• IATA Chapter 17 Revised Regulations for Temperature Sensitive Healthcare Products
• Underlining European Regulatory Expectations for Temperature Sensitive products
• USP Chapter 1079: Industry Feed Back and Next Steps
• Quality Management for Temperature Monitoring – A Regulatory Perspective
• Temperature Monitoring During Warehousing and Transportation
• Implementing Cold Chain Controls from Manufacturing to Distribution for Cold Chain Pharmaceutical Products
• "Last Mile" Related Temperature Monitoring Challenges
• International Focus: Import/Export Shipping Challenges and Best Practices
• Protecting Pharmaceutical Shipments in both In-Transit & Warehouse Storage
• Risk-Based Approaches for Effective Cold Chain Management
• System to Maintain Cold Chain Integrity
• Case Study: Thermal Property Analysis of Product Payload for Shipper Qualifications
• Temperature Mapping Trade Lanes, Approach and Results to the Study: Benefits and use of the data
• Successful Selection and Implementation of Temperature Controlled Containers
• Potential Impact on Engineered Packaging and Temperature-Controlled ULDs Transported via Composite-Based Aircraft.
• Airline cargo capacity challenges in the future
• Reusing Passive Shippers – Considering the Thermal, Environmental and Economic Impact to your Cold Chain Management Process

MEDIA SPONSOR

Dr. Umit Kartoglu, MD, DPH Scientist World Health Organization

Dr Kartoğlu is a scientist at the World Health Organization, Department of Immunization, Vaccines and Biologicals, Quality, Safety and Standards team. He is responsible for prequalification of all devices and equipment used in immunization services including vaccine vial monitors. Dr Kartoğlu also coordinates the work of Global Training Network for Vaccine Quality. Prior to his WHO work, Dr Kartoğlu worked with UNICEF as health officer in Central Asian Republics and Kazakhstan Area Office and as health coordinator for Operation Lifeline Sudan based in Kenya. Earlier he was Associate Professor in Public Health at the Institute of Pediatrics of Istanbul University and also held positions as permanent advisor in Public Health to the Ministry of Health in Turkey, and worked in different positions in rural health delivery system for 10 years. He is the founder of the Human Rights Branch of the Turkish Medical Association and WEBCOM (Communication Web for Health). He was elected to serve in the Executive Council of the Turkish Medical Association for a term in 1988. Dr Kartoğlu has 45 professional publications in public health including seven books/manuals targeting primary health care professionals used as teaching materials, and received two international research awards in research design and communication. Dr Kartoğlu has over 20 years of experience in competency based training, and has developed various instructional training course materials as well as creative tools for courses.

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Mr. John Taylor Quality and Standards Manager MHRA

John Taylor is the Quality and Standards Manager for the UK medicines and medical devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

John joined the Agency in 1991 after working in the pharmaceutical industry for 24 years in quality control, quality assurance, research and development and regulatory affairs. He worked firstly as a medicines inspector and then moved upwards and onwards to develop and implement the Agency’s quality management system. In addition to specialising in quality management, John is a recognised authority on good distribution practice of medicinal products. He is a member of the European Compliance Academy Advisory Board and Qualified Person Association.

John is a Chartered Chemist and a Fellow of the Royal Society of Chemistry.

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Dr. Mary Foster USP Packaging and Storage Expert Committee Member US Pharmacopeia (USP)

Mary Foster, PharmD, Vice-President Quality, Catalent Pharma Solution, is responsible for building external relationships with regulatory bodies, pharmacopeia and industry working groups within the pharmaceutical/biotechnology and consumer healthcare sectors. Dr. Foster has been with Catalent for 20 years having served in various quality and regulatory leadership roles. Dr. Foster has been elected Chair of the United States Pharmacopeia (USP) Packaging, Storage and Distribution Expert Committee for the 2010-2015 USP cycle. As the Committee Chair, Dr. Foster’s responsibilities will include the creation of new standard USP General Chapters as well as the revision of current standard general chapters. Over the 2005-2010 USP cycle, Dr. Foster provided USP committee updates to industry in the US, Canada, the EU and South America and presented at the 2008 and 2009 Annual USP meetings. Dr. Foster routinely presents cGMP training courses in the US, Canada and the EU. She is an Advisory Board member of the International Air Transportation Association (IATA) and a member of the Parenteral Drug Association (PDA) Pharmaceutical Cold Chain Interest Group (PCCIG) committee.

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Mr. Bobby Boehm Associate Director, Cold Chain Management Bristol-Myers Squibb

Bobby Boehm is currently with the Logistics and Transportation organization for the Americas at Bristol-Myers Squibb Company.

Bobby is a subject matter expert in Transportation and Cold Chain Management with over 20 years experience.  Prior to BMS Bobby provided consulting services managing the supply chains of several major pharmaceutical companies. 

He is an active member of the PDA and works closely with the Pharmaceutical Cold Chain Interest Group.

Bobby is a graduate of the University of Mississippi.

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Mr. Charles Forsaith Corporate Director, Supply Chain Security Purdue Pharma L.P.

Charles Forsaith joined Purdue Pharma in 2001 and currently serves as its Corporate Director for Supply Chain Security. Forsaith served as a New Hampshire State Police Officer for more than 20 years and worked in supervisory capacities in the Major Crime, Narcotics and Intelligence Units. Forsaith has given lectures on Criminal Justice and Security at such organizations as Notre Dame College, the U.S. Merchant Marine Academy and the FBI. He is a member of the American Society of Industrial Security, the Transported Asset Protection Association, the National Association of Drug Diversion Investigators and the International Association of Chiefs of Police.

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Mr. Kevin O’Donnell Director & Chief Technical Advisor, ThermoSafe Brands Chair, IATA Time & Temperature Task Force

Kevin O’Donnell is Director & Chief Technical Advisor to Industry for Tegrant Corporation, ThermoSafe Brands. He retired in 2005 from Abbott Laboratories, as Principle Packaging Engineer, and was responsible for the design, development, qualification and implementation of all temperature controlled distribution packaging for the Abbott Global Pharmaceutical Division. His 26 year career at Abbott included more than 20 years of temperature assurance packaging experience in the Diagnostics Division, the International Division, and Global Pharmaceutical Operations Logistics and Supply Chain. His latest endeavors are focused on “from the top-down” improvements in cold chain management and distribution. Much of his time is spent as Chair of the International Air transport Association (IATA) Live Animals & Perishables Board Time & Temperature Task Force (the first non-airline member ever to be elected to such a post). The cross-industry task force is currently revising IATA’s Perishable Cargo Regulations Chapter 17 “Air Transport Logistics for Temperature-Sensitive Healthcare Products,” establishing a Quality Management System for airlines and their partners, and developing a standardized handling label specific to time- and temperature-sensitive healthcare products.

In addition, Mr. O’Donnell is a member of the World Health Organization (WHO) Task Force on Regulatory Oversight on Pharmaceutical Cold Chain Management, and a founding member of the Parenteral Drug Association Pharmaceutical Cold Chain Discussion Group (PDA-PCCDG, now the PCCIG), and co-author of the Cold Chain Guidance Document for Medicinal Products:
Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment, PDA Technical Report #39. As an author and educator, Mr. O’Donnell is well respected throughout the Pharmaceutical industry in the US and in Europe as a leading advocate for implementing good cold-chain distribution practices.

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Mr. Mark Mohr Manager, Product Development and Specialty Sales Continental Airlines Cargo

Mark Mohr is Manager Product Development and Specialty Sales for Continental Airlines Cargo. Mark has global sales, marketing and development responsibility for numerous products including ClimateSecure™, Continental’s suite of temperature-controlled shipping solutions. Previously, Mark was director of United Airlines Cargo’s general sales agent (GSA) operation in the US, and before that held various sales and operational positions at DHL Worldwide Express. Mark currently serves on the International Air Transport Association’s “Time and Temperature Task Force”. The task force is charged with enhancing and expanding airline regulations related to proper handling of temperature-controlled Pharmaceutical shipments.

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Mr. Andrew Hecht Director, Global Accounts World Courier

Biography to be posted shortly

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Mr. Eric A Newman Vice President, ProTecht Risk Solutions Falvey Cargo Underwriting

Eric Newman is a Vice President of ProTecht Risk Solutions, a division of Falvey Cargo Underwriting. As practice leader for life science and cold chain supply management, Eric provides consultative services in risk mitigation programs and practices. Eric consults directly with clients as a loss prevention resource in all facets of supply chain management, including development and implementation of packing, shipping and storage procedures that are aligned with industry best practices and best-in-class cold chain distribution processes.

Eric is a member of the PDA’s Pharmaceutical Cold Chain Interest Group (PCCIG), Transport Packaging Committee of the Institute of Packaging Professionals (IoPP), Transported Asset Protection Association (TAPA) and the Pharmaceutical Cargo Security Coalition (PCSC). Eric also serves as an advisory board member of the International Maritime Business Department at the Massachusetts Maritime Academy.

Before joining Falvey Cargo Underwriting, Eric was President of Newman Marine, Inc., a marine risk consulting company that provided independent risk management and cargo claim investigative services to the marine cargo insurance industry.

Eric graduated from the Massachusetts Maritime Academy with a BA in Marine Transportation and upon graduation, sailed as a USCG licensed merchant marine officer aboard ocean going commercial cargo vessels. After completing his sailing career, Eric worked as a marine cargo surveyor for 15 years.

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Mr. Claude Jolicoeur Director, Regulatory Affairs McKesson Canada

Claude is the Director of Regulatory affairs and Corporate GMP officer for McKesson Canada. Claude has 25 years of experience in distributions and logistics. He has been involved in the pharmaceutical industry for 15 year. In his role Claude interacts regularly with the 15 Distribution centres McKesson Canada has throughout Canada in all aspects of the Food and Drug regulation, which includes prescription drugs, controlled substances, precursors, medical devices, cosmetics and natural health products. Part of his work is also related in finding and qualifying cold chain solutions that make good business sense.

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Mr. Jeffrey Simpson Director, Engineering & Technical Services Cold Chain Technologies

Jeff earned a B.S in Mechanical Engineering from UMass Lowell. He is Director of Engineering and Technical Services for Cold Chain. Jeff has 19 years experience in mechanical engineering, engineering management, and program management. He manages a cohesive group of technical professionals who are responsible for applying engineering principles to the design, development, and qualification of thermal packaging solutions.

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Mr. Eric Lindquist President Entropy Thermal Management Technologies

As President of Entropy Solutions Inc., Eric Lindquist oversees the company's overall strategic direction, leads the development of major business partnerships and manages the company's day-to-day business operations. Under Eric's leadership, Entropy Solutions launched GREENBOX, the company's patented thermal management packaging system in December 2007. GREENBOX is currently being used by some of the largest pharmaceutical and biological product manufacturers in the world.

Previously Eric was Vice President and General Manager of a division of Contech Construction Products where he directed the firm's strategic growth efforts and B2B licensing/manufacturing operations. He also worked for Polaris Industries in Minneapolis, serving as General Manager for the snowmobile division, overseeing development, production and marketing. In addition, he served as Director of Sales, Americas Region for Nike Inc. in Beaverton, Ore., where he was responsible for all commercial strategy for the division.

Eric holds a Bachelor of Science from the Kelley School of Business at Indiana University, and completed graduate work at the St. Gallen School of Business in St. Gallen, Switzerland.

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Mr. Rick Lenhard Lead Engineer, Passive Systems AcuTemp Thermal Systems

Rick is a Veteran of the U.S. Air Force and earned a Bachelor of Science in Engineering from the Montana College of Mineral Science and Technology. Also a seasoned veteran of passive shipper development and qualification testing, Rick has 20 years of experience in the design of insulated shipping boxes utilizing thermal and structural research to provide solutions with performance integrity. Rick is instrumental in ensuring that AcuTemp products are optimally designed and produced to meet today’s cold chain management requirements.

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DAY ONE Tuesday, November 2, 2010
08:00 – 09:00	Conference Registration & Continental Breakfast
09:00 - 09:15	Underlining European Regulatory Expectations for Temperature Sensitive products
	A review of regulations and guidance in Europe Good distribution practices Strengthening the medicines supply chain
09:15 - 10:00	Quality Management for Temperature Monitoring – A Regulatory Perspective
	An inspector’s expectations Quality management in documentation and records Regulatory inspection findings
10:00 - 10:45	Last Mile: Improving Temperature Monitoring at the Periphery
	Last mile access and distribution challenges Active and passive approaches in last mile reach out Why temperature monitoring becomes more critical at the last mile Best practices to monitor temperatures at the last mile Reaching the unreached: Beyond the cold chain
10:45 – 11:00	Mid-Morning Networking, Refreshment, & Exhibition viewing
11:00 - 11:45	International Focus: Import/Export Shipping Challenges and Best Practices
	Regulatory - preparation – new markets Site vs. depot Packaging – what considerations? What’s new? Compliance - GxP Customs – cold chain? Courier Selection – capabilities/needs Troubleshooting – overcoming hurdles
11:45 - 12:30	USP Chapter 1079: Industry Feed Back and Next Steps
	Feedback Overview Revision Update Process Timeline Final Outcomes
12:30 - 13:45	Lunch, Networking, Refreshment, & Exhibition viewing
13:45 - 14:30	Airline Cargo Capacity Challenges
	Key drivers of increased cubic volume – vaccines, pharmaceutical, biologics State of the airline / air cargo industry, current and future survival scenarios, fleet, routes and consolidation Regions/airports that are of most concern The domino effect Overcoming the challenges
14:30 - 15:15	Implementing Cold Chain Controls from Manufacturing to Distribution for Cold Chain Pharmaceutical Products
	Challenges in the supply chain from API to patient Qualification of suppliers and service providers A cold chain pedigree?
15:15 - 15:30	Mid-Afternoon Refreshment Break, Networking & Exhibit Viewing
15:30 - 16:15	System to Maintain Cold Chain Integrity
	Long distance solutions Short distances solutions Warehouse temperature monitoring Calibration Fridge qualification
16:15 - 17:00	Potential Impact on Engineered Packaging and Temperature-Controlled ULDs Transported via Composite-Based Aircraft
	Composite-based aircraft are anticipated to have different operating ambient conditions than aircraft constructed of traditional materials. Composite-based aircraft are designed to offer extended flight ranges which translates into longer transit times Optional cargo compartment air conditioning systems
17:00 - 17: 30	Round Table Discussion, Q&A session continue exploring the topics presented in Day 1 Sessions
18:00 - 19:00	Networking Reception
DAY TWO Wednesday, November 3, 2010
08:00 – 09:00	Continental Breakfast
09:00 - 10:00	Protecting Pharmaceutical Shipments in both In-Transit & Warehouse Storage
	Statistics of Cargo Theft in the US Incident Examples of Pharmaceutical Cargo Thefts Technology Used to Combat Cargo Theft Government Programs Supporting Supply Chain Security Pharmaceutical Cargo Security Coalition
10:00 - 10:45	IATA Chapter 17 Revised Regulations for Temperature Sensitive Healthcare Products
	A review of the major revisions to Chapter 17 of the 10 Edition of the Perishable Cargo Regulations (effective July, 1, 2010) Steps for implementing a successful Chapter 17 compliant program What changes to expect for 2011-2012 edition
10:00 - 11:00	Mid-Morning Networking, Refreshment, & Exhibition viewing
11:00 - 11:45	Risk-Based Approaches for Effective Cold Chain Management
	Effective risk management of cold chain issues with the distribution network of a supply chain requires consideration of several challenging elements including regulatory, logistics, financial and operational considerations. Balancing amongst these often contradictory constraints and implementing an optimal logistics solution is an iterative challenge that requires consistent on-going evaluation and adjustment. A viable distribution program often starts with the development of comprehensive operating procedures (SOPs) that encompass all logistics processes. Critical challenges arise in the selection-and-management of transportation vendors and the implementation of control elements to assure all logistics elements are performed as designed. This session will explore the key elements of a PROACTIVE supply chain risk management program including: Transportation vendor vetting, collaboration and review Negotiation to incorporate SOPs directly into a logistics contract Threat/exposure identification of cold chain transit risk elements Effective contingency planning for specialized cold chain processes The session will include several "case studies" and practical examples of the types of risk mitigation steps to avoid losses from spoilage, contamination, and other temperature-driven issues.
11:45 - 12:30	Temperature Mapping Trade Lanes, Approach and Results to the Study: Benefits and Use of the Data
12:30 - 13:45	Lunch, Networking, Refreshment, & Exhibition viewing
13:45 - 14:30	Reusing Passive Shippers – Considering the Thermal, Environmental and Economic Impact to your Cold Chain Management Process
	Anticipated double digit growth for biologic and pharmaceutical temperature sensitive products; increased scrutiny by regulatory agencies on the safe handling of temperature sensitive products to ensure patient safety; heightened awareness of making environmentally responsible choices - these are a few of the important factors to consider when investigating the feasibility of reusing passive shipping containers. In a case study format, this discussion examines the thermal integrity of shippers after multiple uses, re-qualification practices, the impact a reuse program can have in reducing landfill waste, and the economic factors to consider when choosing to reuse your passive shippers.
14:30 - 15:15	Successful Selection and Implementation of Temperature Controlled Containers
	Gain an understanding of the critical factors for consideration when determining the implementation of thermal sensitive packaging. With new materials and process available today, you will learn what systems are best for various types of distribution. Topics discussed will include: Reusable vs. One & Done thermal systems Conduction based systems vs. Convection based systems Important validation criteria Utilizing engineered phase change materials Package reclamation vs. recycle
15:15 - 15:30	Mid-Afternoon Refreshment Break, Networking & Exhibit Viewing
15:30 - 16:15	Temperature Monitoring During Warehousing and Transportation
	Warehouse monitoring systems Route temperature profiling  tool Use of data logger and indicator in shipments How it relates to Health Canada Guideline 0069
16:15 - 17:00	Case Study: Thermal Property Analysis of Product Payload for Shipper Qualifications
	Pharmaceutical manufactures ship a wide variety of thermally sensitive products to various locations around the world. Traditionally, most shipper qualification studies have used various min/max load criteria to define the product loads to be included in the study, and the qualification results are product specific. With the current economic pressures and environmental awareness issues, pharmaceutical manufacturers and wholesalers are looking to develop a standard set of shipping solutions that are qualified to accept a variety of payloads. As such, it is advantageous to define the acceptable product load characteristics in such a way that they can be applied to multiple products, including those under development. CCT proposes to present a case study where various product payloads, in identical shipping systems and subjected to the same ambient profiles are tested and then compared. This case study would compare payloads based on mass, product type (liquid, lyophilized), occupied volume (syringe, vial) and quantity of product. The differences in the test results will be explained using a (high level) review of heat transfer mechanisms and thermodynamic analysis. The case study will provide insight to the effects of convection and conduction both inside the shipper and inside the product load. Attendees will gain valuable insight into how to select proper payloads for qualification, as well as an understanding of the impact of what can happen when these scientific methods are not utilized.
17:00 - 17:15	Q&A session continue exploring the topics presented in Day 2 Sessions
17:15	The Meeting Adjourned

This two day conference, with case studies and workshops, is directed toward Directors, Managers, Supervisors, and Associates in the Pharmaceutical, Biopharmaceutical, Biotechnology, and allied industries with responsibilities in the following areas:

• Transportation
• Distribution
• Logistics
• Packaging
• Warehousing
• Supply Chain
• Stability
• Quality Control
• Quality Assurance
• Validation
• Anti-Counterfeiting
• Security
• Operations
• Materials Management
• Engineering
• Documentation
• Regulatory Affairs
• Customer Service
• Retail and Wholesale 
  

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Event Name: Cold Chain & Logistics Management Conference 2010 - Somerset, New Jersey, USA	Registration fee:
Early Bird: Before July 31, 2010	USD $975
IPA Special: August 1, 2010 to October 26, 2010	USD $1200
Regular Price: October 27, 2010 to November 2, 2010	USD $1395

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Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments

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All cancellations are subject to a USD $150.00/person processing fee. To receive cancellation credits for attendance at an upcoming course, IPA must be notified of the cancellation in writing (by email, mail or fax) up to 3 weeks prior to the program start date. Cancellations submitted less than 3 weeks prior to the event will not be qualified for refund or credit. Substitution of delegate/s with the member/s of the same organization is permitted at any time with no penalty.

IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.

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For more information, please call us at 416-410-7402 or enquiry@ipacanada.com