Can Your Data Integrity Process Stand up to Regulatory Scrutiny?
Gain tools and techniques to implement proper controls for data to ensure the integrity and validity of information throughout the data lifecycle. The data integrity process course will provide a practical understanding of:
- The current regulatory focus on Data Integrity
- Relevant regulatory observations
- New MHRA Guidance on Data Integrity
- The need for a Data Integrity process throughout the lifecycle
- The requirement for a data governance system
- How to meet the requirements of 21 CFR Part 11 electronic records and signatures, including the FDA interpretation in the Scope and Application Guidance
- How to meet international regulatory requirements for electronic records and signatures
- How to apply the current industry risk-based good practice approach to compliant electronic records and signatures
- The operation phase of the GAMP® lifecycle
- How new technologies such as cloud computing and mobile applications can impact Data Integrity
Immediately apply the course learning objectives with complimentary copies of the GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems Guide and the GAMP® Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures.
GAMP® is a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry and is a registered trademark of ISPE.