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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.
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.
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.)
Tags: 2014, Michigan, United States, Webinar, May, Life Sciences, Conference, MI
Webinar - Online
CAPA (Corrective and Preventative Actions) did not originate in the Pharmaceutical and Medical Device industry or the Automobile Industry as most folks post on the Internet.
Tags: 2014, Michigan, United States, Webinar, May, pharmaceutical, Life Sciences, Conference, MI, Biotech current events
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.
Tags: 2014, Michigan, United States, August, Webinar, Development, Quality Control, Life Sciences, Conference, MI, laboratory
Webinar - Online
This webinar addresses the obligations of sponsors, monitors, and investigators who conduct and verify clinical research that is governed by US FDA regulations and ICH guidelines.
Tags: 2014, Michigan, United States, Webinar, May, clinical trials, Clinical Research, Life Sciences, Conference, MI
Webinar - Online
we will look through the orphan drug regulations in the USA and EU, we will go through these very similar regulatory areas and look at the orphan opportunities in other parts of the world.
Tags: 2014, Michigan, United States, Webinar, May, Life Sciences, Conference, MI
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.
Tags: 2014, Michigan, United States, Webinar, May, Quality Control, Life Sciences, Conference, MI
Conference - Online
Different microorganisms in different environments during sterilization have different resistance to the destructive principles that causes the organism or spore to die (lethality) Some extreme thermophile organisms have their optimal growth temperature at 110°C,
Tags: 2014, Michigan, United States, Webinar, May, Pharmacy, Life Sciences, Conference, MI
Conference - Online
The new FDA Draft Guidance entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements” focuses on the documented and agreed upon responsibilities of the “Owner” and the “Contracted Facility”.
Tags: 2014, Michigan, United States, Webinar, May, Quality Control, Life Sciences, Conference, MI
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