Best Practices for Auditing of Vendor of Computer Systems Regulated by FDA
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Speaker : CAROLYN TROIANO
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When : Wednesday, March 22, 2023
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Time : 01 : 00 PM EST
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Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid, and other FDA-regulated industries. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation, and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling and distribution, clinical testing and management, adverse events management, and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing, or managing the implementation of any computer system governed by FDA regulations, or if you are developing, configuring, maintaining, or supporting such a system.
We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration, or similar activity. Computerized systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product, or a raw material or packaging component used in conjunction with the product during the manufacturing, testing, or tracking processes). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.
It is important to be able to identify computer systems used when performing FDA-regulated activities. When a vendor is involved, whether in terms of provisioning hardware and/or software, implementing the system, or maintaining it, this must be done in compliance with FDA requirements. A solid computer system validation strategy, along with an understanding of industry best practices, will lead your company to ensure that vendors are held accountable for the delivery of systems and services that will support your efforts to validate computer systems and maintain them in a validated state.
This webinar will also provide guidance on the importance of factoring risk into all FDA-regulated activities and will help you assess the risk of any computer products purchased from third-party vendors. You will also learn how to develop a standard audit process, using templates and checklists, to ease the burden of this activity. Documentation is critical to proving that a system does what it purports to do and that a company has thoroughly scrutinized and effectively leveraged any third-party vendor that is involved in these efforts.
Learning Objectives
- Vendor Audit
- Vendor Questionnaire
- Audit Procedure
- Audit Checklist
- Leveraging Vendors
- Vendor Management
- FDA GxPs
- Computer System Validation (CSV) Methodology
- System Development Life Cycle (SDLC) Framework
- Risk Management
- GAMP 5
- Compliance Strategy
- Cost vs. Compliance
- Industry Best Practices
- Policies and Procedures
- Training
- Q&A
Course Level - Intermediate
Who Should Attend
Manufacturing, Testing, Packaging, and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:
- Pharmaceutical
- Medical Device
- Biologicals
- Tobacco (based on the Tobacco Control Act of 2009)
- E-Liquid/Vapor (based on the “Deeming” Act of 2016)
- E-Cigarette (based on the “Deeming” Act of 2016) Cigar (based on the “Deeming” Act of 2016)
- Third-Party companies that support those in the above industries
Personnel in the following roles 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
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$179.00
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