Learn the methodology, recommend tools, and establish the basis for documentation.
Learn disciplined methodology to achieve optimal results in as little time as possible while simultaneously ensuring robust documentation meeting the stringent requirements highly regulated industries demand. Problem-solving techniques are leveraged from Six Sigma, 8D, Kaizen, DMAIC, TQM, and others. Technical root cause: the change that occurred, resulting in performance decline. Systemic root cause: failures that allowed the change to occur. Corrective and preventive actions: restore performance to previous levels or requirements. Control plan: monitor and prevent a recurrence. You will receive a copy of the presentation slides, an Investigation Roadmap, and a set of electronic templates that will guide you through the methodology, recommend tools, and establish the basis for documentation.
Agenda
Faculty
Rob Weaver
Weaver Consulting
- President, Weaver Consulting
- Global client base encompasses a multitude of highly regulated industries, including pharmaceutical, medical device, aerospace & defense, automotive, food & beverage, financial services, semiconductor, and more
- Customers include highly recognizable organizations such as Google, Boeing, Johnson & Johnson, Citibank, Northrup Grumman, Federal Aviation Administration (FAA), Food & Drug Administration (FDA), Medtronic, and Apple
- Weaver Consulting has been a featured speaker with the Food and Drug Administration (FDA), American Society of Quality, Regulatory Affairs Professionals Society, Food Safety Consortium, Food Safety Tech, Parenteral Drug Association, Sparta Connection (TrackWise), Medical Device & Manufacturing, Center for Professional Advancement, and Medtech
- Published or interviewed with American Pharmaceutical Review and Medtech Insight (The Gray Sheet)
- B.A. degree in business management, St. Mary’s University
- Can be contacted at [email protected] or 612-720-7918
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