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January 01, 2017
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to handle audits and inspections during business expansion.
December 01, 2016
Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.
April 01, 2016
Careful planning, adequate staffing levels, and experienced project managers can help avoid pitfalls of transferring processes from one facility to another.
January 01, 2016
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.
August 01, 2015
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
March 01, 2015
Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.
February 01, 2012
A Risk-Management Case Study.
June 01, 2008
It is important to understand critical aspects of the CMO's capabilities. Only by auditing certain key areas can the sponsor be assured of the quality of the materials produced.
September 02, 2006
SOPs are written job aids that detail the procedure of how to do a specific job task correctly.