The Computer Systems Validations, 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.
The Computer Systems Validations, Data Integrity, 21 CFR Part 11 Compliance and GAMP 5 2017 covers topics such as:
- 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
The Computer Systems Validations, Data Integrity, 21 CFR Part 11 Compliance and GAMP 5 2017 brings together 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