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FDA 483s and Warning Letters list inadequate CAPA practices! What are Medical Device Manufacturers doing about it?

DURHAM, N.C., Oct. 22, 2013 /PRNewswire-iReach/ -- The main goal of Corrective Action and Preventive Action (CAPA) is continuous improvement. CAPA's aim is to collect and analyze information, investigate product, and check the overall quality before taking the necessary action be it corrective or preventive— to avoid non compliance. CAPA practices are one of the common non-compliance issues identified by the auditors. To prevent that, organization must understand the FDA's expectation instead of using the same process over and over again.

CAPA Practices for FDA Regulated Industry: Practical Tips to Meet FDA's Expectations

According to most FDA 483s and Warning Letters, insufficient CAPA practices are the most common findings. Misunderstanding related to FDA's expectations has led to non compliance and excessive cost and labor. Join Dr. Mukesh Kumar in this power packed session, where he will list step-by-step process to assure CAPA practices meet FDA's expectations. He will shed light on previous case studies to highlight common mistakes and ways of avoiding them. In addition, he will provide invaluable tips to create SOPs, management policies, and training methods to withstand an FDA audit. In this informative 60 minute, Dr.Kumar will discuss the regulations, FDA training processes specific to CAPA, and best practices for compliant facilities. Case studies from drugs, biologics and medical device facilities will be used to highlight common errors and acceptable solutions.

Areas covered in the session:

Know the requirements of the CAPA process and procedure

Elements of the CAPA file and their intended purpose

CAPA documentation processes including CAPA plan, SOPs, and written policies

Find out the best practices for CAPA process

Management oversight and monitoring CAPA activities

Case studies on site specific issues

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