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

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

Workshop on Techniques in Modeling Human Cancer in Mice (2015)

 

Workshop - Bar Harbor, ME, United States

It has become increasingly clear that the laboratory mouse, the best genetically defined experimental model organism for humans, presents a major opportunity for rapid advancement in understanding the genetic basis and underlying biology of cancer.

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Tags: research mice, cancer research, Cancer, Workshop, US, May, ME, Bar Harbor, 2015, Life Sciences, laboratory, Mice, lab research, research laboratories

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

Contract Manufacturing FDA Guidance – What is new? Will it impact other outsourcing activities?

 

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”.

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

Testing For Safety, Reliability, And Durability

 

Conference - Online

Usual inspection and testing is highly inadequate for product validation.

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

What is the FDA position on the Responsibilities of the Principle Investigator while Conducting Premarket Clinical Research?

 

Conference - Online

With the increasing surveillance / auditing by the investigative wing of the FDA / OHRP it behooves Physician and dentist Investigators to become familiar and knowledgeable regarding their responsibilities.

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

Developing a Post-Approval Risk Management Strategy

 

Conference - Online

We will discuss how Risk Management Files are developed and maintained in accordance with ISO 14971 throughout the product lifecycle.

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

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