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Part 11 related observations - PowerPoint PPT Presentation

FDA's on-going Part 11 Inspection Program

FDA's on-going Part 11 Inspection Program

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about Part 11 inspections, e.g., what inspectors are looking at what are major findings. The seminar will have the answers. In addition, using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.

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139 views • 7 slides
How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about Part 11 inspections, e.g., what inspectors are looking at what are major findings. The seminar will have the answers. In addition, using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.

★ ★ ★ ★ ★

106 views • 5 slides

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