An overview of Eli Lilly’s Initiatives for Increasingly Effective Lane Data Analysis. Hear how Eli Lilly is using climate data to design containers for the varying seasons through simulations & pilots. Find out how to use weather data to come up with test profiles and gather lane data in a targeted way.
Presentation by Bernard McGarvey, Ph.D. Sr. Engineering Advisor, Eli Lilly and Company
You Work Hard to Get your Data, Now Make your Data Work Hard for You! Hear how BMS is characterizing lanes for shipping through gathering detailed shock & vibration data. Review their goal to eliminate the need to ship actual product PQ. Presentation by Carolyn Williamson, Principal Packaging Engineer, Bristol-Myers Squibb.
Review the increased globalization of the pharmaceutical industry and its impact on the handling, storage, and distribution of products.
- Take a life cycle management approach to quality, ranging from material procurement to manufacturing to delivery of a final product to the patient
- Ensure each activity in the distribution of a product is carried out according to the principle of Good Distribution Practices (GDP)
- Identify common risks in the storage and transportation of finished drug products and recommended mitigation strategies for these risks
Presentation by Chris J Anderson, Director, Quality Systems, Cardinal Health, USP Packaging and Distribution Expert Committee Member USP Sub-Committee Co-Chair, U.S. Pharmacopeia.
- Create a global team between quality, supply chain, logistics, and packaging to streamline transportation challenges yielding cost savings Implement governance and address the nuances in global GDP regulations by setting an internal standard at the most stringent level
- Complete a GAP analysis of your different product lines to determine where issues may occur
- Collaborate with suppliers to provide visibility on the inbound for raw materials and semi finished goods for PO’s throughout the entire life cycle as well as forecast
Presentation by Dan Mirica, Former Head of Global Logistics, Lonza Biologics
- Discuss at-home and in-clinic portable 2-8°C and CRT storage, with continuous real-time temperature monitoring and inventory management using RFID technology
- End to end traceability and excursion management leads for efficient QA oversight and release which can be achieved from point of manufacture, packaging through patient treatment Review logistical route planning and contingency considerations to minimize risk and loss of highly sensitive medications
- Case studies: Demonstrate successful solutions for the most challenging routes, temperature requirements and complex delivery, including direct to patient and import scenarios
- Technology demonstration of the CubixxCT and cloud based portal
Presentation by Dustin Roller VP of Innovation Product Development ASD Healthcare
- Discuss methods for working around customs challenges leading to potential shipment delays
- How to best interpret the regulations and remain compliant from API’s to finished drug products
- How to work closely with your supply chain partners to ensure SOP’s are being met in these regions
- Hear about potentially temp controlled warehousing options within the regions as a method to mitigate delays within transit
Presentation by Javier Gomez-Contreras Supply Chain BGx LATAM- OE Latina-Mid East Africa- India & Asia Pacific Lead GSK
- Proactively minimize risks to patients, operations, and supply chain through early identification, detection and mitigation
- End-to-end risk review and control of products throughout the supply chain
- Drive continual improvement throughout the product and process lifecycle to ensure a reliable supply of quality products to patients Leverage risk management tools to make risk based decisions in temperature controlled distribution
Presentation by Lisa Wyman Head of Quality Compliance & Data Analytics Shire Pharmaceuticals
- Examine the full scope of DSCSA requirements and top international serialization deadlines that are looming How can logistics professionals support serialization teams past the 2017 deadline
- What application does serialization technology have for temperature monitoring? Can they work in tandem?
- Predicting how a post-serialized world will affect the pharma supply chain
Presentation by Matt Sample Sr. Director, Secure Supply Chain AmerisourceBergen Corporation
- Evaluation of existing and potential passive and active pallet shipping solutions Walk through analysis of pallet solutions utilizing criteria such as cost savings, ergonomics, and additional supply initiatives
- Review the expedited customization process of a standard product offering to meet ergonomic and performance requirements
- Overview of the implementation strategy and the opportunities for reuse.
Bryan Cardis, Distribution Platform Steward – Global Packaging, Eli Lilly & Company
Christopher Lyons, PE Consultant, Package Engineering, North American Logistics Operations Eli Lilly & Company
Stephen Kolb, Business Development Manager, Cold Chain Technologies
- Review guidelines for products in transit: stability data requirements and temperature mapping
- Discuss the regulatory scope of temperature monitoring for CRT Hear recommended approaches for risk evaluation and mitigation and analyze examples of compliance and non-compliance
- Take a look at what Roche implement locally to distribute to our Canadian customers to fulfill the authority requirements
Presentation by Tonino Antonetti Executive Director, Regulatory Affairs, Quality Management, Safety & Health and Environment Roche Diagnostics Canada
- Review the international landscape of rare disease treatment & new medicines entering the supply chain to treat them How have regulations in both the US & abroad impacted the industry’s ability to reach patients
- Discuss how new technological innovations and supply chain collaboration can make reaching challenging markets more feasible
- Where is the industry headed next? How is the temperature controlled supply chain an integral part of the future?
Presentation by Wesley Schmidt, Vice President of Quality Systems, AbbVie
Presentation by Beth Ruland, Associate Director, Global, Packaging Technology, Bristol Myers-Squibb. Key topic areas include:
- Explore how and why Bristol-Myers Squibb switched from foam to polypropylene insulation for a 2-8 vial product
- Assess the quality and environmental benefits of switching from foam insulation
- Quantify the significant cost savings derived from gaining increased pack-out space, which in one pilot exceeded $300K
- Explore possible next steps in reusing or recycling insulation materials to increase cost savings and sustainability even further
- What is the concept of product quality and what is the philosophy surrounding quality management in supply chain environment
- Correlation between little q and bigger Q in relation to the product quality and supply chain management and how can they impact each other
- How Q.A and Supply chain can cooperate in an Effective Manner to Ensure Seamless Integration of their efforts in order to achieve the Optimal Quality - Supply Chain Solution to the Customers
- Real examples of successful collaboration approaches between Quality and supply chain department
Ahmed ElSheemy, Head of Quality Assurance Middle East & Turkey, Merck Serono Middle East (a subsidiary of Merck KGaA Germany)