21 CFR Part 11: Complying with Part 11 Regulation - Understanding the Predicate Rule

Training Options

  •   Duration: 2 Hours  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $345.00
  • Refund Policy

Overview:

Overview of the Part 11 regulation; Description of HOW TO ensure compliance with Part 11; Internal and External audits for compliance with Part 11; Key terms and definitions; Example of solid compliance; Examples of non-compliance; Examples of Warning Letters; Tools for compliance; Further readings, trainings and opportunities related to Part 11.

Why should you attend :More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using more and more of the computer technologies. Part 11 is a regulation that regulates the technology when it comes to electronic signatures and electronic records.

In a time of global economy when and where time is of essence, having an ability to access  records from any location around the world is more critical than ever, and for the same reason, electronic records will be more needed and desired in each organization. In addition, approval of documents and records in a timely fashion is absolutely needed at all times, and being able to do just that via an electronic media is understood. For both, electronic signatures and electronic records, the organization shall comply with the Part 11 regulation.

Areas Covered in the Session
  • Overview of the Part 11 regulation
  • Description of HOW TO ensure compliance with Part 11
  • Internal and External audits for compliance with Part 11
  • Key terms and definitions
  • Example of solid compliance
  • Examples of non-compliance
  • Examples of Warning Letters
  • Tools for compliance
  • Further readings
  • trainings and opportunities related to Part 11
Who Will Benefit:
  • Quality Managers
  • Quality Engineers
  • Small Business Owners
  • Internal and External Auditors
  • Management Reps
  • FDA Inspectors
  • Consultants
Jasmin NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation.


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