subject: 21 Cfr Part 11: Complying With Part 11 Regulation - Understanding The Predicate Rule [print this page] Description: Description:
Why is 21 CFR Part 11 important? Simply because organizations across the board will have to adapt this regulation in future. What does this regulation have that makes it so important? This regulation covers electronic signatures and electronic records, which will be the documents tomorrows world will switch over to. Why they need to do so is for a very practical purpose: The huge difference this kind of documents will make to the speed of communication and to the globes eco system, as they facilitate green use.
This webinar will help participants understand the nature of this regulation and give them insights into how they can be used by an organization. Although the world is moving towards this form of records; there is surprisingly little knowledge of these across most organizations. These are the areas this session covers:
oOverview of the Part 11 regulation
oDescription of how to ensure compliance with Part 11
oInternal and External audits for compliance with Part 11
Jasmin NUHIC is a Senior Manager, Manufacturing Engineering at Medtronic, Inc. (Peripheral Therapies) in Zrich, Switzerland, and is a 21 CFR Part 11 Subject Matter Expert. He is also Adjunct Professor at DeVry University and Keller Graduate School of Management.
As a Quality professional, Jasmin NUHIC has a proven record of leading teams that deliver results with full scope, below budget and ahead of schedule through process optimization, business growth and talent development. During the over 12 years of his professional life in the FDA-related industries; Nuhic has gained vast experience in operations, quality management systems, manufacturing, concurrent engineering, program management and information systems. He has obtained over 25 different certifications in leadership, quality, software validations and related areas.
He has earned positive and verifiable track record in helping organizations implement continuous improvement and cost saving initiatives through the use of lean sigma and six sigma methodologies. He has imparted this expertise through webinars on these topics, which usually have high attendance and have come in for appreciation.
