6TH & 7TH SEMI-ANNUAL MEDICAL DEVICE PACKAGING APRIL 27-28, 2017 / ALEXANDRIA, VA JUNE 26-27, 2017 / SAN JOSE, CA
Elevating Package Design of Medical Devices by Incorporating End User Feedback, Robust Testing Methods and Use of Innovative Materials to Reduce Cost, Ensure Safety and Surpass FDA and International Regulatory Expectations Program Overview: As medical devices have become increasingly complex, the intricacies of creating advanced packaging has progressed to ensure the continued safety and effectiveness of medical products. As such, medical device companies must consider a plethora of factors when designing and developing packaging, including human factors, sterility assurance, material characteristics and overall cost. Gathering as an industry provides packaging engineers an opportunity to hear innovative solutions for tackling the ongoing challenge of balancing cost and quality in packaging design and testing.
The 6th and 7th Semi-Annual Medical Device Packaging Conferences will offer packaging engineers a comprehensive and interactive program through a series of case studies, panels and group discussions facilitated by industry, regulatory and end-user perspectives. Topics of greatest concern for medical device packaging teams will be addressed, including FDA’s expectations for documentation and audit preparation, hospital personnel insights on medical device storage, interpretations of ISO 11607 and effective distribution testing methods. Additionally, based on previous attendee feedback, the 2017 programs will feature a Materials Round-Up where participants will have the opportunity to learn about the latest technologies and materials available to advance medical device packaging. These sessions along with a workshop of nurses simulating the handling of medical devices in a hospital environment will provide attendees with a unique and invaluable experience.
Topics to be Addressed Include: • Human factors in package design: blending the science of engineering with human predispositions • Tackling increasingly complex FDA audits by understanding documentation expectations • Clarifying ISO 11607 updates on “new equipment” and the need for revalidation • Ethylene Oxide sterilization: understanding proper materials for sterilization • Effectively using less packaging while maintaining sterility of device • Distribution testing: lessons on appropriate intensity of distribution testing • Innovative sterilization methods: methods that accelerate speed to market • Overview of new technology related to packaging materials • Last thousand feet: customer perspective of the handling of device packaging in hospital • Summary of updates to ASTM D4169 and what is on the horizon • Examining total cost of packaging process to identify strategies to drive down costs • Navigating methods to encourage sustainability with packaging manufactures and hospitals • Sample size validation: ensuring validation has a statistical rationale • Consumer packaging trends and forecasting for the future of medical device • Dissecting International regulations on the horizon for a variety or regions • Innovations in the packaging process: new ways of assembling and sealing devices • Sustainability and packaging: Understanding how to improve environmental impact
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
6TH & 7TH SEMI-ANNUAL MEDICAL DEVICE PACKAGING APRIL 27-28, 2017 / ALEXANDRIA, VA JUNE 26-27, 2017 / SAN JOSE, CA
PREVIOUS ATTENDEES INCLUDE: Packaging Engineer, 3M Assistant Packaging Engineer, ABBOT VASCULAR ATTENDEE PROFILE: Pancaking Engineer, ACELL Executives that will find this program of greatest relevance are those Director, Engineering, ACUMED currently working to maintain the corporate compliance & ethical Sr. Engineer to Project Engineer, ALLERGAN considerations of medical device and diagnostic corporations. Job titles of Senior Packaging Engineer, AMERICAN MEDICAL SYSTEMS those executives that will find this program to be most applicable to their job Senior Quality Engineer, APOLLO ENDOSURGERY functions include: Manager, Packaging Engineer, ARTHREX • Packaging Manager, Packaging Engineering, ARTHROCARE CORP • Global Packaging Chairperson, ASTM COMMITTEE • Packaging Engineer Director EHS and Sustainability, BAXTER • Strategic Packaging Packaging Engineer, BAUSCH & LOMB • Packaging Development Senior Manager, BECKMAN COULTER • Packaging Services Package Engineering Manager, BECTON DICKINSON Manager, Packaging Engineering, BOSTON SCIENTIFIC Asst. Professor, CALIFORNIA POLYTECHNIC UNIVERSITY Director, Packaging Engineering, CARDINAL HEALTH Manager of Packaging Engineering, CONMED-LINVATEC Sr. Packaging Engineer, CONVATEC Senior Packaging Engineer, COOPERVISION SPONSORSHIP OPPORTUNITIES: Packaging Engineering Manager, COVIDIEN Sr. Packaging Engineer, C.R. BARD At this time, there are a variety of sponsorship and exhibition opportunities Sr. Sterile Packaging Engineer, DEPUY SYNTHES available for companies wishing to increase their visibility and participation Senior Packaging Manager, DSM BIOMEDICAL in the program, ranging from keynote speaking opportunities through to Director of Packaging & Standards, DUPONT exhibitor and documentation sponsors. Organizations most suitable for this Packaging Engineer, ECOLAB type of exposure provide services and solutions including: Packaging Engineer, EDWARDS LIFESCIENCES • Regulatory Consultants Manufacturing Engineer Manager, ENDO THERAPEUTICS • Packaging Materials Sr. Manager, Document Control and Labeling, ENDOLOGIX • Package Design Firms Manager, Packaging and Labeling, ETHICON • Packaging Technology Packaging Development Engineer, EXACTECH • Sustainability Experts Director of Filling & Finishing, FUJIREBIO DIAGNOSTICS • Sterilization Services Biomedical Engineer, FDA
OR Product Coordinator, GEORGE WASHINGTON HOSPITAL Global Packaging Manger, HALYARD HEALTH Packaging Engineering Manager, HEARTWARE, INC. ABOUT THE ORGANIZERS: Packaging Manager, HOLLISTER Q1 Productions designs and develops webinars, training courses, Associate Professor, HUMAN MEDICINE conference programs and forums aimed at specifically targeted audiences Manager, Packaging, INTEGRA LIFESCIENCES in order to provide strategic and timely information. Through a rigid Sr. Packaging Engineer, INTUITIVE SURGICAL production process focused on end-user research and design, our team is Director, Packaging Engineer, JOHNSON & JOHNSON able to understand the immediate business concerns of today’s leading Project Engineer, K2M executives. Whether focusing on new or pending legislative issues, Packaging Engineer 1, KIMBERLY CLARK HEALTHCARE enhanced business processes or technologies that will drive efficiency and Senior Packaging Engineer, LIFECELL CORP customer service, our programs provide solutions to the urgent needs of our Packaging Engineer Manager, MARQUET attendees. Packaging Engineer Manager, MEDTRONIC VP of Sterilization Operations, NOVOSCI CHICAGO Senior Packaging Engineer, OLYMPUS MEDICAL 500 N. Dearborn, Suite 500 Contract Sterilization Manager, REVOX STERILIZATION Chicago, IL 60654 AND MANY MORE! Phone: 312.822.8100
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com