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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
Electronic records and
electronic signatures (ER/ES) came into play through guidelines established by
FDA in 1997 and disseminated through 21 CFR Part 11. This code describes the basic requirements
for validating and documenting ER/ES capability in systems used in an
FDA-regulated environment.
In the early 2000s,
FDA recognized they could not inspect every computer system at every regulated
company and placed the onus on industry to begin assessing all regulated
computer systems based on risk. The
level of potential risk, should the system fail to operate properly, needed to
be the basis for each company’s approach to developing a validation approach
and rationale as part of the planning process.
System size, complexity, business criticality, GAMP 5 category, and risk
rating are the five key components for determining the scope and robustness of
testing required to ensure data integrity and product safety.
FDA’s recent focus on
data integrity during computer system validation inspections and audits has
brought this issue to the forefront of importance for compliance of systems
used in regulated industries. These
include all systems that “touch” products, meaning they are used to create,
collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and
unstructured data, including documents, spreadsheets, presentations, images,
audio, and video files, amongst others, must be managed and maintained with
integrity throughout their entire life cycle.
Major areas covered by speaker Carolyn Troiano in this online CPE course:
Click here to access online CPE webinars on Information technology.
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
2 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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