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Course Level :Basic
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Credits :6
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Instructional Method :Group Internet Based
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Pre-requisites :None
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Advance Preparation :None
Computer
system validation (CSV) is a documented process that is required by regulatory
agencies around the world to verify that a computerized system does exactly
what it is designed to do in a consistent and reproducible manner. These
regulatory agencies require CSV processes to confirm the accuracy and integrity
of data in computerized systems to ensure product safety and effectiveness.
IQ, OQ, PQ
protocols are methods for demonstrating that equipment being used or installed
will offer a high degree of quality assurance such that production processes
will consistently manufacture products that meet quality requirements. Validation
Summary Reports provide an overview of the entire validation project. Once the
summary report is signed, the validation project is considered to be complete.
When validation
projects use multiple testing systems, some organizations will produce a
testing summary report for each test protocol, and then summarize the project
with a final Summary Report. The amount of detail in the reports should reflect
the relative complexity, business use, and regulatory risk of the system. The
report is often structured to mirror the validation plan that initiated the
project.
Following are the major topics covered on Day 2 of this CPE Webinar on Information Technology:
This CPE course is designed to completely immerse you
in computer system validation (CSV). It delivers comprehensive details of the
regulations impacting your systems and hands-on practice writing validation
documents.
During boot
camp, we will explore both a traditional waterfall approach to validation and a
Computer Software Assurance (CSA) approach that is supported by FDA. CSA
focuses on critical thinking and may be done according to an agile methodology,
using automated testing to improve the speed and quality of the validation
effort. We will highlight the key differences and what must be done to succeed
with either of the two methodologies.
We will also
discuss industry best practices and areas of potential confusion and risk. Both
compliance with data integrity and 21 CFR Part 11, FDA’s guidance on electronic
records (ER) and electronic signatures (ES) will be covered.
Boot camp is tough and challenging.
It is a
three-day complete immersion in the validation process. Participants will work
in focused teams to complete hands-on validation activities through
instruction, exercises, and case scenarios.
The course moves quickly and participants will change gears often to
keep interested high and accommodate multiple learning styles. A balance of
instructor lectures, reading materials, exercises, and case studies keeps
energy levels high and challenges the participants.
MY-CPE LLC, 1600 Highway 6 south, suite 250, sugar land, TX, 77478
MY-CPE LLC (Sponsor Id#: GEHNZ) has entered into an agreement with the Internal Revenue Service, to meet the requirements of 31 Code of Federal Regulations, section 10.6(g), covering maintenance of attendance records, retention of program outlines, qualifications of instructors, and length of class hours. This agreement does not constitute an endorsement by the IRS as to the quality of the program or its contribution to the professional competence of the enrolled individual. Credit earned by attendees with a PTIN will be reported directly to the IRS as required of all providers. To ensure your CPE hours are reported, update your profile in My Account to include your PTIN number. Please note: IRS CE is only mandatory for EAs and ERPAs. For all other tax return preparers, CE is voluntary.
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
Mar 30th, 2022
This is a great class and I really appreciate the information. Everything is relevant, and easily transfers to other industries.
6 Credits
Subject Area
Jul 01, 2022 | 10:00 AM EDT
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