Technology Introduces a New Normal for Quality Practices

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.