Date(s) - 01/16/2018
1:00 pm - 2:30 pm
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. In this FDA Compliance Training, you’ll learn all about how to prepare your system validation documentation for an FDA audit of your company’s computer systems.
WHY SHOULD YOU ATTEND
It is not enough just to validate a computer system and defend your approach to regulatory agencies. You will also need to ensure that the data and information collected, analyzed and reported using the system can be defended effectively, as well. In this course, you will learn how to apply industry best practices to ensure that you and your system users and other stakeholders are fully prepared to defend your systems, data and information to regulatory agencies. At the same time, you will learn how to do this in the most cost-effective manner.
- Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
- Validation Strategy that will take into account the system risk assessment process
- Functional Requirements Specification (FRS) to include detailed needs that are described in a specific and unique way
- System Design Specification (SDS) that details how the functional requirements will be delivered
- Test Planning, including Development of Scenarios, Cases and Scripts (Installation Qualification, Operational Qualification and Performance Qualification)
- Requirements Traceability Matrix (RTM) that connects the requirements, design and test elements
- System Acceptance and Release Notification
- System Retirement steps to close out the life cycle
- Data Archival to ensure security, integrity and compliance
- Best Practices for preparing for an FDA computer system audit
- To understand how to prepare computer system validation documentation in preparation for an FDA audit.
- To understand the many deliverables required to complete a computer system validation effort.
- To understand industry best practices.
- To understand and avoid potential pitfalls.
WHO 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
All FDA-regulated industries:
- Medical Device
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.
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