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Mastering 21 CFR Part 11; Electronic Records and Signatures for Pharmaceutical and Medical Device Compliance

Mastering 21 CFR Part 11; Electronic Records and Signatures for Pharmaceutical and Medical Device Compliance

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Mastering 21 CFR Part 11: Electronic Records and Signatures for Pharmaceutical and Medical Device Compliance

Mastering 21 CFR Part 11: Electronic Records and Signatures for Pharmaceutical and Medical Device Compliance

This comprehensive course is designed to provide participants with a thorough understanding of the regulations and guidelines for electronic records and signatures in the pharmaceutical and medical device industries.

Upon completion of this course, participants will receive a certificate issued by The Art of Service.



Course Features

  • Interactive and engaging content
  • Comprehensive and up-to-date information
  • Personalized learning experience
  • Practical and real-world applications
  • High-quality content developed by expert instructors
  • Certificate issued upon completion
  • Flexible learning format
  • User-friendly and mobile-accessible platform
  • Community-driven discussion forums
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking features


Course Outline

Chapter 1: Introduction to 21 CFR Part 11
  • Overview of 21 CFR Part 11
    • History and background of the regulation
    • Purpose and scope of the regulation
  • Key Concepts and Definitions
    • Electronic records and signatures
    • Computerized systems and software
Chapter 2: Electronic Records
  • Types of Electronic Records
    • Lab data and results
    • Clinical trial data and results
  • Requirements for Electronic Records
    • Validation and verification
    • Data integrity and security
Chapter 3: Electronic Signatures
  • Types of Electronic Signatures
    • Digital signatures
    • Biometric signatures
  • Requirements for Electronic Signatures
    • Authentication and authorization
    • Signature manifestation and verification
Chapter 4: Computerized Systems and Software
  • Types of Computerized Systems
    • Laboratory information management systems (LIMS)
    • Clinical trial management systems (CTMS)
  • Requirements for Computerized Systems
    • Validation and verification
    • Data integrity and security
Chapter 5: Validation and Verification
  • Validation of Computerized Systems
    • User acceptance testing (UAT)
    • Installation qualification (IQ)
  • Verification of Electronic Records and Signatures
    • Data integrity and security
    • Compliance with 21 CFR Part 11
Chapter 6: Data Integrity and Security
Chapter 7: Compliance with 21 CFR Part 11
Chapter 8: Audits and Inspections