Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives – Webinar Recording/Transcript
Your products and your compliance — not to mention meeting your business objectives — depend on a healthy quality culture.
Is the typical “I’ll know it when I see it” a helpful metric in identifying what systemically creates, builds, erodes, and/or strengthens a company’s quality culture? Hardly.
But it is possible to apply research-based culture modeling and system dynamics in conjunction with risk management and quality management structures and systems to transform a life science organization’s quality culture and strategically shape it to meet business objectives.
By highlighting the Quality Pulse® behavior model, a research-based quality culture diagnostic assessment for use in life sciences, Teresa Gorecki, practice director, Compliance Architects®, and Kenneth Ray, principal consultant, Kenneth G Ray, LLC, will share how to recognize the behaviors that shape a healthy quality culture, how to diagnose and measure the health of your organization’s and how to take yours — and your products — beyond what you thought possible.
Get a handle on how culture is created, shaped and changed with this persentation, so you can design — and sustain — a good quality culture within your organization.
- The importance quality culture in life sciences as described by the FDA, including the role of quality culture in quality by design (QbD) and Case for Quality (CoQ)
- The research-based behavioral model of quality culture in life sciences, including how employee experiences and beliefs drive behaviors and the reinforcing system dynamics between expressed beliefs, observed behaviors, business systems/structures and underlying culture
- The interdependency of quality culture, quality management systems (QMS), and risk management and how these systems and observed beliefs/behaviors influence effectiveness and desired outcomes
- How to apply this model to measure and diagnose the current quality culture of a life science organization
- An in-depth look at quality culture and risk management, including how to identify specific actions that will influence quality culture toward desired outcomes
This is your opportunity to go beyond basic culture metrics to create and sustain a healthy quality culture going forward.
Meet Your Presenters
Teresa Gorecki, practice director, Compliance Architects®, brings more than 30 years of experience in a variety of leadership roles from Director to Senior Director to Vice President in all areas of quality assurance, quality systems and compliance across biopharma/biotech, pharma and consumer OTCs and devices in the U.S. and Puerto Rico. She has experience in premarketed product and good clinical practice (GCP) quality assurance, plant quality, distribution quality and marketing company quality and compliance globally. She has successfully led countless global health authority and FDA inspections (preapproval inspections, general inspections, “for cause” inspections, team biologics inspections, etc.) and has managed the remediation efforts resulting from serious 483s and/or warning letters. Ms. Gorecki has extensive experience in developing quality systems for small start-up companies and large, global multinational companies. She has curated a unique risk-based approach in the development of quality systems for biopharma start-up companies that is “right sized” and “risk-based” in her practice as a consultant.
Kenneth Ray, principal consultant, Kenneth G Ray, LLC, brings 34 years of experience in multiple leadership roles in quality, compliance and talent/leadership/learning roles across pharma and biotech in a wide variety of contexts. He has led quality operations at a large manufacturing site, led multiple design/build/implement efforts for quality management systems (QMS) at local/global scale, strategic quality policy governance and enterprise-level governance, compliance, remediation and talent/leadership/learning efforts. Mr. Ray’s experience spans multiple mergers/acquisitions, consent decree remediation, size/scale of operations and global/multicultural contexts.
Who Will Benefit
Leaders who determine and/or implement the strategic direction of supply chain, particularly:
- Executive Director/Vice President of Quality
- Executive Director/Vice President of Quality Manufacturing
- Executive Director/Vice President of Quality Technical Services
- Executive Director/Vice President of Site Leadership
- Director/Senior Director of Quality
- Director/Senior Director of Quality Manufacturing
- Director/Senior Director of Quality Technical Services
- Director/Senior Director of Site Leadership
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June 15, 2021