The Center for Professional Advancement, Your Computer - An Online Training Format
June 28, 2007
Who Should Attend: This online training will benefit professionals in the following industries: -Medical Device, Pharmaceutical, Human Tissue, BiotechnologyIn departments such as: -QA/QC/RA, Manufacturing/Operations, Research and Development, Legal With job functions: -Department managers and supervisors, QA/QC/RA specialists and engineers, Manufacturing and R&D engineers, chemists, scientists, formulators, documentation specialists, auditors, technicians Description: CAPA systems have come under intense scrutiny by the FDA in recent years. This course will examine the current industry-FDA environment and will give you tools for survival; it will provide a step-by-step guide to the setting-up, operation, management and auditing of a CAPA system for today’s FDA regulated industry environment. Module 1: Background-Regulatory Requirements Why do I need a CAPA System? Why is CAPA the “Heart” of my Quality System? Module 2: What exactly is a CAPA System and what is it supposed to do? What are the Essential Elements of an effective CAPA System? Module 3: How do I implement an effective CAPA System? Why all these records; is there an easier way? How can computer automation help? Course Type: An Online Training Course
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