Published: April, 2022
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 by 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 CPE webinar will also guide you 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.
Major topics covered in this Online CPE Webinar course on Information Technology:
MY-CPE LLC, 1600 Highway 6 south, suite 250, sugar land, TX, 77478
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Account Executive, BrainStorm Central Consulting LLC
Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, 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.
BrainStorm Central Consulting is the leader and premier catalyst for moving companies to a new level by outstripping conventional wisdom and thought, and creating a strategy that goes beyond the realm of “better, faster, cheaper”.
"Our experience will lead you to us, your experience will keep you coming back..."
FDA Compliance Training Topics Offered:
• Developing a Strategic Approach to FDA Compliance for Computer Systems
• FDA’s Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products
• Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
• Medical Device Industry Trends for Computer Systems Regulated by FDA
• Tobacco and Related Industry Trends for Computer Systems Regulated by FDA
• FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars
• FDA Compliance and Mobile Applications
• Good Documentation Practices to Support FDA Computer System Validation
• In-Depth Computer System Testing of Computer Systems Regulated by FDA
• Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
• Data Integrity and Governance for Computer Systems Regulated by FDA
• Trends in FDA Compliance and Enforcement for Regulated Systems
• Best Practices in Preparation for an FDA Computer System Audit
• Functional System Requirements for Computer Systems Regulated by FDA
• Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
• 21 CFR Part 11 (e-Records/Signatures) Compliance for Computer Systems Regulated by FDA
• C-TPAT Compliance for FDA-Regulated Industries
• Medical Device Cybersecurity and FDA Compliance
• 21st Century Cures Act and Medical Device Software Compliance
• Medical Device Software 62304 Compliance
• Creating, Reviewing & Managing Audit Trails: Compliance for FDA-Regulated Computer Systems
• Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA