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2020 - 21 CFR Part 11 and QMS Software Risk-Based Implementation
Date2020-12-16
Deadline2020-12-06
VenueOnline event, USA - United States 
KeywordsCGMPs; ISO 13485; CGMPs
Topics/Call fo Papers
U.S. FDA's expectations / requirements
Recent Data Integrity and Cybersecurity regulatory requirements
Roles of Verification and Validation; Legal requirements; Recommended “best practices”
The development of a 21-year long, field-tested FDA "Model"
Basic development, implementation, use, and decommissioning expectations
21 CFR Part 11 (electronic records / signatures) requirements, and its implementation
Expected Regulatory Deliverables
Applicable standards and industry-recommended Guidelines
Recent Data Integrity and Cybersecurity regulatory requirements
Roles of Verification and Validation; Legal requirements; Recommended “best practices”
The development of a 21-year long, field-tested FDA "Model"
Basic development, implementation, use, and decommissioning expectations
21 CFR Part 11 (electronic records / signatures) requirements, and its implementation
Expected Regulatory Deliverables
Applicable standards and industry-recommended Guidelines
Other CFPs
- Medical Device Cybersecurity and FDA Compliance
- Improving Productivity with the Office 365 Suite
- Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
- 7th International Conference of Advances in Materials Science and Engineering (MAT 2021)
- 7th International Conference on Bioscience & Engineering (BIOE 2021)
Last modified: 2020-10-06 17:29:07