This webinar will define what each of these terms mean as defined within the FDA 21 CFR Part 820, including "human translations" to these often hard-to-read regulations.

Denise Wrestler

• September 20, 2019
• 60 Minutes
• $110.00
• Enroll

This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System

Denise Wrestler

• October 3, 2019
• 60 Minutes
• $110.00
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This presentation will cover the FDA regulations (21 CFR Part 820.198) regarding complaint handling, how to best approach complaints (including initiation, investigation, evaluation, and follow-up verification)

Denise Wrestler

• October 24, 2019
• 60 Minutes
• $110.00
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The document management system for medical device industry should help companies have control over critical activities such as

Denise Wrestler

• November 5, 2019
• 60 Minutes
• $110.00
• Enroll

A robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations, changes, and re-visits to the initial design are clearly documented.

Denise Wrestler

• November 18, 2019
• 90 Minutes
• $110.00
• Enroll