Change Control Systems for Medical Devices Current Best Practices for FDA-Compliant Systems

Instructor: Jeff Kasoff
Product ID: 701785
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This change control training will discuss the best practices to create a FDA compliant system.

Why Should You Attend:

It is well known that document change control is a critical requirement for FDA-regulated companies. However, this can be a time- and paper-consuming process, in which even the simplest of changes requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. The best document change control systems are those that are fast and effective.

This presentation will review the QSR requirements for document change control, and provide a streamlined process - Many companies can spend MUCH LESS preparing MANY FEWER documents, and still be in compliance with the regulations; is yours one of these?

Areas Covered in the Webinar:

  • QSR requirements for document change control.
  • Description of typical document change control system in use.
  • Streamlined document change control process.
  • Paper-free document review.
  • Immediate document distribution.
  • Paper-free document management system.
  • Document change requests: submission, processing, and review.
  • Document change approval and distribution.
  • How to handle "Minor" changes.
  • Streamlined document change control process.
  • Change control for design documentation.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that are interested in spending less time on change control. The employees who will benefit include:

  • Executive Management
  • Document Control Management
  • Internal auditors
  • Supplier auditors
  • Consultants
  • Quality system auditors

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
21 CFR Part 11 Compliance for SaaS/Cloud Applications - 80202SEM

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed