2013 Process Validation Compliance Conference

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Education Details

Be prepared to address the new expectations for Process Validation approaches!

Significant changes demand that companies transform production and business processes.

View the Agenda ( 53 KB)

Walk Away With Practical Solutions For Your Company!

  • Participate in group application exercises
  • Benchmark approaches and discuss problem solving
  • Discuss case studies for enhancing lifecycle process understanding
  • Address expectations for application of statistics in Process Validation

Speakers

 PhotoJoanne Barrick
Advisor, Global Validation, Eli Lilly & Co, USA

 PhotoJennifer Walsh
Associate Director Manufacturing Technology, Bristol-Myers Squibb, USA

 PhotoMatthew McMenamin
Global Validation Manager, GlaxoSmithKline, USA

 PhotoMark Johnson
Quality Manager, Abbvie Inc., USA

 PhotoGary Gamboa
Senior Research Scientist, Eli Lilly & Co, USA

 PhotoStephen Tyler
Director Quality Assurance, Abbvie Inc., USA

 PhotoDeclan Greally
Pharma Specialist, Novartis, UK

 PhotoTara Scherder
Managing Director, Arlenda Inc., USA

 PhotoDavid Dolgin
Senior Quality Program Manager, AbbVie Inc., USA

Markus Kiefer, Ph.D.
Head of Global Product Allocation, Sandoz, Switzerland

 PhotoJim Bergum
President, BergumSTATS, LLC, USA

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NEW RUTGERS TOUR OPTION ADDED!Tour the Continuous Pharmaceutical Advanced Manufacturing Laboratory (CpAML) at Rutgers University

Wednesday, 8 October
Bus departs at 18.30
Limited space available

Cost is $30 including transportation, tour and dinner.
Register by emailing ISPE Members Services at ask@ispe.org or calling +1-813-960-2105.

The ISPE tour on October 9th will consist of the process development laboratories as well as highlight The Continuous Pharmaceutical Advanced Manufacturing Laboratory (CpAML) located at the headquarters of the ERC for Structured Organic Particulate Systems (C-SOPS) within the Department of Chemical and Biochemical Engineering at Rutgers University. The CpAML laboratory houses a full scale 30-70 Kg/hr automated continuous direct compaction line and development of similar scale wet and dry granulation lines is in progress. Additionally, the materials characterization techniques and control development techniques used in designing a continuous process will be highlighted.

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Sessions and Speakers

    • Introduction: PV Lifecycle Basics and the Importance of Variability; ISPE PQLI PV Team Activities; Interactive Benchmarking
      • Joanne Barrick, R.Ph., Advisor, Global Validation, Eli Lilly & Co, USA
        Process Validation Introduction
    • Statistically Determined Acceptance Criteria and Sampling Plans for PPQ
      • Mark Johnson, Principal Research Statistician, AbbVie Inc., USA
        Statistically Determined Acceptance Criteria and Sampling Plans for PPQ
    • Group Exercise: Determining PPQ Criteria and Sampling Plan
      • Expectations/Deliverables From PV Stage 1- Process Understanding, Control Strategy, Variability - Case Study
        • Matthew McMenamin, Global Validation Manager, GlaxoSmithKline, USA
          Linking Stage 1 and Stage 2 in Process Validation
      • Case Study: Application of Lifecycle Approach to PV to Large Molecule Parenteral Product
        • Gary Gamboa, Sr. Research Scientist, Eli Lilly, USA
          Case study on Application of the Lifecycle Approach to PV for a New Biologic Product
      • Statistical/Risk Based Means to Determine the Number of PPQ batches-ISPE PQLI PV Team Discussion Paper Approaches
        • Joanne Barrick, R.Ph., Advisor, Global Validation, Eli Lilly & Co, USA
          Determine Number of PPQ Batches
      • Exercise: Determining the Number of PPQ Batches
        • PV Expectations Outside USA
          • Stephen Tyler, Director Quality Assurance, AbbVie, USA
            PV Expectations Outside USA
        • Use of ASTM E2709 and 2810 for Validation and Release
          • James Bergum, Ph.D., President, BergumSTATS, LLC, USA
            Utilizing ASTM Standards for Validation and Batch Release Decisions
        • Exercise: Applying USP limits and ASTM Standards to a Data Set
          • Facilitator: James Bergum, Ph.D., President, BergumSTATS, LLC, USA
        • Case Study: Applying Different Statistical Approaches for Same Data Set - Impact on PV Results (ISPE Discussion Paper)
          • Tara Scherder, Managing Director, Arlenda Inc., USA
            Case Study Applying Different Statistical Approaches for Same Data Set – Impact on PV Results
        • Impact of Lifecyle Approach on Legacy Products- Case Study
          • Declan Greally, Pharma Specialist, Novartis, United Kingdom
            PV Lifecycle: Implementation approach for Legacy Biological Products
        • Challenges in Implementing the Lifecycle Approach to PV for Generic Manufacturing
          • Markus Kiefer, Ph.D., Head Manufacturing Science & Technology, Sandoz AG, Global Technical Operations, Switzerland
            Challenges in Implementing the Lifecycle Approach to PV for Generic Manufacturing
        • Panel Discussion - Most Difficult Challenges to Lifecycle Approach Implementation
        • Application of Lifecycle Approach to PV to Large Molecule/Biologics Processes (ISPE Discussion Paper)
          • David Dolgin, Senior Quality Program Mgr, AbbVie Inc., USA
            Application of the Lifecycle Approach to PV to Biotech Products
        • PV Stage 3 - Making PV Stage 3a Decisions
          • Joanne Barrick, R.Ph., Advisor, Global Validation, Eli Lilly & Co, USA
            PV Stage 3 - Making PV Sage 3 Decisions
        • Determining a Stage 3a Decision
        • Business Benefits of Using a PV Lifecycle Approach - Return of Investment Model
          • Jenn Walsh, Associate Director Mfg Tech, Bristol-Myers Squibb, USA
            Benefits of Using a Lifecycle Approach - ROI Model
        • Next Actions, Benchmarking Opportunity, Remaining Issues and Challenges, Future Discussion Topics
          • Joanne Barrick, R.Ph., Advisor, Global Validation, Eli Lilly & Co, USA
          • Jenn Walsh, Associate Director Mfg Tech, Bristol-Myers Squibb, USA

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      Thank you to our Top Tier Sponsors

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      • Host Sponsor

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