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									                      2010 Pharmaceutical Cold Chain Management Conference
           From Cold Chain to Good Distribution Practices – Integrated Supply Chain Management

                                              April 12-13, 2010
                                        Hyatt Regency, Bethesda, MD

Sunday, April 11, 2010

3:00 p.m. - 6:00 p.m.                                                                            Ballroom Foyer
Registration Open

Monday, April 12, 2010

7:00 a.m. - 8:00 a.m.                                                                            Ballroom Foyer
Continental Breakfast - Sponsored by Minnesota Thermal Science

7:00 a.m. - 5:15 p.m.                                                                            Ballroom Foyer
Registration Open

8:00 a.m. - 8:05 a.m.                                                              Haverford/Baccarat Ballroom
Welcome and Opening Remarks
Robert Dana, Senior Vice President of Regulatory Affairs and TRI, PDA

8:05 a.m. - 10:00 a.m.                                                             Haverford/Baccarat Ballroom
Opening Plenary Session: Pharmaceutical Cold Chain Interest Group Updates/Global Regulatory Environment
Moderator: Bob Seevers, PhD, Principle Regulatory Scientist, Regulatory Affairs, CMC, Eli Lilly & Co

In recent years, regulatory expectations for the distribution of temperature sensitive pharmaceuticals have become
clearer: Good Distribution Practice (GDP) is an extension of Good Manufacturing Practice (GMP). This session will
provide updates on the efforts of the Pharmaceutical Cold Chain Interest Group (PCCIG) to offer leadership on the
"What" and the "How" of GDP, practical advice on monitor placement, and offer fresh insight into the FDA's view
of this essential effort.

8:05 a.m. - 8:30 a.m.
Overview of Pharmaceutical Cold Chain Interest Group (PCCIG)
Rafik Bishara, PhD, Leader, Pharmaceutical Cold Chain Interest Group and
Chair, 2010 PDA Pharmaceutical Cold Chain Management Conference Program Planning Committee

8:30 a.m. - 9:00 a.m.
Temperature Monitor Placement in Active and Passive Packouts
Geoffrey Glauser, Director, Global Packaging Technology, Wyeth Pharmaceuticals

9:00 a.m. - 9:30 a.m.
Cold Chain Regulatory Environment
Rosa Motta, Compliance Safety Officer, CDER/FDA

9:30 a.m. - 10:00 a.m.
Question and Answer
9:45 a.m. - 6:30 p.m.                                                       Waterford/Lalique Suite/Ballroom Foyer
Exhibit Area Open

10:00 a.m. - 10:45 a.m.
    • Refreshment Break in Exhibit Area                                     Waterford/Lalique Suite Ballroom Foyer
    • Poster Presentations                                                                          Ballroom Foyer

                        Pharmaceutical Cold Chain Management Poster Presentation Listing

A Novel Cryopreservation System for Dental Pulp Derived Mesenchymal Stem Cells
Vinod Vilivalam, PhD, Director, Strategic Market and Technical Development, West Pharmaceutical Services, Inc.

Convection vs. Conduction-Designing the Optimal Temperature Controlled Packages
Preston Williams, Vice President of Reasearch and Development, Entropy Solutions, Inc.

Why Data Management is Helpful in Managing Temperature Sensitive Supply Chains
John Bratz, Professional Services Life Science Manager, Sensitech, Inc

10:45 a.m. - 12:15 p.m.                                                        Haverford/Baccarat Ballroom
Plenary Session 2: Security for Temperature Controlled Pharmaceutical Products
Moderator: James Dowden, Director, Distribution and Warehouse Services, Roche

Security is a critical component in today’s global transportation environment. This focus on transportation security is
driven by both global regulatory requirements as well as by supply chain partners taking actions to ensure a
proper chain of custody and maintenance of product/shipment integrity for their products. Temperature controlled
pharmaceuticals represent a unique challenge within this context and this session will address the regulations and
the practices to ensure both security and product integrity objectives are achieved.

10:45 a.m. -11:05 a.m.
Certified Cargo Screening Program on the Shipper
Sean E. O’Neill, Transportation Manager, Supply Chain Region North America, Genetech, Inc

11:05 a.m. - 11:25 a.m.
Status of the Certified Cargo Screening Program
Marc Rossi, Branch Chief, Certified Cargo Screening Program, TSA

11:25 a.m. - 11:45
Secure Supply Chain Pilot Review
Thaddeus Poplawski, Consumer Safety Officer, ORA/FDA

11:45 a.m. -12:15 p.m.
Question and Answer

12:15 p.m. - 1:15 p.m.                                                                              Concours Terrace
Lunch




                                                           2
1:15 p.m. - 2:45 p.m.                                                               Haverford/Baccarat Ballroom
Plenary Session 3: Cold Chain at the Wholesaler and Retailer
Moderator: Claude Jolicoeur, Director, Regulatory Affairs, McKesson Canada

This session will provide some of the newly developed solutions by wholesalers for the temperature controlled
products

1:15 p.m. - 1:45 p.m.
Maintaining Supply Chain Integrity – A Wholesaler’s Solution for Qualified Cold Chain Shipments
Chris J. Anderson, Director, Quality and Regulatory Affairs Management, Cardinal Health

1:45 p.m. - 2:15 p.m.
HDMA-Guidelines for Managing Cold Chain and Temperature-Sensitive Products
John Howells, Senior Director, Industry Relations, Healthcare Distribution Management Association (HDMA)

2:15 p.m. - 2:45 p.m.
Question and Answer

2:45 p.m. - 3:30 p.m.
    • Refreshment Break in Exhibit Area                                  Waterford/Lalique Suite/Ballroom Foyer
    • Poster Presentations                                                                       Ballroom Foyer

3:30 p.m. - 5:00 p.m.                                                         Haverford/Baccarat Ballroom
Plenary Session 4: Radio Frequency (RF) Energy vs. Biopharmaceuticals and Case Studies of Practical Uses of
RF in the Pharma Supply Chain
Moderator: Dave Ulrich, QA Director, Distribution, Abbott Laboratories

This session will feature a discussion of Energy Input vs. Protein/biopharma issues (FDA's CPG section 400.210) and
2 practical RF case-studies

3:30 p.m. - 4:00 p.m.
Using RF Through the Cold Chain Supply Chain to Improve Compliance
Arminda Montero, Distribution QA Program Manager, Abbott Laboratories

4:00 p.m. - 4:30 p.m.
Bulk Pharmaceutical Importation with RFID Tags
Scott Rasmussen, Software QA Manager, Abbott Laboratories

4:30 p.m. - 5:00 p.m.
Question and Answer

5:00 p.m. - 6:15 p.m.                                                    Waterford/Lalique Suite/Ballroom Foyer
Networking Reception in Exhibit Area




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Tuesday, April 13, 2010

7:00 a.m. - 8:00 a.m.                                                                              Ballroom Foyer
Continental Breakfast - Sponsored by Minnesota Thermal Science

7:00 a.m. - 3:30 p.m.                                                                              Ballroom Foyer
Registration Open

8:00 a.m. - 9:30 a.m.                                                               Haverford/Baccarat Ballroom
Plenary Session 5: ISTA Standards for Temperature-Controlled-Products
Moderator: Ed Church, Executive Director, ISTA

The results of ISTA’s Hot and Cold Profile Study of the 2nd Day parcel shipping environment within the United States
and the development of a new Manual for qualifying cold chain packaging will be presented.

8:00 a.m. - 8:20 a.m.
Data Formatting, Analysis and Development of General Hot and Cold Temperature Profiles
William Pelletier, PhD Candidate, University of Florida

8:20 a.m. - 8:40 a.m.
A Case Study: P-002 Pallet Insulated Shipper Design & Qualification Process
Brian Wallin, Packaging Engineer I, Amgen, Inc

8:40 a.m. - 9:00 a.m.
ISTA Thermal Laboratory Certification Program
Rod Derifield, Founder and Chief Executive Officer, EnviroCooler

9:00 a.m. - 9:30 a.m.
Question and Answer

9:15 a.m. - 3:30 p.m.                                                    Waterford/Lalique Suite/Ballroom Foyer
Exhibit Area Open

9:30 a.m. - 10:15 a.m.
    • Refreshment Break in Exhibit Area                                  Waterford/Lalique Suite/Ballroom Foyer
    • Poster Presentations                                                                       Ballroom Foyer

10:15 a.m. - 11:45 a.m.                                                           Haverford/Baccarat Ballroom
Plenary Session 6: Good Cold Chain Distribution Practices
Moderator: Jeff Seeley, Associate Director, Distribution Packaging, Merck and Company

Presenters in this session will outline in-transit thermal mapping conducted to capture the worst-case scenario
during summer and winter months; and will look at the factors at and around an airport that have led to successful
temperature controlled air cargo.

10:15 a.m. - 10:45 a.m.
In-transit Thermal Mapping Project
Nish Chudasama, Associate Manager, US Transportation, Bristol Myers Squibb

10:45 a.m. - 11:15 a.m.
Temperature Controlled Air Cargo at Non-Traditional Gateway Airports: No Excursions Allowed
Christofer Matney, Air Service Director, Indianapolis Airport Authority




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11:15 a.m. - 11:45 a.m.
Question and Answer

11:45 a.m. - 1:00 p.m.
Lunch on your own (A listing of local restaurants is available at the PDA registration desk)

1:00 p.m. - 2:45 p.m.                                                                  Haverford/Baccarat Ballroom
Plenary Session 7: Risk Mitigation
Moderator: Maryann Gribbin, Director, Quality Assurance, Johnson and Johnson

This session will provide technologies, quality systems and risk based tool for mitigating the temperature controlled
challenges.

1:00 p.m. - 1:30 p.m.
Using New Technologies to Solve the Cold Chain Challenge
Vincent Porzio, Manager Engineering & Technical Services, Merck, Inc

1:30 p.m. - 2:00 p.m.
Incorporating Quality Compliance in the Temperature Controlled Distribution of Blood and Blood Components
Boriana Cavicchia, Manager, Systems Quality, American Red Cross

2:00 p.m. - 2:30 p.m.
A Risk-based Approach to Temperature Control and Monitoring Decisions for Ambient Products
Maryann Gribbin, Director, Quality Assurance, Johnson and Johnson

2:30 p.m. - 2:45 p.m.
Question and Answer

2:45 p.m. - 3:30 p.m.
    • Refreshment Break in Exhibit Area                                    Waterford/Lalique Suite/Ballroom Foyer
    • Poster Presentations                                                                         Ballroom Foyer

3:30 p.m. - 5:00 p.m.                                                          Haverford/Baccarat Ballroom
Plenary Session 8: Cold Chain Partners - Innovative Solutions
Moderator: Karl Kussow, Manager, Quality and Validation, FedEx Custom Critical

As Good Distribution Practices become increasingly important for temperature sensitive pharmaceuticals, biologics
and devices in the global economy, we can all benefit from staying up to date with the changing technology and
services that can improve our ability to store and transport these materials in a safe and efficient way. This session
will provide examples and a discussion of some new technologies and processes and how they have been
implemented in the Cold Chain.

3:30 p.m. - 4:00 p.m.
Implementing Green PCM Packaging Solutions
Eric Lindquist, President, Entropy Thermal Management Technologies

4:00 p.m. - 4:30 p.m.
GMP Product Transportation: Producing Locally, Shipping Globally, Being Environmentally Responsible
Jennifer Veerasamie, Black Belt, CIBA Vision Sterile Manufacturing
Gerry Marasigan, Director, Validation and Compliance, SNC Lavalin Pharma

4:30 p.m. - 5:00 p.m.
Question and Answer




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5:00 p.m.
Closing Remarks and Adjournment
Rafik Bishara, PhD, Leader, Pharmaceutical Cold Chain Interest Group and
Chair, 2010 PDA Pharmaceutical Cold Chain Management Conference Program Planning Committee

Notes:




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