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Pharma companies find ways to maintain quality standards, despite pandemic-related restrictions.
The COVID-19 pandemic has posed serious challenges in pharmaceutical supply chain management and quality assurance and control (QA/QC) at a time when budgets and staffing at many companies have been constrained. Identifying the cultural roots of quality problems challenges pharma’s quality leaders to establish a culture of quality. A growing trend is the use of technology to optimize QA/QC.
An Editors’ Series panel discussion—A “New Normal” for Quality Practices—reviews quality and regulatory challenges amid the pandemic, focusing on new technologies such as remote monitoring, risk-based quality management, Annex 1 changes in the European Union, and lessons learned going forward.
The quality practices panel discussion features commentary from Scott Deckebach, MBA, director of compliance, Lachman Consultant Services, Inc.; Marty Lipa, pharmaceutical regulatory science team member and doctoral student at Technological University Dublin, and executive director of knowledge management at Merck and Co., Inc.; and Siegfried Schmitt PhD, vice-president, Parexel, and Pharmaceutical Technology editorial advisor and columnist.
The discussion, moderated by the editors of Pharmaceutical Technology and BioPharm International, was recorded on Nov. 11, 2020, during the 2020 Bio/Pharma Virtual Congress.