Pilgrim Quality Solutions to Address Pharmaceutical Implications of CDER Metrics and Reporting
Tampa, FL — October 23, 2017 — Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services for the Life Sciences, today announced it will present a live webcast later this month for pharmaceutical organizations on the implications of participating in the Food and Drug Administration’s (FDA) Quality Metrics reporting program.
The webinar, Solutions for CDER Metrics and Reporting, on October 31, 2017, will be co-presented by Cynthia Lambert, Regulatory Specialist at Pilgrim Quality Solutions, and Pilgrim Industry Solutions Group Manager Joshua Center. They will discuss how a risk-based, data-driven approach to future compliance and inspection practices will be key to ongoing compliance and success when the FDA Center for Drug Evaluation and Research (CDER) Metrics program launches early next year.
According to the FDA, “Quality metrics are used throughout the drugs and biologics industry to monitor quality control systems and processes and drive the continuous improvement efforts in drug manufacturing.” The agency advises pharmaceutical organizations to implement a strong risk management process, and to be able to produce metrics that expose and manage risk. Those actions will influence how it develops compliance and inspections policies and practices going forward.
At present, the Quality Metrics reporting program is voluntary, however, Ms. Lambert states, “Pharmaceutical manufacturers would be well advised to become more familiar with the program, and begin to develop new standard operating procedures (SOPs) and identify the right quality management system (QMS) solutions in order to be ready for the formal launch.”
Pilgrim’s webinar will address CDER Quality Metric’s latest guidance, the resulting benefits to the pharmaceutical industry and its patients, a breakdown of each of the metrics, and the potential challenges and approaches to implementation of metrics reporting across various segments of the pharmaceutical industry.