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

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

Global Compliance Trainings 's Designing Accelerated Life Testing

 

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

CAPA Training & Causes of Warning Letters due to Lack of Comprehension

 

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.

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Tags: 2014, Michigan, United States, Webinar, May, pharmaceutical, Life Sciences, Conference, MI, Biotech current events

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

GCP/ICH Obligations of Sponsors, Monitors, & Investigators: How to guarantee a clean inspection/audit

 

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.

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Tags: 2014, Michigan, United States, Webinar, May, clinical trials, Clinical Research, Life Sciences, Conference, MI

Orphan drug regulation, value add IP? Better than Patents

 

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.

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

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

Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach

 

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,

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

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