Day 2: Main Conference – Tuesday, September 21, 2010

7.00 Registration And Coffee

8.00 Pharma IQ Welcome Remarks

8.15 Opening Remarks From Chairperson

Rafik H. Bishara
PhD,Technical Advisor and Chair PCCIG USA Branch
PDA

8.20 Opening Keynote: Cold Chain - A Business Critical Function

Mary Kuhn
Executive Vice President, Operations
Talecris Biotherapeutics, Inc.

International Regulations & Industry Standards

9.00 Observations And Guidance For Conducting Regulatory Compliant Cold Chain Operations

  • Feedback from recent audits of pharmaceutical manufacturers and noting trends
  • Risk mitigation initiatives from a regulatory perspective
  • Beyond temperature monitoring: Future regulatory concerns on humidity and other parameters
  • Stability data for transportation: Regulatory expectations and shipment outside labeled storage conditions
  • Commenting on the new PDA Stability "In Use' Conditions guidelines

Ian Holloway
Manager, Defective Medicines Report Centre
MHRA

9.40 The Final Updated USP <1079>: Validating And Documenting Each Step Of Your Cold Chain

  • Quality Management System (QMS)
  • Storage Management System (SMS)
  • Transportation Management System (TMS)
  • Environmental Management System (EMS)
  • Industry feedback

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

10.20 Complying With IATA Chapter 17 Revised Regulations For Temperature Sensitive Healthcare Products

  • What’s changed? 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 to expect for 2011-2012 edition.

Kevin O'Donnell
Director & Chief Technical Officer, Tegrant Corporation
Thermosafe Brands

10.40 Morning Networking Break

11.25 Introducing The New ISPE Cold Chain Good Practice Guide

The Good Practice Guide is intended to provide practical guidance to assist companies in establishing good practice and achieving compliance for the transfer, packing, storing, distributing, receiving and unpacking of product requiring controlled cold conditions to maintain its safety, efficacy and quality.

Geoffrey Glauser
Director, Global Packaging Technology
Pfizer

11.40 Panel Discussion: Cooperation And Synergies Of USP <1079>, PDA TR 39, ISTA Manual 20, ISPE Good Cold Chain Guidelines And WHO Regulatory Oversight Guidance

  • Overview from each group: Objective of guidance, how unique to the other documents and industry uptake
  • Understanding what type of company uses which document for specific projects
  • Clarifying redundant aspects of cold chain qualification requirements across documents and how each individual document serves a purpose
  • Examining the process of temperature mapping and temperature profile development within each pertaining guideline
  • Discussing potential efforts to harmonize across guidance documents

Panelists:

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

Rafik H. Bishara
PhD, Technical Advisor and Chair PCCIG USA Branch
PDA

Paul Harber
Associate Engineering Consultant
Eli Lilly

Geoffrey Glauser
Director, Global Packaging Technology
Pfizer

12.30 Networking Lunch


Concurrent sessions begin: Choose Track A or B

Track A: Green and Innovative Packaging

Track B: Healthcare Cold Chain Distribution

1.45 Redesigning Long-Haul Shippers To Reduce Costs And Environmental Footprint

  • Validation of 2-30° pack-outs for domestic distribution
  • Switching from refrigerated gel packs to ambient brick gels
  • 'Go Green' initiative: Recyclable and returnable pack-outs, including reduction in foam used
  • Collecting and analyzing temperature data for five+ years to develop accurate profiles to test and qualify packaging
  • Realizing significant costs savings
  • Next steps: Other products and additional temperature ranges

Robin Turner
Director, Global Packaging Development
Medtronic

1.45 Management Of Stability Data For The Last Mile: A Case Presentation And Review Of Technical Report 46 "Last Mile"

  • Working with quality professionals to provide sufficient information to our customers and patients
  • Improving the metrics and process for evaluating product excursions for health care professionals and patients
  • Tech Report 46: Distribution from Point of Dispensing to End Use in Mail Service Pharmacy

Bella Cohen
PharmD., Global Medical Information, Global Pharmaceutical Regulatory & Medical Sciences
Abbott

2.20 From Corn To Biodegradable Packaging: Developing Expanded PLA (EPLA) For Moldable Cold Chain Shippers

As pharmaceutical manufacturers increase their focus on environmental responsibility, much of the activity has centered on recycling and reusability. As an attractive alternative, EPLA represents a potential game-changing material innovation which would alter the way we analyze return logistics and recycling needs and disposal. In addition to EPLA, expanded polystyrene resins are now available with 50—75% of post-consumer, recycled content.

  • Developing the EPLA Manufacturing Process
  • Recycled Polystyrene Raw Material Resins
  • Composting, Biodegradability and Recycling
  • Cost and Performance Attributes

Michael Hays
Vice President
Foam Fabricators, Inc.

Bob Bohne
V.P., General Manager
Cold Chain Technologies, Inc.

Stephen Good
Project Manager
Packaging Engineering & Development, Abbott

2.20 Practical Issues Faced By Front-Line Staff In The Last, But Important Leg Of The Cold Chain

  • Stability practice disparity between companies and pharmacies
  • Practical and economic issues with refrigeration of medications in the pharmacy and patient care areas
  • How stability issues contribute to medication safety challenges

Mary E. Burkhardt
MS, RPh., Medication Safety Consultant
Medication Safety Solutions

2.55 Upgrading Of Traditional Cold Chain Shipping Systems Using Custom Phase Change Materials

  • New, high performance cold chain shipping systems have become available utilizing both vacuum panel insulation and custom phase change materials
  • These new systems have greatly improved performance, but incur higher material costs, and may require reusability. Even if the ‘total cost’ is competitive, this represents a challenge because of the potential scope of the change & how it affects current operations & mind set
  • An interim approach, bridging traditional shipping systems, and new technologies will be presented to illustrate how the two can be combined in order to gradually shift an organization to these new technologies

Ben Romero
Senior Engineer, Pharma and Packaging Development
Genentech

2.55 Strengthening The Wholesaler And Pharmaceutical Manufacturer Relationship

  • Discussing the value of sharing stability and shipping data
  • Developing Quality Agreements with wholesale partners
  • Consider sharing the financial burden
  • Working together to ensure supply chain and patient safety

Chris J. Anderson
Director, Quality & Regulatory Affairs, Pharmaceutical & Medical Distribution
Cardinal Health

3.30 Solving Unique Cold Chain Challenges Through Available Technology And Innovative Reusable Container Designs While Gaining A Return On Your Investment

  • Description of thermal shipper and reusability aspects
  • Operational Qualification Testing: General approach, transit testing, thermal performance testing
  • Live shipment test results
  • Conclusions from testing results & collaboration between Pfizer and MTS
  • Qualities and initiatives of the collaboration that ensured beneficial operational and financial outcomes

Bill Mayer
Director of Engineering
Minnesota Thermal Science

Michael Kreuze
Principal Engineer
Pfizer, Inc.

3.30 Panel Discussion: Proactive And Collaborative Efforts To Ensure Cold Chain Adherence Downstream And Solid Supply Partnership

  • Understanding the current ‘state of play’: Measures and QA procedures currently in place at wholesaler and at pharmacies
  • Educating pharmacies on the cold chain requirements and solutions available
  • Addressing some of the costs involved and how to overcome budgetary issues
  • Monitoring prescription drugs – but what about diagnostic devices, OTC and drugs bought on the internet?

Moderator:

Rafik H. Bishara
PhD, Technical Advisor and Chair PCCIG USA Branch
PDA

Panelists:

Mary E. Burkhardt, MS, RPh.,
Medication Safety Consultant
Medication Safety Solutions

Bella Cohen
PharmD., Global Medical Information, Global Pharmaceutical Regulatory & Medical Sciences
Abbott

Chris J. Anderson
Director, Quality & Regulatory Affairs, Pharmaceutical & Medical Distribution
Cardinal Health

Chris Chandler Pharm D.
Quality Assurance, Consolidated Mail Outpatient Pharmacy
US Department of Veterans Affairs

4.05 Afternoon Networking Break

4.50 Roundtable Discussions

After a full day of presentations, it’s time for all participants to take an active role and get answers to specific questions. These informal discussions will provide an opportunity to exchange ideas related specifically to job functions and interests. Facilitators will present a short case study as an introduction to the 60 minute discussion and question session.

  • A) Balancing Effective Cold Chain Strategies Across the Supply Chain

    Roundtable Leader:
    Mark Wiesman
    President
    DDN

  • B) Applying the ISTA 7E Temperature Profiles & Manual 20 Certification

    Roundtable Leader:
    Jim Cox, PhD.,
    Certified Thermal Transport Auditor
    ISTA

  • C) Investigating and Validating Cost-Effective Solutions for CRT or Ambient Products

    Roundtable Leader:
    Larry Sweeney
    Senior Director, Distribution and Logistics
    Genzyme

  • D) Devising Quality Agreements with Your Wholesalers

    Roundtable Leader:
    Claude Jolicoeur
    Director of Regulatory Affairs and Corporate GMP Officer
    McKesson Canada & Pharma partner being confirmed

  • E) Packaging Design Considerations for Today's Cold Chain Challenges

    Roundtable Leader:
    Richard C. Ellinger
    Principal
    Temperature Assurance Group

  • F) New Standards Based RFID Technology Offers Increased Cold Chain Visibility and E-pedigree: Assessing the Technology, Applications and Company Experiences

    Roundtable Leaders:

    Thomas C. Reese
    Sr. Director, Business Development
    Intelleflex Corporation

    Stan Tseng
    President
    Asia Pallet Pooling

  • G) Understanding the Processes and Systems Needed to Accumulate Temperature Excursion Data Throughout the Supply Chain

    Roundtable Leader:
    Jim Bacon
    Senior Director, Global Demand Planning and Customer Operations
    Talecris Biotherapeutics

  • H) Measuring the Impact of Humidity on Product Stability

    Roundtable Leader:
    Rafik H. Bishara, PhD
    Technical Advisor and Chair PCCIG USA Branch
    PDA

  • I) Mail Order Pharmacy Cold Chain Delivery Challenges

    Roundtable Leader:
    Tina Beshears
    Medication Strategy, Director, Professional Practice
    Medco Health Solutions

  • J) Shipping Cold Clinical Supplies Internationally: Today's Logistics Considerations
    To lead this roundtable, contact courtney.becker@iqpc.co.uk

5.35 Summary Of Roundtable Discussions

6.25 Closing Remarks From Chairperson

6.30 Networking Reception In Exhibit Hall

 

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