This 60 minute webinar will help you understand the basics of corrective actions and preventive actions (CAPAs) and how to initiate, handle, monitor, and manage them. You will also learn the purpose and scope of medical device CAPAs, when to initiate and not to initiate CAPAs, best CAPA practices, the similarities and differences between FDA and Notified Body CAPA requirements and what is expected when an external auditing body examines your CAPA procedures and documentation.
Why should you Attend?
Most industry personnel are overwhelmed by national and international quality system laws, directives, regulations, standards and guidance documents. As such, they believe if they obtain quality system certification from an European Notified Body that they will automatically pass an FDA audit. However, this is not the case especially in the area of CAPAs. FDA warning letter after Warning Letter prove otherwise…True that Europe’s quality management system standard (ISO 13485) and U.S.A’s quality system regulation (21 CFR Part 820) are very similar in nature; however, your CAPA system is viewed totally different by the FDA than by the European Union. Not only is it required under law to have CAPA procedures and records, FDA requires you to also have a sound CAPA system; whereas the Notified Bodies do not. If top management do not initiate an effective CAPA system, not only may regulatory compliance sanctions against the company occur, but the company may also loose its competitive advantage, have customer lawsuits, perform unnecessary recalls, and be known as a company with non-quality products and services.
This Webinar will provide valuable assistance to all medical device companies in developing a sound CAPA system, initiating, handling, monitoring managing and maintaining CAPAs, and when to initiate and not initiate CAPAs. The focus will be a basic understanding of quality system CAPAs without confusing everyone with regulatory compliance jargon. The webinar will include the following:
Who will benefit?
This topic applies to personnel / companies in the medical device industry. The employees who will benefit most include:
However, if you are already familiar with the CAPA process you may recommend this webinar to anyone in your company that has questions about the CAPA process.
Mr. Calafactor has over 21 years of FDA / governmental experience also as an analyst and level II certified international medical device investigator and over 7 years of industrial experience as a biologic, pharmaceutical, and medical device industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor. George not only has inspected, investigated, and audited all types of US and foreign food, cosmetic, drug, biologic, medical device, and clinical
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