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Course Level :Basic
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Credits :1.5
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Instructional Method :Group Internet Based
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Pre-requisites :None
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Advance Preparation :None
Effective and
compliant computer system validation is critical to any FDA-regulated
organization. During the past 30 years,
best practices have been developed and, if followed, can ensure laboratory
computer systems are validated efficiently and in compliance with FDA
regulations. This CPE webinar will
provide guidance for planning, executing, and validating a laboratory computer
system, and managing the system in a validated state through the end of the
system life cycle.
The CPE course will
address roles and responsibilities, the timing of phases and deliverables, business
process reengineering, organizational change management, change control, audit trails, training, and documentation.
You will learn what is required not only to validate your laboratory system but maintain it in a validated state until it is retired or otherwise no longer
in use.
There is an enormous
body of documentation and information available on computer system validation,
which can be overwhelming. This continuing
education 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 methods, techniques, and tools available.
Major areas covered in this online CPE course:
Click here for more Information on technology webinars
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
3 Ratings
1.5 Credits
Subject Area
Jun 29, 2022 | 09:30 AM EDT
Jun 29, 2022 | 10:00 AM EDT
Jun 29, 2022 | 10:00 AM EDT
Jun 29, 2022 | 10:00 AM EDT
Jun 29, 2022 | 10:00 AM EDT
Jun 29, 2022 | 10:00 AM EDT
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