Best Practices to Support FDA Computer System Validation
Training
Online
*Indicative price
Original amount in USD:
$ 150
Description
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Type
Training
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Level
Advanced
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Methodology
Online
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Class hours
2h
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Duration
1 Day
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Start date
Different dates available
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Virtual classes
Yes
This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection, also this webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails, you will learn how to create and maintain good documentation that meets FDA compliance standards.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Compliance
- Health Management
- Management
- Education Studies
- Quality
- Healthcare
- Technology
- Medical
- Organizational Skills
- Clinical Trial
- Knowledge management
Teachers and trainers (1)
Adam Fleming
Event Manager
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements.
Course programme
Why should you Attend:This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection. There are specific requirements that must be followed in order for the Agency to consider the documentation valid, and without following these, there is a great risk of invalidating work.
Areas Covered in the Session:21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)Data Archival to ensure security, integrity and complianceLearn the requirements for documenting efforts related to systems governed by FDADiscuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
Who Will Benefit:Information Technology AnalystsInformation Technology Developers and TestersQC/QA Managers and AnalystsAnalytical ChemistsLaboratory ManagersAutomation Analysts
Speaker Profile: Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
Additional information
Best Practices to Support FDA Computer System Validation
*Indicative price
Original amount in USD:
$ 150