Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: David R. Dills

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.

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

SPEAKER PROFILE:
David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness.

He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company’s commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing.

He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, 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 and 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 validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.