Master the Vendor Auditing of your Computer Systems Regulated by FDA

This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by 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. 

Why You Should 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 FDA.

Areas Covered in the Session :

• 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

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

Course Director: CAROLYN TROIANO ‎

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.