Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in pharmaceuticals, government and biotech industries, in domestic and international regulatory affairs and clinical research.
Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in pharmaceuticals, government and biotech industries, in domestic and international regulatory affairs and clinical research.
KR Karu is an industry solutions director at Sparta Systems. He manages relationships with a wide range of pharmaceutical customers, helping them track and better understand ongoing regulatory changes and trends in the industry.
Warren joined Qumas in 2003 and his career in the Regulated arena spans over 20 years. He was previously with CDC Solutions for over 3 years, and before that spent 18 years in Content and Records Management on the West Coast of the US. For the past 8 years he has specialized in Part 11 compliance.
Description
Corrective and Preventive Action (CAPA) have become an integral part of a GCP Quality Management System approach. A formal program for CAPA is becoming an integral means for meeting FDA and global regulatory expectations for clinical trial quality. The relationship between documentation, deviations and corrective actions is becoming more clear with each 483 letter issued by the FDA. The ability to effectively manage your SOPs, track training and associate them to CAPA resolution is vital.
Learning Objectives: Recognize CAPA systems can be managed and leveraged to support site inspections Define clear metrics for the success of GCP/GLP reporting automation Identify development of effective training programs to deal with issues.