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.

Course Objectives:

• 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

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.

Course Outline:

• Best industry audit practices to ensure FDA compliance
• Specific review of how to assess:
• Vendor organization
• Vendor capability/ skills assessment
• Physical/logical security practices
• Requirements definition
• Code development/management practices
• Version control practices
• Change control practices
• Compliance with 21 CFR Part 11 (electronic records/electronic signatures)
• Testing approach
• Operations management
• Disaster recovery program
• Document management practices
• Customer service

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Quality Managers, Chemists and Microbiologists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences