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Computer
system validation has been regulated by FDA for more than 30 years, as it
relates to systems used in the manufacturing, testing, and distribution of a
product in the pharmaceutical, biotechnology, medical device, or other
FDA-regulated industries. The FDA requirements ensure thorough planning,
implementation, integration, testing, and management of computer systems used
to collect, analyze and/or report data.
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.
In December 2018,
FDA issued a guidance document on Data Integrity (DI), which has seen an
alarming increase in DI issues during inspection of regulated firms. This
upward trend continues and is of particular interest during FDA inspection.
In this
CPE webinar, we will explore good Documentation Practices to Support FDA Computer System
Validation.
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.
Duration
Course Level
Instructional Method
Pre-requisites
Advance Preparation
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.
1.5 Credits
Add to WatchlistThis course is set to be rescheduled shortly. Please fill out the short form below, and we'll let you know as soon as the course becomes available
1. How can I earn Continuing Education credits for live webinars?
A: To earn credits, you must register for the webcast before it begins. Attend the entire live webinar and respond to polling questions if supported.
2. When will I receive my Continuing Education Credit Certificate?
A: You'll receive your certificate within 24 hours after each webinar.
3. What's the basis for credit issuance?
A: Credits are issued on a 50-minute credit hour basis.
4. What if I can't use the polling feature on a web browser?
A: The polling feature is only supported on the Zoom desktop and mobile app. You can provide responses in the chat if needed.
5. Are these live events or recordings?
A: Some events may be recorded, but instructors will be available for questions during/after the webinar.
6. Do myCPE courses meet professional standards?
A: Yes, myCPE meets global Continuing Professional Development (CPD-IES7) standards for various accounting and financial professions. Confirm with your licensing organization if needed.
7. Where can I manage my certificates and credits?
A: You can manage them through your certificate dashboard when logged into your account.
8. Is myCPE accredited for Continuing Professional Education in the United States?
A: Yes, myCPE is accredited by various professional organizations, making it suitable for fulfilling continuing education requirements.
9. Who can take myCPE courses?
A: myCPE courses are suitable for professionals with 100+ designations, including CPAs, CMAs, CFAs, and more.
10. What's the refund and complaint resolution policy?
A: To learn about the refund and complaint resolution policy, click here for details.
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