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Vendor Audit for Systems and Services for FDA-Regulated Systems
- Developing a strategic approach to vendor audit
- Understanding best industry audit practices to ensure FDA compliance
- Identifying the key areas of vendor performance that are necessary to ensure they will meet your compliance requirements
- Knowing the right questions to ask about an array of key areas that could have an impact on security and validation
- Understanding how to investigate 21 CFR Part 11 (electronic records/electronic signatures) compliance
- Understanding how a vendor will provide the customer service and support required to run your critical business operations
- Identifying the procedural controls needed to support areas where there may be technical control gaps or weaknesses
- Determining how to monitor the vendor over time, performing audits through questionnaires or on-site visits
- Understanding ways to leverage your vendor’s experience and expertise to assist with Installation Qualification and Operational Qualification
- Understand how to assess a vendor’s ability to provide custom code, testing assistance, and training to your team
- Learn how to carefully document all activities related to your vendor to ensure compliance
Overview of the webinar
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by the FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, requirements, code development/management practices, version control, change control, compliance with 21 CFR Part 11 (electronic records/electronic signatures), testing, operations management, disaster recovery, document management, and customer service. A template and checklist are provided for use in conducting vendor audits. These will help guide you through the process and ensure you fully assess the vendor’s capability.
Who should attend?
- 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
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance, and audit
- Computer System Validation Specialists
- GMP Training Specialists
- Consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance
- Auditors engaged in the internal inspection
Why should you attend?
Effective and compliant computer system development, testing, and validation are critical to any pharmaceutical or FDA-regulated organization. You should attend this seminar if you are responsible for planning, executing or managing a computer system that is governed by FDA regulations. A full understanding of how to assess the vendor’s practices is essential to ensuring compliance and is a first step in the validation of a computer system regulated by the FDA.
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.