21 CFR Part 11 specifies requirements for handling records covered by FDA regulations that exist in an electronic form. This GAMP approach to 21 CFR Part 11 compliance course offers an overview of these requirements for electronic systems and how to comply with them to ensure compliance. The course also provides good understanding of the purpose of 21 CFR Part 11 compliance.

The FDA regulation 21 CFR Part 11 has very specific requirements of what should be included to ensure that data captured electronically is accurate and precise. This 21 CFR Part 11 course provides a detail review of current FDA interpretations and list the various requirements for 21 CFR Part 11 compliance.

Click here to get the GAMP Approach to 21 CFR Part 11 Compliance course.

21 CFR Part 11 Applicability:

21 CFR Part 11 regulates the use of electronic records and electronic signatures required by governing manufacturing processes in FDA regulated industry.

21 CFR Part 11 applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of FDA regulated products by firms which choose to use electronic records or signatures. This course identifies a few practical examples of 21 CFR Part 11 compliance. Therefore, this course will be valuable for all those professionals who use computer systems to perform their job functions.

Subjects such as 21 CFR Part 11 compliance are multi-faceted and complex and can be better understood after going through this course. This course describes GAMP Records and the Data Integrity Guide and provides possible application of the risk management principle.

Course Objectives:

  • Explain the purpose of 21 CFR Part 11 compliance.
  • Recognize the current FDA interpretations.
  • List the various requirements for 21 CFR Part 11 compliance.
  • Identify a few practical examples of 21 CFR Part 11 compliance.
  • Describe GAMP Records and the Data Integrity Guide.
  • Identify a possible application of the risk management principle.

Click here to get the GAMP Approach to 21 CFR Part 11 Compliance course.