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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
March 02, 2017
Policies limiting imports and immigration generate uncertainty for US and foreign firms
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.
A survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
A robust quality agreement and good communication scheme can help avoid and alleviate regulatory concerns.
The DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.
The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.
Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.
As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.
Efforts to harmonize the fragmented regulatory framework for pharmaceuticals in the European Union continue to be a challenge.
March 01, 2017
President Trump calls for faster FDA approvals and lower drug prices.