Events Tagged "fda"

Obtaining & Marketing your 510(K) with Today's FDA

How do you obtain a 510(k) in today's environment at FDA? How do you position your 510(k) submission? How do you fashion the intended use statement and argue the technological characteristics.

Clear as Mud: Obtaining & Marketing your 510(K)

An interactive workshop to ensure you understand how to obtain a 510(k) in today's environment at FDA.

FDA Warning Letter - Consent Software Validation

This FDA warning letter will discuss what to do to avoid additional software related compliance along with the response steps where the citations that directly or indirectly include automated system.

The 510(k) Submission: Requirements and Options

This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly.

DHF, DMR, DHR, and the Technical File

This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR.

(2 days)

Validation and 21 CFR Part 11 Compliance

Validation and 21 CFR Part 11 Compliance of Computer Systems - India Seminar 2012 at Bangalore

(2 days)

Validation and 21 CFR Part 11 Compliance

Validation and 21 CFR Part 11 Compliance of Computer Systems - India Seminar 2012 at Delhi

(2 days)

Validation and 21 CFR Part 11 Compliance

Validation and 21 CFR Part 11 Compliance of Computer Systems - India Seminar 2012 at Delhi

(2 days)

Validation and 21 CFR Part 11 Compliance

Validation and 21 CFR Part 11 Compliance of Computer Systems - US Seminar 2012 at San Francisco

Efficient Computer System Validation

Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel

Show all events →

Download events tagged fda in XML or iCalendar format.