This webinar 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. We will focus on how to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do and ensure 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, along with the importance of the sequence of steps and deliverables.
Areas Covered in the Webinar:
- Learn how to reduce the time and labor involved in a computer system validation effort by adequately planning your project
- Learn how to leverage GAMP 5 and the risk assessment approach to validate your systems in a streamlined manner
- 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
Who Will Benefit:
- Industry best practices related to compliance and computer system validation
- Strategies for reducing the cost and complexity of compliance with FDA regulations
- Understanding how the System Development Life Cycle (SDLC) methodology supports the computer system validation process
- Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, thus minimizing both
- Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
- Learn how to gain information about trends in validation, as industry progresses and new best practices emerge
- Understand some of the key “pitfalls” to avoid when applying the SDLC methodology
Personnel in the following roles from industries such as Pharmaceutical, Medical Device, Biologicals, Tobacco, E-Liquid/Vapor, E-Cigarette, Cigar, Contract Research Organizations (CROs) will benefit:
- Information Technology Analysts
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in the internal inspection of labeling records and practices
ERP Project Manager, City of Richmond
Carolyn Troiano has more than 30 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
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. FDATrainingAlert 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.
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