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May 31, 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,

	Industry News

MabPlex Announces the Opening of San Diego Process Development CoE

Cloud Pharmaceuticals forms Drug Design Collaboration with GSK

Aldevron Makes Board of Directors Appointment

Teikoku Pharma USA, Link Health Enter into License Agreement for Lidoderm in China

Amneal Announces FDA Approval of Cyclophosphamide for Injection

Centogene Announces Agreement with Aldeyra Therapeutics

	Featured Articles

Top Mistakes in Analytical Method Validation and How to Avoid Them Top Mistakes in Analytical Method Validation and How to Avoid Them Method validation is essential in proving the quality, reliability and consistency of a chemical being developed. Proper validation of a method provides documented evidence of method performance and ... read more »

Technical Transfer to CDMO – Case Study Best Practices for Success Technical Transfer to CDMO – Case Study Best Practices for Success Technical transfer to a contract development and manufacturing organization (CDMO) mobilizes the efforts of a technical team, from start through commercialization activities and throughout the life ... read more »

	Featured Video

Watch Video: Mark Egerton, CEO of Quotient Sciences, Interview at AAPS 2017
Mark Egerton, CEO of Quotient Sciences, Interview at AAPS 2017
Quotient Sciences is dedicated to accelerating the development of new drugs for patients around the world. We provide formulation development, clinical pharmacology trials, and clinical and commercial... read more »

Watch Video: Brandon Zurawlow AMRI Booth Interview at Interphex 2017
Watch Video: Brandon Zurawlow AMRI Booth Interview at Interphex 2017
Albany Molecular Research Inc (AMRI) is a pharmaceutical services organization offering Discovery/Development solutions, and Drug Product and API Manufacturing. read more »

	Featured Whitepaper

How Molded Manifold Assemblies Prevent Leaks and Costly Consequences How Molded Manifold Assemblies Prevent Leaks and Costly Consequences Traditional fluid transfer systems for biopharm and pharmaceutical applications rely on a multitude of complex components to move liquids from one ... read more »

Manufacturing of Cytotoxic and Non-Cytotoxic Drugs in a Multi-Product Facility Manufacturing of Cytotoxic and Non-Cytotoxic Drugs in a Multi-Product Facility Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less ... read more »

	Events

15th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry
San Francisco, CA – 09/09/2018
Join CASSS for the 15th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry on September 9-12, 2018 in San ... event details »

Advancing the Science of Study Endpoints Conference
North Bethesda, MD – 09/20/2018
DIA’s Conference on clinical trial endpoints will bring together key stakeholders to address critical questions and generate potential solutions to ... event details »

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