Quantitative Approach to User Requirements Risk Assessment
Instructor:
Vimarie Ortiz
Product ID: 700390
Training Level: Intermediate
- Duration: 60 Min
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
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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