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Perform Effective Investigations and CAPAs: Key Steps to Avoid Regulatory Citations
The Corrective and Preventive Action (CAPA) process is the heart of any quality management system. And yet, year after year, CAPA violations are the most frequently observed Quality System subsystem cited by FDA regardless of the manufacturers shape or size.
Susan Schniepp — a Distinguished Fellow at Regulatory Compliance Associates with more than 35 years of experience in quality assurance — will discuss the importance of effective CAPA and investigations management and share best practices for creating effective programs.
Everyone involved in investigations and CAPA resolution in your organization will benefit.
Susan Schniepp has over 35 years’ experience in Quality Assurance, serving in leadership roles at Searle, Abbott, Hospira, Allergy Laboratories and OsoBio Pharmaceuticals. A winner of the Parenteral Drug Assn. (PDA) Distinguished Service Award and Distinguished Author Award, Ms. Schniepp has served on PDA’s Board of Directors and chaired the PDA/FDA Joint Regulatory Affairs Conference as well as the Regulatory Affairs/Quality Advisory Board. Her book Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process won the Distinguished Author Award in 2007 PDA.
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