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2020 - Data Integrity and Privacy for FDA Regulated Industries



VenueOnline Event, USA - United States USA - United States

KeywordsData integrity; Data privacy; CFR Part 11


Topics/Call fo Papers

What is Data Integrity
Data Integrity Framework
Data Privacy
Data Life Cycle
Regulations: 21 CFR 11, Annex 11, GAMP 5
IT systems validation
Data Integrity Risk Assessment
Change Control
Electronic Approvals
Choosing vendors and outsourcing
Data privacy and protection of subject data
Quality Assurance and Quality Control
Monitoring and auditing of data
Audit trails, access controls and user permissions
Handling Errors and Corrections
Storage and Transfer of Data

Last modified: 2020-05-05 23:54:39