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2017 Presentations

Make your Data Work Hard for You Part 2

Make your Data Work Hard for You Part 2

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

Make your Data Work Hard for You Part 1

Make your Data Work Hard for You Part 1

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.

USP <1079> and the Evolution of GDP

USP <1079> and the Evolution of GDP

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.

Building an Organizational Standard

Building an Organizational Standard

  • 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

Managing Contingencies during End-to-End Distribution

Managing Contingencies during End-to-End Distribution

  • 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

Import/Export Complexities in the Indian & APAC Regions

Import/Export Complexities in the Indian & APAC Regions

  • 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

Integrated Risk Management Framework

Integrated Risk Management Framework

  • 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

DSCSA’s Impact on Global Supply Chain

DSCSA’s Impact on Global Supply Chain

  • 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

Optimization with Pallet Solutions

Optimization with Pallet Solutions

  • 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.

Presentation by:

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

Health Canada Guide-0069 - Regulatory Provisions

Health Canada Guide-0069 - Regulatory Provisions

  • 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

Addressing Unmet Medical Needs through Industry Collaboration

Addressing Unmet Medical Needs through Industry Collaboration

  • 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