FDA New Draft Guidance on (Software) and Device Changes 510k
Training
Online
*Indicative price
Original amount in USD:
$ 290
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
3h
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Duration
1 Day
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Start date
October
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Virtual classes
Yes
In this webinar FDA provides a flowchart to guide software manufacturers through the process of determining whether a 510(k) must be prepared, and also you will be able to determine how to manage software and device changes in an FDA-compliant manner.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Medical
- Medical training
- Online Trainings
- Compliance education
- Industrial courses
- Technical courses
- Fda inspections
- Knowledge
- Financial updates
- Compliance Trainings
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 includes any major change or modification to the intended use of the device that could have an impact on patient safety and effectiveness. After attending this webinar, you will be able to better navigate the processes required to determine how to manage software and device changes in an FDA-compliant manner.
Areas Covered in the Session:Medical Device changesSoftware Application changes for software used in conjunction with medical devicesFDA Guidance DocumentsFDA EnforcementNew 510(k) submissionSubstantial Equivalence
Who Will Benefit:Information Technology (IT) AnalystsIT DevelopersIT Support StaffQC/QA Managers and AnalystsClinical Data Managers and ScientistsAnalytical ChemistsQuality Managers, Chemists and MicrobiologistsCompliance Managers and AuditorsLab Managers and 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. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
Event Fee: One Dial-in One Attendee Price: US $290.00
Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
Additional information
FDA New Draft Guidance on (Software) and Device Changes 510k
*Indicative price
Original amount in USD:
$ 290