CAPA Cool: A Risk-Based Approach:
Are you interested in closing Corrective and Preventive Actions (CAPAs) in less time, leaving more time to focus on improvements and problem-solving? A risk-focused CAPA framework will transform the way you think. Stop the insanity of a traditional resource-draining one-size-fits-all CAPA method.
Championing a Culture of Quality:
Continuous improvement leads to higher-quality devices, greater organizational efficiencies, and investment returns. Hear from quality leaders on the importance and challenges of elevating organization culture to one of Quality excellence from a variety of perspectives. The discussion will explore various challenges facing professionals and companies that directly impact elevating quality culture to the next level offering personal insights with successful best practices.
Join onsite:
-
Jackie Torfin, CEO QLeaR Advisors
-
Paul Sumner, Program Director, Case for Quality, the Medical Device Innovation Consortium (MDIC)
-
Karen Peifer, Principal Quality System Software Engineer, Silk Road Medical
This session is intended to help you think of different ways to address and implement risk-based thinking and a culture of quality within your organization.
Who Should Attend: Anyone interested in the opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across your total product lifecycle.
When: Tuesday, October 29th 9:00 am - 2:00 PM CST
Check In starts at 8:45 am, lunch will be provided
Where: St. Cloud State - Plymouth 9750 Rockford Road, Suite #100, Plymouth MN
NOTE: This is a live, onsite event.
Cost:
Certificates of Completion: Issued via email, after event completion, for .4 ASQ RUs or .4 CEUs
If you have any special requests or questions, please contact Karen Peifer at kpeifer@memberleader.asq.org.
Your Speakers:
Jackie Torfin, CEO QLeaR Advisors. Jackie Torfin has been a leader in MedTech and Biotech companies for 30+ years. She has had roles in quality, regulatory, project management, pre-clinical and clinical research/compliance. She has a BS in Medical Technology and a Master's in Leadership. She has been Adjunct Faculty for 10+ years at St. Cloud University in the Master's in Medical Technology Quality and Regulatory Science Programs with responsibility for Corrective Action and Preventive Action, Supplier Management, Design Verification and Validation, as well as Quality Management Systems curriculum authoring. She is CEO and Principal Advisor at QLeaR Advisors, a consulting firm focused on quality and regulatory compliance for MedTech and Biotech companies with a passion for mentoring and coaching others. She focuses on due diligence, and remediation activities, Compliance Leadership mentoring/coaching, and is a Certified Quality Auditor with ASQ, certified GMP and Lead ISO auditor.
Paul Sumner, Program Director, Case for Quality, the Medical Device Innovation Consortium (MDIC). Paul Sumner serves as Program Director for the MDIC Case for Quality. Paul has a wealth of experience in medical devices, quality assurance, strategic regulatory affairs, compliance, security, and privacy matters. Paul previously served in compliance and regulatory leadership roles at Change HealthCare (formerly McKesson Technology Solutions) and has worked for a range of medical device companies throughout his career. He founded and led a PACS company as President and CEO and established international clientele from many years of independent consultancy. An accomplished presenter, Paul has delivered numerous company and client trainings in ISO 13485, ISO 9001, ICH E6 GCP, 21 CFR 812 IDE, 21 CFR 820 QMS, EU and Canadian medical device regulations, among other topics.
Karen Peifer, Silk Road Medical, Principal Quality System Software Engineer is a leader in non-product software validation with over 24 years of experience with 14 years in a regulated environment. Her career includes validation of online trading systems, automated systems in manufacturing, spreadsheet validation, ERP, electronic quality records, automating Study data capture, and the pharmaceuticals realm. Karen is currently at Silk Road Medical, where she is implementing a risk-based validation program for Quality System software and automated systems in manufacturing. It is great when people have that ah-ha moment; realizing that there is less pain in the validation and change process than they thought. That being creative still equals quality and compliance. Problem solving not only for today, but also looking at how it affects the future, is looking at a systematic approach to quality.