Sponsored Webcast: How to be a VIP with FDA: A Panel

In this panel discussion you will learn how to accelerate the quality culture of your organization through continuous improvement initiatives. Hear case studies and perspectives from current industry “VIPs” – participants in the Voluntary Improvement Program - and collaborators in the Case for Quality collaborative community including the FDA, MDIC and ISACA as we cover a range of topics including: 

- Improving relationships with FDA while also learning from fellow VIPs
- Sharing data and success stories from VIPs
- Evaluating work against a proven set of best practices to identify opportunities for improvement, and providing a pathway to guide the improvement journey.
- Prioritizing systemic, holistic, and long-term solutions aligned with business objectives
- Tracking progress over time and against industry while receiving guidance from expert consultants.

We encourage this session to be interactive! Please bring one of your organization’s pain points and we can discuss how it could be addressed, or pose questions to the panel to be answered live

Registration Fees & Deadlines

Free

Learning Objective

• Describe how the Voluntary Improvement Program (VIP) supports the relationship between the FDA and the industry
• See the ROI of shifting from a mindset focused on compliance to one of continuous improvement
• Share how industry peers implement continuous improvement through VIP

Audience Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Who Should Attend?

Leaders and those in roles associated with Quality, Quality Assurance, Quality Systems, Regulatory, Regulatory Affairs, and Compliance

Speakers

Kim Kaplan
Senior Product Manager, ISACA

Kim Kaplan is a Senior Product Manager at ISACA and has been a key collaborator on the Case for Quality Voluntary Improvement Program since the development of its pilot in 2017. She is a certified CMMI Associate and Appraisal Team Member for VIP and now sits as a standing advisor on the VIP Governing Committee. Kim led ISACA’s 2022 launch of the VIP Portal, a new data management tool to help program stakeholders track individual continuous improvement journeys as well as identify broader industry trends and insights.

Lynn Penn
President, Performance and Methods Consulting, LLC

Lynn consults with organizations, focusing on enhancing, institutionalizing, and optimizing business operations. As Director at Lockheed Martin Corporation, Information Systems & Global Solutions, Lynn oversaw policies and process command media, process compliance via audits, and process improvement activities. She is currently a lead appraiser with the Medical Device Discovery Appraisal Program. Lynn has a BS in mathematics from Villanova University, she has done graduate studies in computer science and management information systems. She is a certified ISO 9000 internal auditor at Lockheed Martin. She is also a Certified Greenbelt and Blackbelt in Six Sigma and Lean Techniques. She has published a book “CMMI and Six Sigma: Partners in Process Improvement”.

Paul Sumner
Program Director, Case for Quality, Medical Device Innovation Consortium (MDIC)

Paul Sumner serves as Program Director for the MDIC Case for Quality. He 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 various 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. Paul earned his BBA from Georgia State University, majoring in computer information systems, and is an active member in multiple industry-wide trade associations along with local governmental affairs.

Erin Keith
Senior Advisor, Compliance and Quality Program, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA

Lee Simanski
Principal Quality System Engineer, Boston Scientific

Lee Simanski is a Principal Quality Systems Engineer with Boston Scientific. He has more than 30 years in the Medical Device Industry, is an ASQ Certified Quality Auditor and a Certified CMMI Associate. Lee has participated as an Internal Appraisal Team Member on 18 CMMI Appraisals across multiple sites enrolled in VIP.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email RAPS@raps.org