webinar trainings - mdpharmacourses · 2017-05-21 · webinar & trainings by highly ... fda...
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MDPHARMACOURSES.com
Is the platform that strengthens your preparation
and skills in the life science field.
Webinar & Trainings By highly experienced Subject Matter
Experts (SMEs) from Pharma and
Medical Device industry.
Regulatory, Quality and
Compliance are very
challenging fields where
continuous improvement
of competence
knowledges and skills
makes the difference.
www.mdpharmacourses.com – [email protected]
FDA & EU Regulations
Quality System
Process Validation
Design Control
R&D and Technical
FDA REGISTRATION: MEDICAL DEVICES IVD, COMBINATION PRODUCTS
Course Description: This Webinar course will introduce you to the FDA Regulation for Medical Device, IVD and Combinations products:
• Device Classification • Class I Medical Device • Class I device exemptions • Class II Medical Device • Investigational Device Exemption (IDE) • Class III Medical Device • PMA Application Contents • PMA filing • Reclassification • In vitro Diagnostics (IVD) – Basics • Combination Product
Links and reference to FDA support material and guidelines are also provided during the presentation.
GO TO THE COURSE
www.mdpharmacourses.com – [email protected]
Who Will Benefit: • Regulatory Affairs specialist • Medical Affairs specialist • Clinical Affair specialist • R&D Engineers • Quality Engineers • Marketing
Availability: Right Now (Recorded Presentation) Duration: 50 min. (the average time to complete the training program).
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www.mdpharmacourses.com – [email protected]
Certification Requirements: Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.
Certificate will be printable in PDF format immediately after satisfying requirements.
Online Training Programs Include: • 90 days of 24/7 access to individual eLearning courses. • Answer to questions submitted during the Webinar. • An online final assessment with multiple-choice questions. • A Certificate of Completion.
FDA REGISTRATION: MEDICAL DEVICES IVD, COMBINATION PRODUCTS
GO TO THE COURSE
Why Should You Attend: The Food and Drug Administration (FDA) was founded in 1906 to better manage the public health of the United States with respect to goods and services. The manufacturer’s FDA registration number is required for all companies producing, distributing or selling goods in the nation. Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE). This Webinar will provide necessary tools to orient in this critical process.
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