Old Problems, New Solutions

	October 10, 2023			October 11, 2023					October 10, 2023	October 11, 2023
	Continual Improvement & Metrics	Innovation & Tools	Leadership & Customer Focus	Continual Improvement & Metrics	Innovation & Tools	Leadership & Customer Focus			RAPS Regulatory 101	RAPS Regulatory 201
	Room 101-B	Room 101-C	Room 101-D	Room 101-B	Room 101-C	Room 101-D			Room 101-E	Room 101-E
	Discover strategies and concepts for evaluating, analyzing, and driving ongoing quality system refinement.	Learn about creative approaches and practices for enhancing the quality of products, services, and processes.	Explore the art of guiding and influencing organizations to best meet the expectations of interested parties.	Discover strategies and concepts for evaluating, analyzing, and driving ongoing quality system refinement.	Learn about creative approaches and practices for enhancing the quality of products, services, and processes.	Explore the art of guiding and influencing organizations to best meet the expectations of interested parties.			Achieve a fundamental understanding of the regulations, an overview of international regulations, and pathways to putting a medical device on the U.S. market.	Extend understanding of medical device regulations and pathways with more specific topics and get answers directly from someone from the U.S. FDA!
8:00	Registration			Registration
9:00-10:15	Session 1			Session 1				9:00-9:45	Session 1	Session 1
	Scenario Building with Monte Carlo Analysis Andrew Beeson	Auditing Process Validations – What to Look For Teresa Cherry	Unlocking Growth and Workforce Wellbeing Rolf Biernath	Third Party Audit Preparation Jorge Lopez	The Innovation Formula – An Old Book with Fresh Ideas Dave McFarland	Don’t Fear the Auditor Michelle Jirak			Medical Device Regulations Overview Jackie Torfin	Advertising & Promotional Practices Aaron Hage
								9:45-10:30	Session 2	Session 2
									Quality Systems Overview Steve Gompertz	FDA Q-Submission Lisa Pritchard
10:15-10:30	Break / Networking							10:30-10:45	Break / Networking
10:30-11:45	Session 2			Session 2				10:45-11:45	Session 3	Session 3
	Just Move the Process Jessica Zeirke	Statistical Insights with Graphs of Individual Data Values Karen Hulting	Interview, Job Review, Then What? Jon Linn / David Bruce	Statistics, Risk, and Cognitive Biases Jeremy Nichols	Driving AIML Medical Devices Success Through Culture of Quality Kamala Nanjundeshaiah	A Dynamic Leadership Approach Francois Kammoe			U.S. FDA 510(k) & De Novo Submissions Kathy Herzog	Clinical Trials & Investigational Device Exemptions (IDEs) Joy Frestedt
11:45-1:00	Lunch							11:45-1:00	Lunch
1:00-1:45	Keynote							1:00-1:45	Keynote
1:45-2:45	Session 3			Session 3				1:45-2:45	Session 4	Session 4
	Problems with Problems – How Can we Get Better? Teresa Cherry	Error Proofing Humans Paul Hylenski	Best Practices for Achieving Software Reliability Michelle Jirak	10 Common Mistakes in a Supplier Auditing Program Kory Randall	FMEA-Lite Gary Jing	Establishing an Excellence from Anywhere Culture Scott Moeller			U.S. FDA Pre-Market Approvals Mac McKeen	Risk Management & Post-Market Vigilance Mark Swanson
2:45-3:00	Break / Networking							2:45-3:00	Break / Networking
3:00-4:00	Session 4			Session 4				3:00-4:00	Session 5	Session 5
	Deploying DOE to Identify Vital Factors that Affect Quality Mark Anderson	A New Perspective on Fundamental Quality Tools Edward Jaeck	Enhancing Horizontal Interaction for System Improvement Dr. Charles A. Liedtke	Gear-Up for Sailing the CSA Uncertainty Ricardo Torres-Rivera	Human Centered Design and Medical Devices Tom KraMer	Unlocking Success: The Power of ASQ Membership Helen Swanson			Introduction to EU/International Regulations Kristen Evenson	Working with the U.S. FDA Rhonda Mecl
4:00-5:00	Booth Bar Crawl			Networking				4:00-5:00	Booth Bar Crawl
5:00-6:30	Welcome Reception – Expo Hall							5:00-6:30	Welcome Reception