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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
This CPE
Webinar will focus on testing as a key element of Computer System Validation
(CSV).
The level of testing must reflect both the
potential risk associated with the failure of the system to function properly.
It must also be based on the systems’ classification in accordance with GAMP 5
and on a thorough risk assessment of what could happen if the system were to
fail. A standard risk approach will be explained to incorporate into the
testing to be done.
With the help of this CPE course, you
will learn the way to develop a detailed rationale for testing and how to
ensure that it is fully executed and documented in accordance with FDA
requirements.
You
will also be provided with guidance for maintaining the system in a validated
state and assessing the level of any testing that might be required
post-validation to ensure that compliance.
We
will address all three phases of CSV testing, including Installation
Qualification (IQ), Operational Qualification (OQ), and Performance
Qualification (PQ). Each phase has specific requirements and the approach taken
is critical in terms of the resources and time required.
In this CPE course, we will also discuss ways to minimize costs while assuring maximum compliance with FDA requirements for CSV.
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
1 Ratings
1.5 Credits
Subject Area
Jul 05, 2022 | 09:00 AM EDT
Jul 05, 2022 | 09:30 AM EDT
Jul 05, 2022 | 09:30 AM EDT
Jul 05, 2022 | 10:00 AM EDT
Jul 05, 2022 | 10:00 AM EDT
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