Risk-Based Approach to Computerized Systems Validation (CSV) has been a challenging concept to implement since the topic was introduced through GAMP5 in 2008. This vital fundamental activity is considered by Health Authorities to be the only acceptable way of meeting regulatory requirements in a way that is compliant and cost-effective.
At this point, majority of industry players have adapted some theoretical frameworks that define at high level what needs to be done, but fail to govern the actual framework implementation and explain how computerized systems validation should be adjusted according to scientifically measured system risks. This leads to uncertain levels of compliance, misplaced efforts, and uncontrollable costs.
The problems introduced by inadequate Risk-Based Approach to validation are countless, and include:
- Inability to determine what regulatory requirements apply to a system
- Lack of clarity about what exactly needs to be done for the system to be considered validated
- Validation projects that are clearly over-burdensome, taking too long and costing too much
- Inadequately tested important system functions, while testing focuses too much on unimportant functions
Areas Covered in the Session :
Based on a wealth of real-life experience and laced with real-life examples, this course builds on GAMP5 dogmas to define practical steps to Risk-Based Approach to Validation. It specifically focuses on:
- Defining and controlling overall system validation scope and costs through System Risk Assessments; and
- Defining and controlling the level of system testing through Functional Risk Assessments
- Interactive Q&A Session
Who Should Attend:
This course will be of benefit to anyone involved in any aspects of computerized systems compliance, computerized systems validation, and regulated GxP data management. A must attend webinar for the following departments:
- Quality Assurance
- Regulatory Affairs
- Research & Development
- Quality Control
Course Director: PAUL LABAS
Paul Labas serves as Director of IT Compliance and CSV practice at IPS – Integrated Project Services, a life sciences industry consulting firm headquartered in Blue Bell, PA. Mr. Labas offers over 15 years of experience and expertise in all aspects of Computerized and Automated Systems Compliance, Computerized Systems Validation and Electronic Data Integrity.
Paul’s diverse experience includes high-risk projects such as establishment of organizational compliance frameworks, responses to consent decrees, and validation of systems in use by more than 100,000 people worldwide. Mr. Labas is involved on numerous ISPE initiatives, including formal peer reviews and authorship of industry guidance documents.