Risk Management - Beyond the Numbers

Instructor: Roger Greenwald
Product ID: 700624
  • 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
Last Recorded Date: Sep-2007

Training CD / USB Drive

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

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This Risk Management webinar/training will describe enhancements to these techniques that can improve your relationships with customers and regulatory agencies, resulting in a reduced number of surprises during inspections.

Many FDA regulated companies utilize numerically based risk management techniques such as FMEA and RPN to determine where to focus their risk mitigation activities. This presentation will describe enhancements to these techniques that can improve your relationships with customers and regulatory agencies, resulting in a reduced number of surprises during inspections. The bottom line is a protection or enhancement of your bottom line and a (correct) perception that you are responsive to the right issues.

Areas Covered in the seminar:

  • What are the FDA and ISO requirements for risk analysis and control?
  • What is a typical pre-release risk management system?
  • What is a typical post-release risk management system?
  • Why are the typical approaches insufficient?
  • How to develop additional criteria for a more comprehensive risk management system
  • Why should you listen to your gut?
  • Real world examples of the preceding principles

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that have risk management systems. The employees who will benefit include:

  • Quality management and personnel
  • QA managers and personnel
  • Engineering and Manufacturing managers
  • Consultants

Instructor Profile:

Roger Greenwald, is a principal of NJK & Associates, Inc., a consulting firm that specializes in Quality and Regulatory Affairs for medical device and IVD manufacturers.He has more than 30 years experience in manufacturing industries, with more than 20 related to medical devices. He has held line and management positions in R&D, manufacturing, and quality, and currently holds 38 US patents for medical, surgical, and consumer devices. His front-line industry experience dealing with customers, complaints, failure investigations, risk analyses, and inspectors bring a real-world perspective to his presentations. He is known for challenging the status quo and helping students toward tangible improvement in their systems.

Follow us :
Critical Vendor Risk Management
Medical Device Summit 2018

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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