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GlobalCompliancePanel, Online Training, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
2013-12-03
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.
Industry is now using various risk-based approaches and tools to set-up, deploy and maintain their CAPA programs to help with the decision making process. Understand the emphasis on analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems...and the use of appropriate statistical methodology where necessary to detect recurring quality problems. This session provides an overview on identifying recommended practices to improve, streamline, refine, retool…and develop, deploy and maintain a viable and sustainable CAPA system. Learn that a well written policy and procedure on setting up and maintaining your system is just the first part of the process…now you need to monitor your system because CAPA is your immune system and will determine how healthy or unhealthy or business site is. Learn some of the new practices being used on how to conduct the CAPA investigation and the use these tools.
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:This webinar will provide valuable assistance and guidance to all regulated companies that are preparing to use or are currently using risk-based tools for CAPA investigations and closing out investigations in a timely manner. The employees who will benefit include: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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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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David R. 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 experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO. Since 2000, has provided consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting audits and assessments and preparing CAP/remediation plan; compliance engineering support, regulatory planning; post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing.
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Deadline for Abstracts:
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2013-12-03
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Registration:
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Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
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E-mail:
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support@globalcompliancepanel.com
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