The Computer Systems Validation (CSV), Data Integrity, 21 CFR Part 11 Compliance and GAMP 5 2017 is dedicated to proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
Topics
- Computer Systems Validation Points
- Role of FDA
- Benefits of Validation
- Why Validation?
- 21 CFR Part 11 Compliance
- Understanding GAMP 5
- Data Integrity & Security
- Annex 11
- ALCOA
- Where & How to know the occurrence of data integrity failures
- URS, FS, DS, TRM, SR, IRA, FRA
- Validation Master Plan (VMP)
- Related Warning Letter Points
- IQ, OQ, PQ
- Risk Assessment
- Computer Systems Validation Deliverables
Who should Attend
Attendees from:
- Quality Control Laboratories Companies
- Pharmaceutical Development Companies
- Quality Departments of Finished Product Manufacturers
- Quality Departments of API Manufacturers
- Biotech Companies
- Medical Device Companies
- Clinical Research Organisations
- Contract Laboratories
- Every Company that needs to comply with FDA Regulations
- Suppliers and Service Providers of Instruments and Computer Systems
