Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11: 2-Day In-Person Seminar training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11: 2-Day In-Person Seminar  

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Regulatory basis for data integrity enforcement, Cultural basis for data integrity issues and difficulty to effect culture change, Assessing data integrity risk and mitigation, How to audit for data integrity issues, How to remediate

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Seminar Summary:

The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety. (see full course description)

 

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Training Course Syllabus:


Learning Objectives:



  • Understanding what data integrity is

  • Why data integrity is a focus by Health Authorities

  • Understand that data integrity is not now - the concepts behind 21CFR Part 11

  • Establish the relationship between company culture and data integrity

  • Understand how data integrity relates to computerized system implementation and usage

  • Applicability of data integrity to legacy systems

  • Relationship between print outs and meta data

  • How to conduct a data integrity risk assessment

  • How to audit for data integrity issues

  • How to mitigate data integrity risk

  • How to remediate data integrity issues


Seminar Summary:

The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety. (see full course description)

print this agenda print agenda for the Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11:  2-Day In-Person Seminar training seminar

 view dates and locations for this seminar

 

 

 

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