Risk Management - Beyond the Numbers

Speaker

Instructor: Roger Greenwald
Product ID: 700624

Location
  • Duration: 60 Min
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.
RECORDED TRAINING
Last Recorded Date: Sep-2007

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$500.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

 

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.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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