for ensuring compliance with regulations; information technology professionals responsible for supporting these applications in a regulated or accredited environment.

Day 1:

• PRE TEST
• THE FUNDAMENTALS
• SPECIFICATION AND SELECTION

Day 2:

• VENDOR AUDITS
• QUALIFICATION & REPORTING THE VALIDATION EFFORT

Day 3:

• QUALIFICATION & REPORTING THE VALIDATION EFFORT

Day 4:

• DESIGNING PQ TESTS

Day 5:

• MAINTAINING THE VALIDATION
• POST TEST

A variety of methodologies will be used during the course that includes:

• (30%) Based on Case Studies
• (30%) Techniques 
• (30%) Role Play
• (10%) Concepts
• Pre-test and Post-test
• Variety of Learning Methods
• Lectures
• Case Studies and Self Questionaires
• Group Work
• Discussion
• Presentation

To be advised as per course location. This rate includes participant’s manual, Hand-Outs, buffet lunch, coffee/tea on arrival, morning & afternoon of each day.

Daily Course Timings: