Impact Of Strategic Outsourcing On QA Oversight By Sponsor Companies
Recently, we have been observing a change in the approach to outsourcing — more midsize and large biopharmaceutical companies are shifting to a strategic outsourcing model. Strategic outsourcing generally means assigning work to one or a maximum of two preferred (strategic) partners.
WHITE PAPERS & CASE STUDIES
Don’t Get Blindsided By New USP Quality Standards
The U.S. Pharmacopeial Convention’s (USP’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 Dirk Ahlbrecht, Sartorius Group
Points To Consider When Developing A TMF (Trial Master File) Strategy
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). By Karen Redding, Global Business Development Director, Phlexglobal Ltd.
5 Steps To A Reliable CAPA Process
It sounds simple, but lack of CAPA process documentation is a frequent reason for FDA 483 citations. Planning and organization lay the foundation for a strong CAPA program.
Mitigating Risk To Compliance With Integrated Quality Systems
The North American company in this white paper is a global leader in the field of filtration, separation and purification processing equipment for the pharmaceutical, biotech and industrial markets.
Improve Accuracy And Efficiency In Data Collection For Mental-Health Evaluations And Assessments
MedAvante is a global provider of centralized, expert psychological rating services to the pharmaceutical, biotechnology, and medical device industries.
Selecting, Implementing, And Using FDA Compliance Software Solutions
We begin by asking the question, “Is the Quality Management Software market evolving to be easier, or more complex?”