21 CFR Part 11 and QMS Software

21 CFR Part 11 and QMS Software Risk-Based Implementation 2020

palo alto, United States
16 December 2020
56 days until the conference begins

Important Dates

Abstract Submission Deadline
6th December 2020

About 21 CFR Part 11 and QMS Software

CGMP-compliant companies must develop / implement formal software controls and usage, starting with proper verification and validation methods. This is an important consideration for a company’s Quality Management System (QMS) and must consider applicable elements of electronic records / signatures / Part 11. The US FDA recently added data integrity and cybersecurity to these requirements. These activities must be properly documented.

Call for 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
  • Senior and middle management
  • QA
  • RA
  • R&D
  • Engineering
  • Software engineering
  • Programmers
  • Sales and Marketing
  • Operations / Production

From the following Industries:

  • Medical Devices, Pharmaceuticals, Dietary Supplements, Biologics, Human Tissue, Combination Products

Suggested formats / content will be shown in the PPT slides.

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