Maintaining an effective capa program and using risk assessment

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Live Webinar Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends Date: Wed, December 17, 2014 Instructor:David Dills

Time: 10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes

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Location: Online

Overview: CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.

Areas covered in the session: How to use FMEA effectively and calculating Risk Priority Numbers: How to Use the Criteria How to facilitate a product complaint investigation as part of your CAPA program What is a closed-loop investigation…cradle to grave approach How to conduct an investigation using a well-written CAPA policy and procedure Understand and comprehend what FDA is looking for in meeting minimum expectations…no band-aid solutions Why risk assessment and risk-based approaches, FMEA, FTA, HACCP, etc., are now the expectation in terms of good business practice Establish a priority system as related to major versus minor or high risk versus low risk classifications…to support your decisions Develop and deploy escalation rules and criteria to facilitate decision-making process Understand what it takes to conduct a “quality” investigation to ascertain the root cause Review and discuss recent CAPA red flags and FDA enforcement actions

Who Will Benefit: All levels of Management for all departments and those who desire a better understanding or a "refresh" overview QA/QC/CAPA Coordinators/CAPA Specialists Regulatory Affairs and Compliance Engineering/Technical Services/Operations Consultants

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About Speaker David Dills Regulatory Affairs and Compliance Consultant, David Dills Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of

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