Overview
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 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 FDA.
Webinar Takeaway
- 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 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
- 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
Faculty Carolyn Troiano
Midlothian, Virginia, United States
Award winning FDA Compliance Speaker for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity
My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.
My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.
