CAPA (Corrective and preventative actions)

Schedule:

• 23 September 2008, 1:00 pm Eastern

Duration: 2 hours with questions and answers

Synopsis: The most frequently issued USFDA 483/Notified Body non-conformance is for an inadequate or poorly managed corrective/preventive action process. This webinar will help you understand why most companies fail to continually improve and provide insight on how you can make your CAPA process your most valuable management tool with great ideas on:

• Identifying CAPA sources
• Monitoring trends/metrics
• Evaluating data
• Identifying root cause
• Implementing change
• Monitoring effectiveness
• Post Market Surveillance/Vigilance, and
• Gaining regulator’s confidence

Description: There really is great value to be realized from continually improving your product and processes. Never waste time and money again with the un-necessary or doing something over. In fact, even your competition can be a great source of valuable information. Avoid the costs associated with lost opportunities. In football it is called momentum, we call it continuous improvement and the focal point is your CAPA process… put it to work for you.

Who should attend: This webinar is ideal for regulatory/quality management staff, research and development teams, production managers and executives of all types.

Presenter: Tim Duggins, Horizon Phoenix’s Senior Partner has more than 25 years experience in medical device quality systems and product testing. Tim is a skilled and fully accredited consultant and auditor with extensive experience implementing fully compliant regulatory and quality systems using EN/ISO 13485, USFDA QSR, Health Canada CMDR and/or all medical European Directives for more than 100 clients. An avidly sought after expert, he served as a consultant to such diverse organizations as federal governments, international non-governmental organizations, and industry from multi-national manufacturers to a three-person niche-market company. Tim has participated on numerous national and international committees writing product testing standards and helping create government regulatory processes; his product experience spans the entire medical device spectrum from high volume injection molded disposable products, digital radiography systems, in vitro diagnostic test kits to implantable cardiovascular devices.

Expert contributor: TBA

Registration: $295

Registration for this event will be set up soon...

Please Email Us and let us know of your interest in this webinar and we will make sure you are notified immediately when the online registration opens for this event. (Please make sure you note the Webinar and date you are inquiring about in your email)

www.horizonphoenix.biz

www.raqawebinars.com

For more information or to pose a question about this webinar contact: info@raqawebinars.com (Please make sure you note the Webinar and date you are inquiring about in your email)