Published: May, 2022
FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how Disaster Recovery and Business Continuity Planning should be carried out.
This is necessary to protect against the onslaught of threats and attacks, both from natural disasters and as a result of cyber-warfare.
In this CPE webinar, the attendee will learn how to develop a standard approach to planning, executing, and documenting efforts that involve the recovery of systems and data in a manner that complies with FDA guidelines. Some people may be new to the concept of validation and FDA regulation and will have to be coached on how to follow any necessary procedures required for compliance.
This is often true for IT staff and is likely to be the case in companies in the Tobacco industry, where regulations are emerging. It’s important to look at what are some of the threats and challenges, and what methods you can use to mitigate these. There is an enormous body of documentation and information available that can be overwhelming.
This CPE Information technology course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective techniques and tools available to assure compliance when managing activities related to handling data.
MY-CPE LLC, 1600 Highway 6 south, suite 250, sugar land, TX, 77478
MY-CPE LLC (Sponsor Id#: 143597) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.NASBARegistry.org.
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