Quantitative Approach to User Requirements Risk Assessment

Instructor: Vimarie Ortiz
Product ID: 700390
Training Level: Intermediate
  • 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: May-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 training offers a quantitative risk management approach you can use to measure system implementation and enhancement efforts against the criticality and business/regulatory significance of the system.

Can we balance the efforts of system implementation and validation against the benefits of having the system? Of course we can! But, what tools can we use?

A practice that is recommended by the FDA and industry guidances is risk management. When risk management is applied to user requirements it allows us to develop and control our system implementations, validation, and maintenance based on the benefits we seek and our responsibility towards data integrity, product quality and safety.

This Web Seminar offers a quantitative risk management approach you can use to measure system implementation and enhancement efforts against the criticality and business/regulatory significance of the system. It draws from FMEA, GAMP and ISO risk management guidelines, and provides quantifiable results to help your decision making.

Areas Covered in the seminar:

  • The importance of user requirements numbering and categorization (Principles of requirements management)
  • Disseminating the user requirements gathering responsibilities (Cross-functional teams) How to develop an FMEA/GAMP-based risk assessment suited to the company’s risks
  • The importance of risk mitigation practices
  • Matching risk levels with system selection, development and validation

Who Will Benefit:

  • Validation Teams
  • Software Developers
  • Information Management
  • Project Management
  • Compliance and Regulatory Management
  • Regulatory Management
  • Quality System Auditors
  • Training Department
  • Consultants

Instructor Profile:

Vimarie Ortiz is a principal with Processo Partners, Inc., a consulting compliance technologies company in South Florida specializing in all aspects of Computer Systems Validation.

Ms. Ortiz’s experience in the medical devices/pharmaceutical industry spans a decade, assisting clients in the management, implementation and training of all aspects of computerized systems validation, and the design of validation methodologies using risk-based and configuration management approaches.

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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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