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Validity : 18th Apr'24 to 28th Apr'24
Most Common Problems in Computer System Validation (CSV) and Compliance
The following topics will be covered:
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
- Validation Planning
- Risk Assessment
- GAMP 5 System Categorization
- Functional Requirements
- IQ, OQ and PQ Testing
- User Acceptance
- Maintaining a System in a Validated State
- Policies and Procedures
- Training
- Organizational Readiness
- Documentation
- Q&A
Overview of the webinar
This seminar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations.This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.
We will discuss the phases within the SDLC, and how these form the basis for any CSV project.The importance of the sequence of steps will also be covered.
Who should attend?
- Information Technology Managers, Developers and Analysts
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Compliance Managers
- Lab Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Auditors and Audit Managers
- Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit
- Consultants working in the life sciences industry who are involved in computer system implementation,validation and compliance
Why should you attend?
- Learn how to reduce the time and labor involved in a computer system validation effort by adequately planning your project
- Learn how to leverage past validation efforts to optimize results
- Learn how to ensure your team members are adequately trained to implement and maintain an FDA-regulated computer system in order to manage a successful outcome
- Learn how efficient and effective testing can ensure that all deficiencies are captured before a system is put into production, allowing for a smooth go-live without delay
- Learn how to keep on top of changes to the system over time to ensure it is maintained in a validated state and does not require a complete revalidation due to neglect
- Learn how to manage organizational change at the outset of a new system implementation project in order to avoid sabotage and other attempts to resist new ways of conducting business
- Learn how to evaluate business processes to ensure that these are optimized as the system is being developed and/or configured to enable improvements in efficiency and effectiveness of operations that will save money in the longer run
- Learn how to document all validation work in order to ensure that revisits to the deliverables during subsequent system changes are efficient and do not require extra labor to dig through poorly documented information
- Learn about potential pitfalls to the validation process through real industry examples
- Learn how to avoid and/or mitigate potential pitfalls during the validation process
Faculty - Ms.Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.