2019 - Good Documentation Practices / Data Integrity

OVERVIEW
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.
LEARNING OBJECTIVES
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.
WHY SHOULD YOU ATTEND
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
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?
WHO WILL BENEFIT?
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.
SPEAKER
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.
For more detail please click on this below link:
http://bit.ly/38MkZz8
Email: support-AT-247compliance.com
Tel: +1-(510)-868-1040