2 Day Course: FDA Trends for Computer System Validation (CSV) Compliance and Enforcement (Boston, MA - June 25-26, 2018) - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--May 15, 2018--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 SessionComputer 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
View source version on businesswire.com:https://www.businesswire.com/news/home/20180515005782/en/
Laura Wood, Senior Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics:Drug Discovery,Pharmaceutical Manufacturing
KEYWORD: UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: TECHNOLOGY DATA MANAGEMENT HEALTH PHARMACEUTICAL FDA
SOURCE: Research and Markets
Copyright Business Wire 2018.
PUB: 05/15/2018 07:19 AM/DISC: 05/15/2018 07:19 AM