Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries

Why Should You Attend:

The Lean Six Sigma methodology is emerging as not only the best practice in successfully addressing CAPA opportunities but also quality in general. Organizations, the likes of Abbott, GlaxoSmithKline, GE Healthcare, Sandoz, and Bayer, just to name a few, have been leveraging Lean Six Sigma to improve quality and performance across their value chain. What is more is that these large players expect their suppliers too to have proven, repeatable and effective quality systems in place.

This webinar will provide an overview of the Lean Six Sigma methodology, followed by the detailed review of a corrective action initiative. It will take the attendees through the five phases of LSS, helping demonstrate the problem solving approach. The presenter will discuss industry case studies to demonstrate the use of the LSS process to successfully close CAPA activities.

Areas Covered in the Webinar:

• Overview of Lean Six Sigma (LSS) Methodology
• How LSS fits into the CAPA & Risk Management framework
• Specific deliverables in the following problem solving/investigation phases:
1. Define – what is the problem, from the customers’ perspective? Has the process boundaries of the problem been defined?
2. Measure – What is the most effective way for us to measure the problem? How does the process(s) with the largest impact to the non-conformance work today? What is best way to collect process/product data needed for root cause investigation?
3. Analyze – How well does our process perform in relation to customer expectations? What are the key sources to the non-conformance?
4. Improve – based on the identified root causes, what are the optimal “implementable” solutions? Solutions need piloting or full implementation? Were the desired results attained?
5. Control – With the process now in control, how do we best measure “in-process” performance? How do we sustain the improvements long term?
• Industry case studies detailing the usage of the LSS process to successfully close CAPA activities.

Who will Benefit:

This webinar will provide valuable assistance to all personnel with responsibility for:

• Complaint Investigations
• CAPA
• QA/QC
• Engineering
• Manufacturing
• Process Development
• Compliance (Regulatory Affairs staff who consult on complaint investigations and communication to FDA and other regulatory bodies)
• Internal audits

Instructor Profile:

Dr. Ray Bandziulis, has over two decades experience as a quality and regulatory professional in progressively responsible quality systems, R&D management, and business development roles in the biotechnology and in vitro diagnostic industries. He has the demonstrated ability to implement and maintain compliant quality management systems in both rapid growth research and manufacturing environments and mature commercial businesses. Ray’s special expertise is in managing new product development portfolios, design transfer, supplier qualification and agreements, management reviews, complaint handling processes, and CAPA. Ray was a principal architect in building a successful custom biotechnology manufacturing business unit serving the molecular diagnostics market. Through the deployment of strategic quality approaches with key clients, he helped grow this unit to >$30M annual revenues over an eight year period.

Ray earned his Ph.D. in cell and molecular biology at Yale University in New Haven, Connecticut, and he did his undergraduate work and post-graduate research at Northwestern University in Evanston, Illinois. He served as director of quality systems at Exact Sciences and director of corporate quality assurance and regulatory affairs at Promega Corporation, both in Madison, Wisconsin.

Shahbaz Shahbazi, was a leader in GE Healthcare’s Global Lean Six Sigma Quality organization focused on strategic business growth, prior to launching ProcessArc. As an expatriate based in Paris, France, he reformulated a sales and pricing strategy for a $250 million market and streamlined the commercial launch of new products. He has also led global customer satisfaction initiatives. As the cofounder of ProcessArc, he has helped institutions like Third Wave Technologies, Exact Science, Integra Life, RW Baird, BETA systems, US Bank, and Metavante launch Lean Six Sigma in their respective organizations. In his career he has trained and mentored over 120 Lean Six Sigma Green Belts and Black Belts globally. Shahbaz has authored over 40 strategy reports on product development and operational efficiency. He has received professional education in Transactional Lean Methodology, CAP, Import/Export Practices, and GE’s Leadership Essentials.

Shahbaz holds an MBA from Rensselaer Polytechnic Institute, a master’s in public policy from the University at Albany, and BAs in French literature and Middle Eastern history from the College at Oneonta, State University of New York. He is GE Lean Six Sigma Green Belt, Black Belt and Master Black Belt certified.

Topic Background:

The complaint management process is a critical listening post for a company to hear and understand their customers' experiences with their products. When executed properly, complaint investigations provide input for new or improved product designs or processes and identify new opportunities to expand market share with existing products. In many medical device or biotechnology companies, however, complaint handling hinges on the participation of production or research staff whose primary responsibilities and training may not include product, process, or CAPA investigations. The Lean Six Sigma methodology offers a standardized approach for regulated life science companies to follow whenever investigations are needed.

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