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Mastering the HIPAA Privacy, Security, and Breach Notification...

Eventos anteriores Cuota: 1295.00 - 1495 USD Visualizaciones: 2753

Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently,...

Using Statistical Methods for ICH Guidelines: 2-day...

Eventos anteriores Cuota: 1295.00 - 1495 USD Visualizaciones: 3659

Overview: This hands-on course will provide attendees with an understanding of how to apply statistical methods to the ICH Q series guidelines. The course will...

How to Prepare and Submit a Bullet Proof 510(k) and...

Eventos anteriores Cuota: 1295.00 - 1495.00 USD Visualizaciones: 2673

Overview: This Two-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to...

2-day In-person Seminar on “Software Validation for...

Eventos anteriores Cuota: 1595.00 - 1795.00 USD Visualizaciones: 2700

Overview: 1. This course will teach you how to reduce software validation costs by as much as two thirds. 2. It details all the requirements for 21 CFR Part 11...

2-day In-person Seminar on Why is FDA at my Facility,...

Eventos anteriores Cuota: 1295.00 - 1495 USD Visualizaciones: 2675

Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions....

Applying ISO14971 and IEC62304 - A guide to practical...

Eventos anteriores Cuota: 1295.00 - 1495 USD Visualizaciones: 3898

Overview: This seminar covers the compliance issues relating to ISO 14971, IEC 62304 and IEC60601-1:2005. Especially the cross-standard and practical means to integrate...

The DHF, Technical File and Design Dossier - Similarities,...

Eventos anteriores Cuota: 1295.00 USD Visualizaciones: 4231

Overview: One of our most popular subjects, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must...

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