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The new FDA Draft Guidance entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements” focuses on the documented and agreed upon responsibilities of the “Owner” and the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”.
Science Researcher Update: Spotlight on Meetings, Conferences, and Events
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Tags: 2014, Michigan, United States, Webinar, May, Quality Control, Life Sciences, Conference, MI
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
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
Conference - Berlin, Germany
With the heavy pursuit of life sciences continuing to grow by regulators, it is imperative to be prepared to endure a possible investigation.
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Tags: 2014, germany, Quality Control, October, Berlin, Conference, biotech, Biotech current events
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
Conference - Online
According to the FDA, if it isn’t written down, it didn’t happen. As well, if it isn’t written down clearly, it didn’t happen either. GMP compliance requires the use of good documentation practices (GDP).
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Tags: 2014, Michigan, United States, Webinar, May, Quality Control, pharmaceutical, Life Sciences, Conference, MI, laboratory
Webinar - Online
A description of the various stages and sections of a Master Regulatory File (MRF) System. As an investigational product progresses through development key studies, decisions, regulatory communications, manufacturing progression are accumulated and necessary to reference as the NDA and MAA applications are made.
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Tags: 2014, Michigan, United States, Webinar, May, Quality Control, clinical trials, Life Sciences, Conference, MI
Conference - Online
Root Cause Analysis doesn’t provide a complete analysis for a deviation, which hampers the ability to determine effective CAPA and track data for adverse trends of all causes to deviations.
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Conference - Online
Learn why traditional approaches to root cause analyses too often lead to ineffective CAPAs.
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Conference - Online
A review of the relevant sections of the Food, Drug and Cosmetic Act and sections of 21 CFR that FDA utilizes to regulate either the initiation and/or reporting of Medical Device Corrections and Removals, and an overview of status of SG2(PD)/N111R9 guidance document in process to address global harmonization
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Tags: 2014, Medical Device Technology, Michigan, United States, Webinar, May, Quality Control, Life Sciences, Conference, MI
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