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2020 - Data Integrity: FDA/EU Requirements and Implementation
Date2020-03-26 - 2020-03-27
Deadline2020-03-16
VenueSan Diego, CA, USA - United States 
KeywordsData integrity workshop; Gxp regulations; Fda part 11
Topics/Call fo Papers
Attendees will:
Understand what data integrity is and why it is so important for patient safety
Recognise that there are many causes of data integrity breaches
Know the current regulatory expectations
Appreciate the difference between static and dynamic records, and be able to apply acceptable strategies for the retention of both types of record
Be able to categorise and validate GxP computerised systems according to GAMP 5
Understand the importance of training and quality culture in avoiding regulatory enforcement action
Learn how to respond to data integrity observations in inspection reports
Learn how to prevent, detect and remedy data integrity problems
Understand what data integrity is and why it is so important for patient safety
Recognise that there are many causes of data integrity breaches
Know the current regulatory expectations
Appreciate the difference between static and dynamic records, and be able to apply acceptable strategies for the retention of both types of record
Be able to categorise and validate GxP computerised systems according to GAMP 5
Understand the importance of training and quality culture in avoiding regulatory enforcement action
Learn how to respond to data integrity observations in inspection reports
Learn how to prevent, detect and remedy data integrity problems
Other CFPs
- Biostatistics for the Non-Statistician
- Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
- Preparing for FDA's New Import/Export Trauma in 2020
- A Comprehensive View of FDA Regulations for Medical Devices
- Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
Last modified: 2020-01-14 04:04:13