DUBLIN--(BUSINESS WIRE)--The "FDA
Trends for Computer System Validation (CSV) Compliance and Enforcement"
conference has been added to ResearchAndMarkets.com's
offering.
This seminar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for Computer System Validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.
This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.
Areas Covered in the Session
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
- "GxP" - Good Manufacturing, Laboratory and Clinical Practices
- 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- Data Archival to ensure security, integrity and compliance
- Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
- Policies and Procedures
- Critical Training
- Recent FDA findings for companies in regulated industries
- Recent trends in technology that need to be addressed in the CSV approach
- Q&A
For more information about this conference visit https://www.researchandmarkets.com/research/rk8kkc/2_day_course_fda?w=4
