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

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The new FDA Draft Guidance entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements” focuses on the documented and agreed upon responsibilities of the “Owner” and the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

10th Annual OPEX and Quality in Pharma and Biotech

 

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

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

Good Documentation Practices for the Laboratory

 

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 on Using Regulatory Master Files for Investigational Products

 

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

Root Cause Analysis vs. CAUSAL Analysis; What are the Benefits?

 

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

Barriers to Thorough Investigations & Effective Corrective Action(s)/Preventive Action(s) (CAPAs)

 

Conference - Online

Learn why traditional approaches to root cause analyses too often lead to ineffective CAPAs.

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

Determine Appropriate Field Reporting Processes for Medical Device Corrections & Removals

 

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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