Organization: Knowledge Essentials
The GAMP Approach to 21 CFR Part 11 Compliance Course
This GAMP approach to 21 CFR Part 11 compliance course offers a comprehensive overview of the regulation's requirements for electronic systems and provides steps your organization can follow to comply with them to avoid negative audit findings.
This course also provides an exhaustive understanding of the purpose of 21 CFR Part 11. We believe the 'why' is as important as the 'how' when it comes to Part 11 compliance.
As the FDA has very specific requirements as to what should be included to ensure that data captured electronically is accurate and precise, you will find the prescriptive nature of this course appealing to your QA and Regulatory Affairs departments. Lastly, this 21 CFR Part 11 course provides a detailed review of current FDA interpretations and lists the various requirements for 21 CFR Part 11 compliance.
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:
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