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

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

Ways to Limit Your HIPAA Vulnerability and Liability - Webinar

 

Conference - Online

Although there are many presentations, courses and services now available to help health care organizations to become HIPAA compliant, the real issue for the health care organization is to determine the most cost effective ways to understand their risks and to minimize the vulnerability to a breach and their liability when a breach does occur.

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Tags: 2014, Medicine, August, Healthcare, Webinar, Conference

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

2-day In-person Seminar on HIPAA: Basics, BA's, Training & International: Many Challenges, Many Questions & Many Answers

 

Conference - Online

2-day In-person Seminar on HIPAA: Basics, BA's, Training and International: Many Challenges, Many Questions and Many Answers Overview: We will start the event with a look back at HIPAA. Often times, the basics get overlooked or forgotten, often at the expense of increasing risks of a breach.

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Tags: 2014, Medicine, August, Healthcare, Webinar, Seminar, Conference

How to Properly Handle HIPAA Security Incidents & Actual Breaches

 

Conference - Online

The word "breach" in the health care industry, and for those business associates of covered entities, certainly causes alarm when not only have you had your patient's privacy violated, but also now you have to prepare for the financial cost to remedy the breach and think about the possible criminal and civil penalties that you or your organization may have to face.

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Tags: 2014, Medicine, August, Healthcare, Webinar, Conference, Event

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