Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends

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. Learn some of the new practices being used on how to conduct the CAPA investigation and the use these tools.

Areas Covered in the seminar:

• How to use FMEA effectively and calculating Risk Priority Numbers: How to Use the Criteria?
• Learn how to use and how far to go with an effective and efficient approach for your CAPA investigation.
• 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.

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
• QA/QC/Compliance/Regulatory Affairs
• Marketing & Sales
• Engineering/Technical Services
• Consultants
• Operations and Manufacturing

Instructor Profile:

David R. Dills, is Senior Consultant with PAREXEL Consulting in January 2007.Prior to joining the consultancy Mr. Dills has provided independent consulting on technical and regulatory affairs and compliance to pharmaceutical, Class I, II, and III medical device, and biologics/biotech companies with an emphasis on establishing sustainable compliance and validation environments. Mr. Dills also served as Director of Publications, Regulatory & Compliance for the Institute of Validation Technology. Through his work, Mr. Dills has been affiliated within the FDA-regulated industry for more than nineteen years in the areas of QA, Quality Engineering, Validation, Regulatory Affairs/Compliance, and Corporate/Operations Management and employed on behalf of well-known, globally recognized manufacturers and service providers.

Mr. Dills areas of interest and expertise include, but not limited to, deploying and implementing validation programs, supplier/vendor qualification, Quality Systems, customized training, auditing, QMS policy and procedure development/implementation from cradle to grave, project management, risk management/assessment/risk-based tools and techniques, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, conducting Gap Assessments and Remediation/CAP activities, GxPs, Computer and Software Validation/IT Network, Part 11, change control, use of quality/statistical tools and techniques, design controls, CAPA, all aspects of regulatory submissions, including PMA, IDE, 501(k), NDA and e-CTD/CMCs for Agency approval, working with international groups/regulations, FDA Mock and PAI Inspections, PDMA/sample accountability, and other related functions and tasks.

Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He serves on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. Mr. Dills has authored and published numerous validation and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.

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