Science Researcher Update: Spotlight on Meetings, Conferences, and Events

Writing Good Device Specifications - Recorded Webinar

 

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

FDA & Overview of ISO 13485 - Global Compliance Trainings' Webinar

 

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

Medical Device Quality Management Systems Conference

 

Conference - Atlanta, GA, United States

Across the medical device industry, from corporations preparing to launch a first product, to those with thousands of products being manufactured across disparate global sites, executives are constantly working to update, maintain and evolve quality systems to ensure the rigorous quality assurance required for medical technologies.

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Tags: 2014, USA, September, Development, Quality Control, Life Sciences, Conference, Atlanta, GA

US FDA 510(k): How to Put Together a Compelling 510(k): Good Practices with Increased Awareness

 

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

Elements of a Pharmaceutical GMP Training System

 

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

Using Root Cause Analysis & CAPA for Conducting Effective Investigations of Atypical & Out of Specification Laboratory Results

 

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

FDA Guidance for Contract Manufacturing Arrangements for Drugs: Quality Agreements

 

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

Analytical Method Development, Validation & Transfer

 

Conference - Berlin, Germany

Informa life Sciences Analytical Method Development, Validation and Transfer is a dedicated forum focusing solely on new method development, validation and transfer for pharmaceutical and generics manufacturers.

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Tags: 2014, September, germany, Development, Quality Control, Chemical Sciences, Chemistry, Berlin, Health Science, Conference

Lifecycle Approach to Analytical Methods: Incorporating QbD Principles into Method Development, Validation & Transfer

 

Webinar - Online

This course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including some elements aligned with QbD concepts.

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Tags: 2014, Michigan, United States, August, Webinar, Development, Quality Control, Life Sciences, Conference, MI, laboratory

Webinar on FDA's “483” – Inspectional Observations

 

Conference - Online

At the end of FDA’s establishment inspection, the investigator makes “observations” of instances where it appears the firm does not conform to a regulatory requirement.

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Tags: 2014, Michigan, United States, Webinar, May, Quality Control, Life Sciences, Conference, MI

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