21CFR Part11 Conformance for Medical Devices

Product Id : FDA97
Instructor : Edwin Waldbusser
Feb 08, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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The attendee will learn how to comply with FDA's 21 CFR Part 11 guidance, which addresses the use of electronic records and electronic signatures (ER/ES). There are specific security and authentication requirements that are not necessarily covered by the standard computer system validation (CSV) approach, and go somewhat beyond this.

We will also address the roles of people involved in validating and supporting the systems, aside from just the standard system users. There are many tasks and functions they need to understand in order to be in compliance.

Why Should You Attend:

It is important that everyone in the company, regardless of authority level, understands 21 CFR Part 11 and the key benefits that the regulation can bring to the organization. FDA expects compliant systems—or at least an inventory of known noncompliant systems, with a plan for bringing them into compliance—and its enforcement actions have made it very clear that delay, avoidance, and rushed compliance are bad choices for approaching the challenge. Far better that the organization initiate its own measures for compliance than that the heavy hand of FDA dictate compliance.

This webinar will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire lifecycle.

Learning Objectives:

  • Meet FDA regulations for electronic records and signatures
  • Achieve compliant document management and records storage
  • Benefit from user/time stamping of records
  • Leverage unalterable document history including baselines
  • Improve management oversight with automated reports

Session Highlights:

  • Accurate traceability for all artifacts throughout the entire lifecycle
  • Intuitive interface increasing end user acceptance and productivity
  • Out-of-the-box templates and processes can be easily customized
  • Real-time monitoring and reporting of defects
  • Fully traceable management of product complaints and adverse events
  • Automated routing, approval and incorporated escalation for overdue tasks

Who Will Benefit:

  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Laboratory Managers
  • Analytical Chemists
  • Manufacturing Managers
  • GMP Training Specialists
  • Computer System Validation Specialists
  • Supply Chain Specialists
Speaker Profile:

Edwin Waldbusser is a Regulatory Consultant at Medical Device Advisors. He is holder of BSc. Mechanical Engineering and Master in Business Administration.

After more than 20 year of work and retirement from management of medical devices development (5 patents), Mr. Waldbusser is now a highly experienced consultant. He has been a consultant in the fields of risk analysis, software validation and design control for 8 years now.

Mr. Waldbusser is a Lloyds of London ISO 9000 Lead Auditor. He is also a board member of Thomson Reuter Expert Witness network.


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