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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