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The topic is an overview of good documentation practices and applications to ensure data integrity. All materials subject to regulatory review needs to be complete and irrefutable.

The key learning objectives include what’s “good” in documentation practices, techniques to ensure “good” data is captured, and how data integrity is maintained throughout the life of the data.

Data integrity is increasingly a focus by regulatory bodies. There has been 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.

Areas covered will include:

  • Basic documentation practices
  • Managing data collected during various activities
  • E-records and e-signatures
  • What metadata is?
  • Why is metadata important?
  • What an audit trail is and why it’s important?

This webinar is intended for people in the medical device or IVD industry. All product documentation and collected data are subject to regulatory review and need to be presented in a manner that promotes trust and understandability.

Don Hurd has over 35 years of experience in supporting the development of applications or containing software in regulated industries, the last 17 in medical devices. With his diverse background, Don provides a unique insight into driving product quality and ensuring the high productivity of development organizations. He is currently the vice president of Quality and Validation Services for The Realtime Group, a contract R&D firm that specializes in serving the regulated industries, primarily medical devices. 

In this role, Mr. Hurd led the company to certification in both ISO 9001 and ISO 13485, maintaining certification for nearly 15 years. In his role at Realtime, he supports clients in efforts ranging from Quality Management System development, deployment, and remediation; product and development quality planning; verification and validation of products, product software, and non-product software; supplier qualification, approval, and management; transitioning product from development to manufacturing; supporting post-market vigilance / surveillance; and interfacing with ISO auditors and FDA inspectors. He has been an ASQ certified quality auditor since 2009. He is active in the ASQ Biomedical Division Discussion Group, ASQ Audit Special Interest Group, and bionorthTX, holding leadership positions in each of them.

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