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2020 - Data Integrity: FDA/EU Requirements and Implementation
Date2020-06-18 - 2020-06-19
Deadline2020-06-08
VenueCopenhagen, Denmark 
KeywordsData integrity workshop; Gxp regulations; Fda part 11
Topics/Call fo Papers
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
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
- The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities
- Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
- Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact
- How to Conduct an ACH Risk Assessment and Develop an Effective ACH Risk Management Program
- Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
Last modified: 2020-05-04 02:12:43