Special Thanks To Our 2014 Speakers. If You’re Interested In Speaking Opportunities For The 2015 Conference Please Contact: firstname.lastname@example.org
Presentations From The 2014 Conference:
7:30 REGISTRATION AND MORNING COFFEE
8:20 CHAIRPERSON’S OPENING REMARKS
Joyce Hansen, Vice President, Sterile Process Technology JOHNSON & JOHNSON
8:30 BRINGING INNOVATION BACK INTO THE PACKAGING DESIGN PROCESS
Package design is one of the most crucial elements for packaging executives in the device industry, requiring years of experience and a thorough understanding of the package development process. Along with being cost–effective, design components must be tailored to the HCP for optimum ease of use, safety and product protection. Products requiring specialized packaging attention encourage executives to think outside of the box, implementing new innovations that can reduce superfluous testing, decrease the occurrence of over-packaging, and lower overall operational and material costs. This session will explore new avenues of packaging design that are safe, reusable and guarantee anti-theft while satisfying design lead times with streamlined and effective approaches.
Introduce innovative design elements
Enhancing anti-counterfeiting efforts with packaging design
Designing with the HCP in mind: increasing usability
Amanda Kiefer, Senior Packaging Engineer, Global Packaging,SMITH & NEPHEW
9:15 THE IMPORTANCE OF PACKAGING OPERATIONS IN PACKAGE DEVELOPMENT: A COLLABORATIVE BUSINESS MODEL IN MEDICAL DEVICE PACKAGING
A look at the challenging and comprehensive task of medical device packaging process development and manufacturing integration
Overview of the broad range of tasks involved in the establishment of medical device packaging processes from construction and environmental controls; to equipment acquisition and validation; to process development, implementation and optimization; to regulatory reporting.
A review of the collaborative engineering responsibilities of package design and packaging operations as well as the differentiated, relative regulations and standards. This also includes a look at the effective collaboration with other such key bodies as Sterility Assurance, Product Development, Manufacturing, Facilities, Quality Assurance, and Regulatory in a successful product development process.
John Derek Thompson, Sr. Sterile Packaging Engineer,DEPUY SYNTHES
10:00 COFFEE & NETWORKING BREAK
10:30 OVERVIEW OF UNIQUE DEVICE IDENTIFICATION & INDUSTRY’S PREPARATION FOR COMPLIANCE
A thorough overview of the UDI rule will give clarity to medical device companies regarding appropriate label methodology, best practices for successful implementation, and the benefits for establishing a single unambiguous identification system. Packaging executives are especially interested in understanding this ruling to ensure compliance, as difficulties arise in appropriately placing a label on smaller packaging or devices. Additionally, packaging teams can take the lead in implementing this initiative, as UDI is required on all packaging levels.
FDA UPDATE: TRANSFORMING THE GLOBAL MEDICAL DEVICE LANDSCAPE WITH UDI
Review of legislation and UDI requirements
Emphasizing benefits of a unified labeling system
Timeline for implementation and examples of compliant application
Jay Crowley, Vice President, UDI Practice, USDM
(FORMER SENIOR ADVISOR FOR PATIENT SAFETY, FDA)
11:15 CASE STUDY: SUCCESSFUL IMPLEMENTATION OF UDI REQUIREMENTS FOR PACKAGING
Identification, Evaluation & Selection of the following for a successful UDI Project:
Planning & Executional Strategies
Development of a top-line strategy to achieve executive funding and support for a UDI labeling project
Commonly missed key components of a UDI project
Review UDI project case study
Dawn Fowler, Senior Manager, Labeling & Documentation,ENDOLOGIX
12:00 LUNCHEON FOR ALL ATTENDEES, SPEAKERS AND SPONSORS
1:30 VOICE OF THE END-USER: UNDERSTANDING THE HEALTHCARE PROFESSIONAL’S PERSPECTIVE ON DEVICE PACKAGING Through gaining a better understanding of a nurse’s perspective, packaging executives can implement strategies for safe usage, improvement of design elements and increase of efficiency based on the perspective of those who regularly interact with devices. This panel will center on current package development, critical design characteristics, and attaining a deeper appreciation for usability. Attendees will identify how packaging emerging from the industry affects medical professionals who frequently encounter them, and will engage in an interactive Q&A segment providing valuable insight from an end user’s standpoint.
Understanding how device packaging effects clinicians and nurses
Evaluating design elements from a consumer’s perspective
Exploring areas of opportunity to improve package efficiency
Dawn Hamblett, OR Clinical Product Coordinator GEORGE WASHINGTON UNIVERSITY HOSPITAL
Marissa Gurango, Clinical Product Coordinator
GEORGE WASHINGTON UNIVERSITY HOSPITAL SURGERY CENTER
Jan Gates, Co-President- Southern California Chapter
INSTITUTE OF PACKAGING PROFESSIONALS
2:15 SELECTING A SAMPLE SIZE FOR VALIDATION TESTING OF STERILE BARRIER SYSTEMS & PROTECTIVE PACKAGING
Formulating the appropriate sample size and critical attributes for testing is vital for device packaging executives to successfully validate sterile barrier systems and the protective packaging. Developing testing plans are especially challenging due to ambiguous FDA guidance documents, leaving engineers confused on how to outline sampling plans based on statistically valid rationales. Evaluating how other companies determine the appropriate level of confidence and reliability necessary to validate a system, establish clear rationales based on risk assessment and identify methods for adequate sampling size can support a packaging team’s ability to develop a sound validation testing strategy.
Assess risk tolerance when determining sampling size
Defining statistical rationale for sampling size selection
Regulatory guidelines for sterile barrier systems and protective packaging
Grant Short, Principal Quality Engineer & Lead Statistician,MEDTRONIC
3:00 COFFEE & NETWORKING BREAK
3:30 STERILIZATION SCIENCE: PUSHING THE PACKAGING LIMITS
Innovative techniques such as gas plasma sterilization can expose weaknesses in packaging and help sterilization engineers to design more reliable packaging that maintains its shape, seal strength and integrity throughout the sterilization process. The medical device industry can improve the overall quality of packaging through testing models that reveal how fast gas and ETO seeps into packaging, the retention rate for such elements, and strategies to reduce these occurrences. Raising the gold standard in sterilization sciences requires medical device packaging executives to work hand in hand with sterilization engineers to reveal true areas of opportunity for package development.
Dissipation kinetics of gas seeping into/out of a load
Evaluating limitations of new sterility techniques
Highlight internal collaboration to maximize packaging integrity
Joyce Hansen, Vice President, Sterile Process Technology,JOHNSON & JOHNSON
4:15 PANEL DISCUSSION: SELECTING INNOVATIVE STERILIZATION METHODS FOR VARIOUS PACKAGING MATERIALS
Choosing and implementing a sterilization method proves to be a vital component in maintaining the safety and effectiveness of a medical device, and if a packaging team incorrectly selects a sterilization technique, damages to the packaging or degrading of the medical device can occur. Traditional sterilization methods utilized by packaging executives include ethylene oxide and gamma irradiation, but device manufacturers are always seeking innovative approaches to eradicate any microorganisms and reduce contamination. Assessing new techniques such as vaporized hydrogen peroxide and non-traditional strong pulse light sterilization can reveal areas of opportunity for raising industry standards through material-sensitive sterilization.
Discussing potential hazards of current sterilization strategies
Evaluating effectiveness of new sterilization methods
Determining best practices for sterilizing sensitive packaging materials
Joyce Hansen, Vice President, Sterile Process Technology,JOHNSON & JOHNSON
Michael Johnson, Group Manager, Package Development,SMITH & NEPHEW
Katie Tran, Laboratory Manager, Life Sciences, WESTPAK