The QMSR Power Session delivers compliance education through an interactive format designed for quality assurance professionals, regulatory affairs specialists, and medical device developers. This evening program combines expert presentations from seasoned practitioners with hands-on case study analysis and audience participation.
The session opens with personal compliance journeys from industry experts Fran DeGrazio and Mindy McCann, sharing real-world implementation challenges, lessons learned, and practical insights into regulatory innovation. The interactive case study segment features "The Anatomy of a QMSR Compliance Journey."
The expert panel discussion addresses critical topics including purchasing controls, supplier relationships, and strategies for turning regulatory requirements into competitive advantages. Attendees engage in open Q&A sessions targeting their specific compliance challenges.
This program serves quality professionals across experience levels - from QMSR veterans seeking advanced insights to newcomers requiring foundational knowledge. The content applies to medical device and combination product developers, manufacturing managers, compliance officers, consultants, entrepreneurs, and cross-functional team members working with regulatory processes.
Pre-read materials include QMSR regulation documentation and ISO 13485 standards. The practical focus emphasizes real-world application through case-based learning, providing actionable tools for immediate implementation. Networking opportunities complement educational content, connecting attendees with regulatory professionals and industry peers.
Registration Fees & Deadlines
Member $10 | Nonmember $15 | Student Member $5 |Student Nonmember: $5 (With Promo Code)
*Please reach out to a RAPS Philadelphia Chapter Leader to request a Student Promo Code
Agenda
- 6:30-7:00 PM: Registration, networking, and refreshments
- 7:00-8:30 PM: Interactive presentations, case studies, and expert panel
Speakers
Fran DeGrazio
President & Principal Consultant, Strategic Parenteral Solutions LLC
Fran DeGrazio has 35+ years of experience in the pharmaceutical packaging and delivery industry with extensive expertise in sterile drug product systems, including vial container closure systems and prefillable systems for combination products. Currently Fran is President & Principal Consultant for Strategic Parenteral Solutions LLC. In her current role she advises executives on strategy, growth, technical and regulatory opportunities. She is an active advisor and board member and is Executive Editor for the Drug Delivery Leader community.
Prior to this she held numerous strategic & technical roles at West Pharmaceutical Services, including VP of R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories, Marketing and Scientific Affairs. Her final role prior to retiring was Chief Scientific Officer. Two of her major achievements include establishing West’s contract analytical laboratory in the late 1990s and guiding it to profitability and sustained growth. Prior to her retirement, Fran further revitalized the laboratories by refocusing their objectives and implementing advanced expertise in combination products performance testing. She was also responsible for the concept, strategy, and execution of the Novapure/Novachoice brand of industry leading elastomeric components for West.
Fran has extensive experience in the pharma and biopharma sectors, where she educates and raises industry awareness. She has delivered presentations and authored technical articles and book chapters, including a recent contribution to The Combination Products Handbook-A Practical Guide for Combination Products and other Combined Use Systems (CRC Press, May 2023). Fran is also contributing to the ongoing second edition of this publication.
She is an expert advisor for USP Drug Device Combination Product joint subcommittee, ISPE Combination Products COP, and the AFDO/RAPS Combination Products Summit Steering committee. She is the recipient of the PDA Packaging Science Award for 2021, Philadelphia Business Journal 2018 Healthcare Innovators of the Greater Philadelphia Region Award and the Healthcare Businesswoman’s Association Luminary Award for West in 2017.
Mindy McCann, FRAPS
VP US Operations and Principal Consultant, Qserve Group
Mindy McCann is vice president of US Operations and a Principal Consultant with Qserve Group USA, specializing in global regulatory affairs, quality systems and clinical for medical devices. She has over 30 years of multi-faceted hands-on medical device regulatory experience, having worked for a start-up, a large global company, and two notified bodies, prior to consulting. McCann’s has experience in executive-level regulatory affairs and business management positions, consulting, regulatory specialist, product reviewer, auditor, and development and process engineering. She is a RAPs Fellow and currently serving on the RAPs Board of Directors.
Kevin Lentz
Sr. Director Regulatory Affairs, West Pharmaceutical Services
Kevin Lentz is the Senior Director of Regulatory Affairs at West, leading global regulatory activities for medical devices and delivery systems. In his role, Mr. Lentz provides strategic direction and guidance for the development and commercialization of West's medical devices and their customers' combination products. With over 30 years of experience in medical device quality and regulatory affairs since 1993, he has developed an in-depth understanding of the regulatory challenges associated with developing and commercializing medical devices and combination products. These experiences have enabled him to work effectively across multiple geographies with teams and customers to achieve business objectives and bring new medicinal products to market.
Since joining West in 2009, Mr. Lentz has been actively working with On Body Delivery Systems (OBDS) in collaboration with major pharmaceutical companies globally. He brought with him 15 years of experience in small to large medical device organizations, holding positions of increasing responsibility in quality assurance and regulatory affairs, supporting the development, registration, and post-approval activities for implantable and disposable medical devices. Mr. Lentz holds a Bachelor of Science degree in Chemistry from York College of Pennsylvania.
Anya Harry
Vice President and Chief Medical Officer, West Pharmaceutical Services
Dr. Anya Harry currently serves as the Vice President and Chief Medical Officer at West Pharmaceutical Services. With more than 25 years of experience spanning roles as a physician, a drug and device regulator at FDA, and a leader in the pharmaceutical and packaging industry, Dr. Harry spearheads the Applied Research and Clinical Affairs team at West, focusing on innovative solutions for the containment and delivery of injectable medicines.
Before joining West, Dr. Harry was Global Head of Global Demographics and Diversity at GlaxoSmithKline. In this role, she built a comprehensive framework facilitating diverse and clinically relevant representation in clinical trials across the company's portfolio. Her tenure at GSK also saw her excel as a Clinical Development Director within the Respiratory Therapeutic Area, where she managed both early and late phase assets from candidate selection through to approval and successful commercial launch.
Her time at FDA saw her in multiple leadership roles including Respiratory Devices Branch Chief and Acting Clinical Deputy Director at CDRH. Dr. Harry's clinical experience extends to being an Attending Intensivist at Inova Fairfax Hospital's ICU, a Level 1 trauma center in Falls Church, VA.
Dr. Harry earned her M.D. and Ph.D. from the Mount Sinai School of Medicine, completed her Internal Medicine Residency at Yale University. Her specialized training in Pulmonary and Critical Care Medicine was through a combined fellowship at the National Institutes of Health and the University of Pennsylvania
Location
West Pharmaceutical Services
530 Herman O West Drive
Exton, PA 19320
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
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
support@raps.org.