Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends
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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.
Areas Covered in the Session:
Who Will Benefit:
- 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
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
David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry.
He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM's/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations.
Mr. Dills most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.
He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products.
David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.
He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk.
He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.