This 15-Minute Guide describes the documentation challenges presented to pharmaceutical companies that outsource clinical trials to CROs. It covers industry adoption of the TMF reference model as the basis for electronic trial master files (eTMFs) — and how eTMFs improve document visibility and provide easy, secure access throughout a trial. Learn more.
By Gary Hyde, Senior Product Manager, ProPharma Group
In what for some may be a relatively chaotic run-up to meeting the impending serialization requirements from multiple regulatory authorities, it is critical for serialization project managers to assure implementation falls within the constraints of, and that the resulting serialization process is integrated within, the existing compliant quality systems, including those that govern validation, controlled documentation, investigation, and labeling.
By Jenny Sprung, Product Manager, Labconco Corporation
Typically, sample concentration or solvent evaporation requires heat to drive the evaporation process. For heat-sensitive samples, adding too much heat can damage or modify the structure of the analyte.
By Dale Natoli, Natoli Engineering Company, Inc.
If your business is in the tablet compression industry, then you are most likely using tablet compression tooling of the standard "B" and/or "D" configuration, regardless of the country you are in. Tablet compression tooling is often referred to as tooling, or more commonly, punches and dies.
By Dirk Ahlbrecht, Sartorius Group
The U.S. Pharmacopeial (USP) Convention's Chapter 41 minimum quality standards for weights and balances have been updated after twenty years — and every pharmaceutical manufacturer has been waiting to see what that means in practice when the standards go into effect in December, 2013.
By Brian Garrett, LEED Green Associate, Product Manager
Results of a LinkedIn study suggested that improving the comfort levels of laboratory professionals leads to greater safety in the lab, in Part I of this series of articles. The conversation included anecdotal evidence in further support of this concept. However, there was some interesting commentary spinning off into comfort's effect on productivity.
By Stephen E Szabo, Ph.D., Manager Applications Development, Beckman Coulter, Inc.
Yeast are single-cell microorganisms that reproduce by budding. A well-known property of yeast is that they are responsible for the conversion of fermentable sugars into alcohol and other byproducts.
The Biomanufacturing Summit 2014 attracts senior and executive-level industry professionals working within manufacturing, process development, and product operations. Through a combination of panel discussions, case studies, keynote sessions, interactive workshops, and networking activities, attendees will come to network and exchange knowledge on the latest strategies and technologies available to improve their organizational performance. Learn more.