Good Documentation Practices / Data Integrity
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Speaker : DON HURD
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When : Wednesday, October 23, 2024
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Time : 01 : 00 PM EST
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Don Hurd has over 40 years of experience in supporting the development of applications of or containing software in regulated industries, the last 20 in medical devices.
- Established company QMS and led company to 13485 registration (12+ years); dual registration to 9001 (8+ years)
- Successfully led numerous companies through standing up a new QMS, leading to ISO 13485 certification
Serving as ‘Quality Manager’ and ‘Management Representative’ for several companies.
This webinar is an overview of good documentation practices and applications to ensure data integrity. All materials subject to regulatory review need to be complete and irrefutable.
Areas Covered
- Basic documentation practices
- Managing data collected during various activities
- E-records and e-signatures
- What metadata is and why it’s important
- Audit trail and why it’s important
Who Should Attend
- Management
- Project Managers
- Quality Engineers
- Purchasing
- Postmarket support
Why Should You Attend
Data integrity is increasingly a focus of regulatory bodies. There has been documentation/data a recent spate of violations uncovered which have led to sanctions – and some increasing public distrust. The increasing emphasis on collecting clinical data throughout the life of the product increases the need for good documentation/data integrity. Not knowing proper documentation practices can lead to regulatory issues.
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$199.00
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