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.
The complimentary live presentation begins at 11:00 a.m. (EDT) on Tuesday, October 31. To attend, register here or visit www.pilgrimquality.com/about-pilgrim/events.
About Pilgrim Quality Solutions
Pilgrim Quality Solutions is the leader in quality compliance management software and services for Life Sciences. For more than 20 years, our solutions have automated thousands of processes across global company sites to manage the quality and compliance of life’s most important products. Our cloud-based and on-premise solutions include in-the-box best practice workflows, document and process management, dashboards, electronic signatures, audit trails, and automated validation – helping companies more easily achieve quality system compliance and pass regulatory audits. With Pilgrim Quality Solutions as your partner, you are prepared to succeed. For more information, visit www.pilgrimquality.com.