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June 07, 2018
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   Internal Audits and FDA Inspections

With a flurry of new guidance from FDA and other global regulations, it is critical to benchmark against the best in order to ensure you remain in a GMP compliant state and implement innovative processes that ensure continuous improvement. At Internal Audits and FDA Inspections, hear industry leaders doing just that,

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» Industry News
 
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» Featured Articles
Value of Natural History Studies Throughout the Product Life Cycle
Value of Natural History Studies Throughout the Product Life Cycle
An in-depth understanding of the disease or condition for which a drug or biologic is being developed is an important component of drug development. However, in some situations, the detail about the... read more »
CRO’s FSP Model Proves to be the Right Choice
CRO’s FSP Model Proves to be the Right Choice
The current pharmaceutical and clinical research environment is in a constant state of change. Business decisions resulting in mergers, acquisitions and resource depletion, coupled with increasing ... read more »
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» Featured Video
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  Watch Video: Halo Pharma's Full-Service Facility in Whippany, New Jersey
Watch Video: Halo Pharma's Full-Service Facility in Whippany, New Jersey
Glenn Herring, Vice President of Halo Pharma, and Anthony Que, Vice President of Product Development at Halo Pharma talk about their facility in Whippany, New Jersey and its fully integrated, cutting ... read more »
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  Watch Video: Interview with Michele Luche from AMRI at AAPS 2016
Watch Video: Interview with Michele Luche from AMRI at AAPS 2016
AMRI is a trusted partner for global contract research, testing and manufacturing services for the biopharmaceutical industry. Our specialized solutions include Drug Discovery, such as medicinal ... read more »

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» Featured Whitepaper
An Untapped Source for Risk-Based Monitoring
An Untapped Source for Risk-Based Monitoring
Applied effectively, today’s sophisticated IRTs can enable study teams to augment their risk-based monitoring strategy with additional proactive ... read more »
Tips for a well-design product development plan and commercial product success
Tips for a well-design product development plan and commercial product success
In product development for proteins, mAbs, and ADCs, it’s common for the phase 1 and final commercial product presentation to be undetermined. Liquid,... read more »
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| Events
EVENT
  PREP 2018
Baltimore, MD –  07/08/2018
The 31st International Symposium, Workshops, and Exposition on Preparative and Process Chromatography will focus on the development, design, ... event details »
EVENT
  CMC Strategy Forum North America: “Next Generation” Biotechnology Product Development, Manufacturing and Control Strategies
Gaithersburg, MD –  07/16/2018
Join CASSS for the CMC Strategy Forum North America on July 16-17, 2018 at the Gaithersburg Marriott Hotel, Gaithersburg, MD. At this CMC Strategy ... event details »
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