Webinar - Online
This webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection.
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Tags: 2014, Michigan, United States, Webinar, May, Quality Control, Life Sciences, Conference, MI
Conference
Preventing device recalls requires thoroughly predicting what can go wrong proactively using the risk analysis tools. Then it requires revising the specification to accommodate the mitigations for the identified failure modes and harm scenarios.
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Tags: 2014, Medical Device Technology, Michigan, United States, Healthcare, Webinar, May, Quality Control, Life Sciences, Conference, MI
Webinar - Online
This webinar is intended to help you get familiar with US quality system regulations and how to implement an FDA-compliant quality management system for medical devices including in vitro diagnostic medical devices (IVDs).
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Tags: 2014, Medical Device Technology, Michigan, United States, Webinar, May, Quality Control, Life Sciences, Conference, MI
Webinar - Online
Product recalls in 2013 were 28% higher than 2012, and are historically at the highest level. The number one cause is the poor and incomplete specifications.
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Tags: 2014, Michigan, United States, Webinar, May, Quality Control, Life Sciences, Conference, MI
Webinar - Online
This webinar is intended to help you get familiar with FDA’s implementation of statutory requirements for setting risk-based FDA inspectional priorities.
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Tags: 2014, Michigan, United States, Webinar, May, Quality Control, Life Sciences, Conference, MI
Webinar - Online
This webinar is intended to demonstrate how to put together a compelling (bullet proof) 510(k) in compliance with the FDA’s eCopy and RTA policy so that your time, energy and financial resources can be effectively used to expedite your 510(k) clearance, potentially leading to saving millions.
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Tags: 2014, Michigan, United States, Webinar, May, Quality Control, Life Sciences, Conference, MI
Webinar - Online
This webinar will review the foundational requirements and strategies for the creation or enhancement of a GMP training system that contributes to employee quality performance.
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Tags: 2014, Michigan, United States, Webinar, May, Quality Control, pharmaceutical, Life Sciences, Conference, MI
Webinar - Online
This webinar focuses on the use of Root Cause Analysis, Corrective and Preventive Action to address the investigation of Out of Specification (OOS) or atypical results, in the context of the procedures recommended by the FDA OOS Investigation Guidance, to complete investigations more quickly and effectively.
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Tags: 2014, Michigan, United States, Webinar, May, Quality Control, Life Sciences, Conference, MI, laboratory
Webinar - Online
This webinar will describe all of the requirements/suggestions included in this Guidance Document and show what preparation is advisable and how to get there.
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Tags: 2014, Michigan, United States, Webinar, May, Quality Control, pharmaceutical, Life Sciences, Conference, MI
Webinar - Online
Accelerated life testing is the process of testing a product by subjecting it to conditions (such as temperature cycling, stress, strain, random vibration, temperatures etc.)
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Tags: 2014, Michigan, United States, Webinar, May, Life Sciences, Conference, MI
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