QbD Updates from ISPE 2013 (Washington, DC) Conference

I will be attending ISPE 2013 (Nov. 3-6) starting this Sunday.

Although I won’t be presenting this time, I will share with the QbDWorks Community,

Quality-by-Design related updates from the conference.

Some key players of QbD in Biotech are attending:

  • Janet Woodcock (Director of CDER, FDA )
  • Steven Kozlowski  (Director, Office of Biotechnology Products, FDA)
  • Lynne Kruemmen (VP, Genentech, QbD head)
  • Christine Moore  (Director, ONDQA, FDA)

Overall, I will try to share:

  • Latest QbD Benchmark of other BioPharma companies
  • QbD Suggestions, Challenges, Opportunities from FDA
  • Industry and Regulatory Network of QbD pioneers

Please take a look at the agenda below.

If you have any person that you’d want to meet or session that you’d want to attend, but cannot in person,

please let me know by sending an email sun_at_qbdworks.com or leaving a comment.

If I happen to be available at the time, I’ll try to cover it.

 

Also From Nov. 7~16, I will be traveling to Korea to teach “Design for Excellence” workshop at Siemens Healthcare.

 

ISPE 2013 Program Schedule (Source: http://www.ispe.org/2013annualmeeting)

Sunday, 3 November
13:30 – 17:00 Biomanufacturing

  • Leader: Jeffery Odum, CPIP, Director Ops, Biotech Lead, IPS, USA
  •  Ali Afnan, PhD, President, Step Change Pharma Inc, USA
  •  Peter Bigelow, President, XCell Strategic Consulting, LLC., USA
    If Single use is the answer, why isn’t everyone using it?
  •  Parrish Galliher, Chief Technology Officer, Upstream, Xcellerex LLC, USA
    The future of Biomanufacturing: Faster, Better, Cheaper
  •  Joshua Hays, Associate Director of Upstream Business Development, EMD Millipore, USA
    If single use is the answer, why isn’t everyone using it?
  •  Paul Smock, Sr. Director, Technical Quality, MedImmune LLC, USA
    Biomanufacturing: Challenges for Controlled Non-Classified (CNC) Multi-Product Drug Substance Facility Design and Operation
  •  Andre Walker, CPIP, Director, Mfg Sciences, Biogen Idec, USA
    Bombs, Batteries or Baby Carriages: We can Learn from Other Industries
  •  Thomas Warf, Chief, Infrastructure Branch, HHS/BARDA, USA
    HHS Centers for Innovation in Advanced Development and Manufacturing
13:30 – 17:00 New EU GMPs, Risk-MaPP and You • Are You Ready?

  • Leader: Stephanie Wilkins, PE, President, PharmaConsult US Inc, USA
    Setting Limits – EMA/Risk-MaPP Approaches Applying Health-Based Limits to determine if shared facilities can be used
  •  Nuah Al-Hafez, TEVA Canada, Canada
    Teva Global Quality Risk Management Program – Cross Contamination
  •  Pamela Kelberer, EHS Officer, PII, USA
  •  Joseph Payne, TEVA USA, USA
    Teva Global Quality Risk Management Program – Cross Contamination
  •  George Petroka, CIH, CSP, Principal, IES Engineers, USA
    QUANTIFYING CROSS-CONTAMINATION IN A MULTI-PURPOSE FACILITY: EXPERIMENTAL DESIGN AND INTERPRETATION
13:30 – 17:00 Best Practices for Single Use Technologies

  • Leader: Pietro Perrone, PE, Mobius Single-Use Sys Eng, EMD Millipore Corporation, USA
  •  Ross Acucena, Regulatory Consultant, EMD Millipore, USA
    Best Practices in Qualification and Validation of Single-use Systems for Aseptic Final Filling
  •  Jean-Marc Cappia, Group VP Mktg Product Mgmt, Sartorius Stedim Biotech, France
    Validation of Single-use Systems: Extractables and Leachables
  •  Niels Guldager, CPIP, Senior Technology partner, NNE Pharmaplan A/S, Denmark
  •  Christian Matz, Global Project Manager, F. Hoffmann-La Roche Ltd, Switzerland
    Best Practices in Qualification and Validation of Single-use Systems for Aseptic Final Filling
  •  Robert Munday, VP Technical Operations, CMC Icos Biologics, Inc., USA
    Implementation of Single Use Technologies
  •  David Wolton, Biopharma Consultant, PM Group, Ireland
    Standardization of Disposables Design
13:30 – 17:00 Asset Reduction

  • Leader: Terry Jacobs, AIA, Partner, Jacobs/Wyper Architects, LLP, USA
  •  Sara Gates, Senior Interior Designer, Jacobs/Wyper Architects, LLP, USA
  •  Gualberto Medina, Executive VP Brokerage Svcs, CBRE Group, USA
    Repostioning of Life Sciences Office and Laboratory Spaces
  •  William Wiederseim, President/CEO, PharmaBioSource, USA
    The State of the Industry-Too Much Space
13:30 – 17:00 The Use of Metrics in the Pharmaceutical Industry: A Practical Approach for Computerized System Compliance and Validation
Due to unforeseen circumstances, this session is CANCELLED. Handouts of presentations will be available after the conference.
13:30 – 17:00 Clinical Data and Systems

  • Leader: Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
    How to combine 21 CFR Part 11, EU-GMP Annex 11 requirements and how to apply these to local and global GCP systems
  • Leader: Eric Staib, Sr. Director IT Quality, RPS – ReSearch Pharma Services, USA
    How to combine 21 CFR Part 11, EU-GMP Annex 11 requirements and how to apply these to local and global GCP systems
  •  Jonathan Helfgott, Acting Associate Director for Risk, Science, Intelligence & Prioritization, FDA/CDER/Office of Scientific Investigations, USA
    Today’s FDA perspective on the role of electronic source data used in eClinical Systems
  •  Frank Henrichmann, Technical Quality Manager, PAREXEL International, Germany
    Agile Project Management for Implementation of Regulated (GCP and GMP) Systems
  •  Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
    How to combine 21 CFR Part 11, EU-GMP Annex 11 requirements and how to apply these to local and global GCP systems
  •  Marina Mangold, Head of EClinical Solutions & Data Management, Alcedis GmbH, Germany
    Agile Project Management for Implementation of Regulated (GCP and GMP) Systems
  •  Maximilian Stroebe, QA eCompliance Manager, Novartis Vaccines & Diagnostics GmbH, Netherlands
    Audit Trail Review in GCP and GMP Systems – A Regulatory Requirement?
  •  Dieter Wachtmann, Sr Mgr Regulatory Intelligence, Parexel International, Germany
    Today’s FDA perspective on the role of electronic source data used in eClinical Systems
13:30 – 17:00 Project Execution in Emerging Markets

  • Leader: James Hamilton, Business Development, Fluor Corporation, USA
  •  Thomas Hendricks, Vice President of Operations, Fluor Engineering & Construction Ltd, China
    Project Execution in Emerging Markets
  •  John Hyde, Chairman & Founder, Hyde Engineering + Consulting Inc, USA
    State of the Art Biopharmaceutical Manufacturing in the Developing World
  •  Niranjan Kulkarni, PhD, Operations Specialist, CRB Consulting Engineers, USA
    Designing a Lean Facility
  •  Kristina Pumphrey, PE, Ops Improvement Specialist, CRB Consulting Engineers, Inc., USA
    Designing a Lean Facility
  •  Josef Trapl, Tech Mgr Pharma-Medical Devices, M+W Group, Germany
    Advanced Facility Design in Emerging Markets
13:30 – 17:00 Institutionalizing the Process Improvement Mindset by Utilizing Operational Excellence

  • Leader: Elizabeth Zybczynski, Sr. Manager, Baxter Healthcare Corp, USA
  •  Prabir Basu, PhD, Consultant, USA
    What is Operational Excellence?
  •  Richard Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA/CDER, USA, FDA/CDER, USA
    Regulatory Findings of Variability in Industry
  •  Theodora Kourti, PhD, Senior Technical Director, GlaxoSmithKline, United Kingdom
    Leveraging PAT to enhance OpEx
  •  Grace McNally, Consumer Safety Officer, FDA/CDER/Office of Compliance, USA
  •  Chris Stevenson, Sr Mgr Quality Inno. & Lifecycle Mgmt, Baxter Healthcare Corp, USA
    Implementation of Quality by Design (QbD) Concepts for a Legacy Immunoglobulin Product
13:30 – 17:00 Science-Engineering-Compliance: Essentials of GMP Manufacturing – A Young Professionals Track – Understanding Your Industry

  • Leader: Brody Stara, Process Engineer, CRB Consulting Engineers, USA
  •  Timothy Fields, Vice President, Quality, Protein Sciences Corporation, USA
    Regulatory Concepts of Pharma, Medical Device and Biotech
  •  Alice Redmond, Ph.D., Vice President, Commissioning Agents Inc, Ireland
    Manufacturing Techniques in Traditional and Biotech Facilities
  •  Jonathan Romero, Associate Director Global Eng, Biogen Idec, USA
    Engineering Scale-up Challenges for Manufacturing Mammalian Cell System for producing Biologics
  •  Andre Walker, CPIP, Director, Mfg Sciences, Biogen Idec, USA
    Manufacturing Techniques in Traditional and Biotech Facilities
13:30 – 17:00 We the People: Managing People to assure Quality throughout the Project Management Lifecycle

  • Leader: Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA
  • Leader: James McGlade, Senior Project Manager, Clark Nexsen, USA
15:00 – 15:45 Networking Break in Exhibit Hall
17:00 – 19:00 Sunday Welcome Reception in Exhibit Hall
Monday, 4 November
09:00 – 12:00 Plenary Session
2013 FOYA – Introduction of Category Winners and Announcement of the Overall Winner

  •  Nancy Berg, President and CEO, ISPE, USA
    Strategic Direction for ISPE
  •  Damian Greene, Global Network Strategy Leader, Zoetis, Belgium
    The Role of ISPE as a Global Organization
  •  Julie Kim, General Mgr-BioTherapeutics, Baxter Healthcare Corporation, USA
    Importance of the Baxter Covington Facility to the Industry and Patients
  •  Janet Woodcock, Director, FDA/DHHS/Accounting Operations, USA
    Update on “Office of Pharmaceutical Quality,” What’s new in CDER and how it affects your process.
10:00 – 10:30 Networking Break
12:00 – 14:00 Lunch in Exhibit Hall
14:00 – 17:30 QbD and CPV for Biotech: How To Advance Implementation

  • Leader: Ranjit Deshmukh, PhD, Sr. Director, AstraZeneca, USA
    Industrial Case Study: Continued Process Verification (CPV) for Biotech Product (BPOG Collaboration)
  • Leader: David Dolgin, Senior Quality Program Mgr, AbbVie Inc., USA
    Process Validation for Biotech Products
  •  Ranjit Deshmukh, PhD, Sr. Director, AstraZeneca, USA
    Industrial Case Study: Continued Process Verification (CPV) for Biotech Product (BPOG Collaboration)
  •  David Dolgin, Senior Quality Program Mgr, AbbVie Inc., USA
    Process Validation for Biotech Products
  •  Richard Gunderlock, Dir, Corp Validation Services, Astra Zeneca Global Ops Supply, USA
  •  Stephen Tyler, Director Quality Assurance, AbbVie, USA
    Points to Consider for Process Validation for non-US regions
14:00 – 17:30 Individual Technical Presentations I – Cost-Saving Facilities Projects

  • Moderator: John Gilroy, PE, General Manager-CM, IPS, USA
    Integrated Project Delivery: Minimizing Risk and Reducing Overall Delivery Schedule and Costs
  •  Vincent Cebular, Senior Vice President, IPS, USA
  •  John Gilroy, PE, General Manager-CM, IPS, USA
    Integrated Project Delivery: Minimizing Risk and Reducing Overall Delivery Schedule and Costs
  •  Klaus Hermansen, Senior Technology Partner, NNE Pharmaplan A/S, Denmark
    Case study: Design of Vaccine Multiproduct facility – Challenges and Benefits!
  •  Kiu Leung, Life Science Consultant, ProcessArc,
  •  Vito Pirrera, Vice President of Operations, Vantage Consulting Group, USA
    Keys to Implementing a Successful Serialization Project
  •  Shahbaz Shahbazi, Prinicpal, Process ARC, USA
    Product Complaint Investigations – The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries
  •  Steve Shank, Senior Process Engineer, Process Plus, USA
  •  John Wentz, P.E., Dir., Water/Wastewater Svcs, ProcessPlus,
    Wastewater Cost Savings by Design
14:00 – 17:30 Individual Technical Presentations II – Validation Trends

  • Moderator: Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
    Validation of Computerized Systems in a Global GCP Cloud: What can manufacturing and the GMPs learn?
  •  John Fisher, President, Unidec, USA
    Extending the Life-Cycle of GMP Validated Legacy Systems
  •  Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
    Validation of Computerized Systems in a Global GCP Cloud: What can manufacturing and the GMPs learn?
  •  Martin Preis, Director, Tech Quality Mgmt, Parexel International, Germany
    Validation of Computerized Systems in a Global GCP Cloud: What can manufacturing and the GMPs learn?
  •  James Schweitzer, Director, Commercial Technology Services, Vision Point Systems Inc., USA
    Lessons Learned from Validating a Cloud-based IRT system using the GAMP 5 Risk-based Approach
  •  Luciano Tavares, Commercial Director, NNE Pharmaplan, Brazil
    Biotechnology Scenario on Brazilian Market
  •  Connor White, Engineer I, Hyde Engineering + Consulting Inc, USA
    Development of TOC Analytical Methods
14:00 – 17:30 Individual Technical Presentations III – Lifecycle Processes and Production

  • Moderator: Klaus Fritsch, Manager Compliance, Mettler Toledo AG, Switzerland
    GWP – The Scientific Global Standard for Risk-based Lifecycle Management of Weighing Equipment
    GWP® – The scientific global standard for risk-based lifecycle management of weighing instruments
  •  Michael Anderson, Executive VP – COO, Total Facility Solutions, Inc, USA
    Collaborative Contracting for Project Success
  •  Steve Buckingham, Engineer II, Hyde Engineering + Consulting Inc, USA
    Visual Image Processing for Bench Scale Cleanability Studies
  •  Albert Dyrness, Vice President, ADVENT Engineering Services, Inc., USA
    Leveraging the ASME-BPE Standard for Compliance and Continuous Improvement
  •  Klaus Fritsch, Manager Compliance, Mettler Toledo AG, Switzerland
    GWP – The Scientific Global Standard for Risk-based Lifecycle Management of Weighing Equipment
    GWP® – The scientific global standard for risk-based lifecycle management of weighing instruments
  •  Frank Henrichmann, Technical Quality Manager, PAREXEL International, Germany
    Agile Project Management for Implementation of Regulated Systems
  •  David Marks, P.E., Principal, DME Alliance Engineering Consultants, USA
  •  Kelly Scalva, Engineer II/CORE Lab Lead, Hyde Engineering + Consulting Inc, USA
    Visual Image Processing for Bench Scale Cleanability Studies
14:00 – 17:30 “In Order to Form a More Perfect Project” – Managing Risk To Assure Quality throughout the Project Management Lifecycle

  • Leader: Brian Beck, Manager / TL – Project Eng, Zoetis Global Mfg and Supply, USA
  • Leader: Patricia Melton, BSc, PhD, MBA, Managing Director, MIME Solutions Ltd, United Kingdom
    PM Track: Sesseion 802 Exercise Handout
  •  Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA
  •  James McGlade, Senior Project Manager, Clark Nexsen, USA
  •  Alfred Penfold, Director, Global Engineering, Pfizer, United Kingdom
14:00 – 17:30 Executive Series – ISPE Research Initiatives

  • Leader: Michael Arnold, RPh, Sr. Dir., Strategic Partnerships, Invest. Prods, Pfizer Global Clinical Supplies, USA
  •  John Berridge, PhD, CChem, FRSC, Pharma Quality & Reg., -, United Kingdom
    Overview: ISPE’s Drug Shortage Initiative
  •  Ken Getz, Senior Fellow, Tufts University Medical School Center for the Study of Drug Development, USA
    Patient Survey – A read out on the ISPE IP COP Survey on Patient Experience related to Investigational Medicinal Products (IMPs)
  •  Karleen Kos, Vice President of Member and Industry Services, ISPE, USA
    ISPE’s 2014 Research Priorities
  •  Stephen Mahoney, Sr Dir, Head, Compl. Ext. Collaboration, Genentech Inc, USA
    CMC Authorization
  •  Christine Milligan, Global Director, Catalent Pharma Solutions, United Kingdom
    Patient Survey – A read out on the ISPE IP COP Survey on Patient Experience related to Investigational Medicinal Products (IMPs)
  •  Sam Venugopal, Director, PricewaterhouseCoopers LLP, USA
    Operations Team Update
  •  Bryan Wright, ISPE Regulatory Advisor, United Kingdom
    Outcomes from EMA Workshop on Drug Shortages
14:00 – 17:30 Executive Series – Baxter Facility Case Study

  • Leader: Brien Johnson, Vice President, Program Mgmt, Baxter Healthcare Corp., USA
    Saving and Sustaining Lives Worldwide
  • Leader: Jerald Polly, Principal, Flad Architects, USA
    Creating Solutions and Building the A/E Team
  •  Samuel Kitchell, VP Engineering, Baxter Healthcare Corporation, USA
    Team Development
  •  Ken Meschke, PE, Principal, Affiliated Engineers Inc., USA
    Creating Solutions and Building the A/E Team
  •  Jerald Polly, Principal, Flad Architects, USA
    Creating Solutions and Building the A/E Team
  •  Eric Schnake, Engineering Director, Baxter Healthcare Corp, USA
    Implementation: The Covington Site
  •  Ryan Schroeder, Regional Leader, CRB Consulting Engineers Inc, USA
    Process Design & Innovation
  •  Steven Shelden, Vice President of Operations, Yonkers Industries Inc, USA
    Construction
  •  Scot Thomas, Program Director, Baxter Healthcare Corp, USA
    Implementation: The Covington Site
14:00 – 17:30 Executive Series – Facilities of the Future: Innovation, Standardization and Modularization

  • Leader: Pär Almhem, President, ModWave and ModularPartners, USA
    Competing in a Global Market – Innovation, Standardization and Modularization
  •  Mark Bell, Vice President of Operations, Gallus BioPharmaceuticals, LLC, USA
    The Future of Biologics Contract Manufacturing
  •  Douglas Hausner, Assoc Dir. Business Dev Ind. Relations, Rutgers University, USA
    Continuous Solid Oral Dose Manufacturing
  •  Detlef Kehm, PhD, VP, Maintenance and Engineering Services, Grifols Therapeutics Inc., USA
    Case Study: An Innovative Approach to Facilities Delivery
  •  Robert Snow, CPIP, Senior Engineer Biologics Dev, Genzyme Corp a Sanofi Company, USA
    The Integrated Continuous Biomanufacturing Platform
14:00 – 17:30 Executive Series – Quality Metrics Outcomes: Conversations with FDA

  • Leader: Cynthia Salamon, VP, Global Quality Services, Bristol-Myers Squibb, USA
    Out of Specification / Laboratory Failure Investigation Rates
  •  Lorraine McClain, Sr Dir. Quality Compliance, Teva Pharmaceuticals, USA
    Quality Metrics Proposal: Batch Rejection Rate 
    Quality Metrics a PQLI Initiative – Leading Indicators
  •  Lorraine McClain, Sr Dir. Quality Compliance, Teva Pharmaceuticals, USA
    Quality Metrics Proposal: Batch Rejection Rate 
    Quality Metrics a PQLI Initiative – Leading Indicators
  •  Cynthia Salamon, VP, Global Quality Services, Bristol-Myers Squibb, USA
    Out of Specification / Laboratory Failure Investigation Rates
  •  Lorraine Thompson, Quality Sys Implementation Dir, Novartis, USA
  •  Russell Wesdyk, Science Coordinator, US FDA, USA
14:00 – 17:30 Science-Engineering-Compliance: Essentials of GMP Manufacturing – A Young Professionals Track – Integrating Quality Into Your Project

  • Leader: Brody Stara, Process Engineer, CRB Consulting Engineers, USA
  •  Nikolas Burlew, VP Quality Systems, Clinipace, Inc., USA
    Essential Elements of a Quality Management System
  •  John Hannon, Vice President, SE Region, Commissioning Agents Inc, USA
    Effective Deployment of Information Management Systems
  •  Michael Kimball, Executive Dir, Transdermal Dev, Actavis plc, USA
    Quality by Design
  •  James Lambert, Baxter,
    The Structure of Risk Management
  •  Dawn Tavalsky, Director, Genzyme Corp., USA
    Essentials of Process Validation including Case Studies
14:00 – 17:30 Investigational Products – Defining the New Landscape of Clinical Supplies: Share Industry Findings – Patient Survey

  • Leader: Michelle Foust, PharmD, Director New Product Dev, Almac Clinical Services, USA
  •  Ken Getz, Senior Fellow, Tufts University Medical School Center for the Study of Drug Development, USA
    Patient Survey and Case Study Discussion: Findings and Implications
  •  Michael Ku, PharmD, MBA, VP, Global Clinical Supply, Pfizer Inc, USA
    Patient-Focused Clinical Supply Supply Study
  •  Christine Milligan, Global Director, Catalent Pharma Solutions, United Kingdom
    Patient Survey – A read out on the ISPE IP COP Survey on Patient Experience related to Investigational Medicinal Products (IMPs)
  •  Robert Pizzie, PhD, Associate Vice President, Merck, USA
14:00 – 17:30 Maintenance and Reliability Programs and the Evolution into World Class Best Practices

  • Leader: Marie Getsug, CMRP, Engineer, Commissioning Agents, Inc., USA
    FDA’s Perspective on Maintenance & Reliability Programs and the Evolution into World Class Best Practice
  •  Matthew Sparks, Merck,
    Transitioning from Craft Based to Procedure Based Maintenance & a Silver Bullet for Results
15:00 – 15:45 Networking Break in Exhibit Hall
19:30 – 22:00 YPREC-Young Professional’s Event
Tuesday, 5 November
07:00 – 08:00 Quality Metrics Breakfast
08:00 – 11:30 Executive Series-The FDASIA Transition Point for Pharmaceutical Quality Systems (PQS) and cGMP

  • Leader: Joseph Famulare, VP Global Compliance, Genentech Inc, USA
    Benefits of Implementation for an Industry Standpoint of PQS, how quality systems informed the ISPE drug survey
  • Leader: Richard Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA/CDER, USA, FDA/CDER, USA
    FDA’s Next Steps for Quality Systems for Pharmaceuticals following FDASIA
  •  Barbara Allen, PhD, Sr Director, Global Quality Sys, Eli Lilly SA, Ireland
    How management uses PQS to ensure consistent operations and reliable supply, and as a risk Mitigation strategy
  •  Zena Kaufman, Sr. VP Global Quality, Hospira, Inc., USA
  •  Robert Sausville, Director, Division of Case Management, Office of Compliance and Biologics Quality, CBER, USA
    How FDA Communicates expectations for the Implementation of Quality Systems via its cGMP Inspection Compliance programs and via Regulatory Communications with Firms
08:00 – 11:30 “Establish plans to assure Project Tranquility” – Managing Project Initiation and Delivery Planning to assure Quality throughout the Project Management Lifecycle

  • Leader: John Honey, Head of Technical Site Services, Roche, China
  • Leader: Alfred Penfold, Director, Global Engineering, Pfizer, United Kingdom
08:00 – 11:30 Managing and Assuring Quality

  • Leader: Alex Brindle, Ph.D., Managing Partner, NNE Pharmaplan, USA
  •  Ferdinando Aspesi, VP, Sr Advisor To Group, Novartis, USA
    Managing and Assuring Quality: From Development through Manufacture
  •  Jean-Marie Geoffroy, Ph.D., VP Quality, Hospira, USA
  •  Duncan Low, PhD, Scientific Executive Director, Amgen Inc, USA
    Eye of Newt and Toe of Frog – Understanding the Witches Brew of Raw Materials
  •  Kelly Swinney, Associate Director, Vertex Pharmaceuticals, Inc., USA
08:00 – 11:30 Advanced Aseptic Processing I

  • Leader: Ryan Hawkins, VP of Operations & COO, Cook Pharmica, USA
  • Leader: Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA
    2012 Global Barrier Isolator Survey-Results and Trends
  •  Hite Baker, Principal Process Engineer, DME Alliance Engineering Consultants, USA
    Isolator-Based Sterile Manufacturing Facilities: A Comparison of Conventional Stainless-Steel versus Single-Use-Disposable Technology Implementation
  •  Sterling Kline, R.A., Vice President, IPS, USA
08:00 – 11:30 FOYA I

  • Leader: Kelly Keen, Senior Project Manager, Genentech Inc., USA
  •  Marcus Habluetzel, Senior Project Manager, F. Hoffmann-LaRoche Ltd, Switzerland
    FOYA Category Winner: Project Execution
  •  Brent Hill, Director of Automation, AstraZeneca, USA
    Redesigning Egg-based Bulk Vaccine Manufacturing
  •  Jack Kane, Associate Director, Project Eng, Biogen Idec, USA
    Flexible Volume Manufacturing Project, Biogen Idec
  •  Mark Proctor, Director, MS&T, AstraZeneca, United Kingdom
    Redesigning Egg-based Bulk Vaccine Manufacturing
08:00 – 11:30 Data Integrity I: Ensuring Data Integrity throughout the Pharmaceutical Lifecycle

  • Leader: Monica Cahilly, President, Green Mountain Quality Assurance, LLC, USA
  • Leader: Michael Rutherford, Consultant, Lab Systems, Eli Lilly & Co, USA
    The Importance of Data Integrity When Performing Data Reviews and Investigations
  •  Jonathan Helfgott, Acting Associate Director for Risk, Science, Intelligence & Prioritization, FDA/CDER/Office of Scientific Investigations, USA
    E-Source Data Guidance and GCP Data Integrity
  •  Karen Takahashi, Compliance Officer, FDA, USA
    Assuring Data Integrity and Current FDA Enforcement Related to Data Integrity Problems
08:00 – 11:30 Lean Principles: QC Labs

  • Leader: Javier Garay, Principal-Architectural Designer, Flad Architects, USA
    Lean From a Design Perspective
  • Leader: James Gazvoda, Principal, Flad Architects, USA
    Lean From a Space Planning Perspective
  •  Emilio Moia, Engineering Manager, Jacobs Italia S.p.A., Italy
    Lean From an Energy / Systems Perspective
  •  Tom Reynolds, BSM, Ireland
    Lean in a Lab Environment
  •  Pamela Thurtle, Div. Continuous Improvement Manager, Novartis, United Kingdom
08:00 – 11:30 Securing the Global Drug Supply Chain – Protecting Patients and Your Business

  • Leader: Brian Johnson, Sr Dir Supply Chain Security, Pfizer, USA
    Introdcution to Rx360 and the Supply Chain Security Challenge
  • Leader: Raymond Scherzer, PE, PM SET, LLC, USA
  •  Thomas Christl, Acting Director, ODSIR, FDA, USA
  •  Brian Johnson, Sr Dir Supply Chain Security, Pfizer, USA
    Introdcution to Rx360 and the Supply Chain Security Challenge
  •  Peggy Staver, Director, Product Integrity, Pfizer Inc, USA
  •  Tara Steketee, Assoc Dir, Product Integrity, Merck & Co Inc, USA
  •  Timothy Valko, Executive Director, Operations Risk Management, Amgen Inc, USA
    Comprehensive Pharmaceutical Supply Chain Security Programs
08:00 – 11:30 PAT Based Process Control for Batch and Continuous Process – Ultimate Step in Real Time Release

  • Leader: Sharmista Chatterjee, PhD., QbD CMC Lead, FDA, USA
  • Leader: Theodora Kourti, PhD, Senior Technical Director, GlaxoSmithKline, United Kingdom
  •  Bryan Looze, Senior Engineer, Amgen, USA
    PAT-based Control on BioPharma
  •  John Mack, Principal Engineer, Perceptive Engineering Ltd, United Kingdom
    PAT based Advanced Process Control and Monitoring applications for batch and continuous crystallization.
  •  Robert Perks, MSc CEng, Engineering Specialist, Baxter Healthcare Corp, USA
    Manufacturing Tracking and Control Systems – State of the Art Practice for Parametric Release Sterilization Programs
  •  Martin Warman, Senior Manager/Team Leader, Vertex Pharmaceuticals, USA
    Process Control in Continuous Processes
08:00 – 11:30 Regulatory Harmonization in Asia Pacific Countries – Challenges to Multi-National companies

  • Leader: Chi-wan Chen, PhD, Executive Director, Pfizer Inc., USA
    Session 209 Introduction
  •  Min Gui, Assoc Director, Regulatory, Bristol-Myers Squibb Co., USA
    Challenges in New Drug Application (NDA)
  •  Rebecca Komas, Dir CMC Advocacy-Strategy, GlaxoSmithKline, USA
    What’s New with the Pharmacopeias?
  •  Maurice Parlane, Principal/Director, New Wayz Consulting Ltd, New Zealand
    Update on Good Manufacturing Practice (GMP) and PIC/S in the Asia Pacific Region
  •  Xiling Song, Associate Regulatory Program Director, Genentech, A Member of Roche Grp, USA
    Recent Trends in Investigational Drug Application (IND) in Asia Pacific Countries
  •  Susan Stolz, Principle Reg. Consultant, Eli Lilly & Co, USA
    Comparison of Asia Markets – Case Study for the Landscape in Post-Approval Changes/Variations
  •  Robert Tribe, AP Reg. Affairs Advisor, ISPE, Australia
    Update on Good Manufacturing Practice (GMP) and PIC/S in the Asia Pacific Region
08:00 – 11:30 Process Validation: Bringing the Lifecycle Apporach to Practical Global Reality and Beyond

  • Leader: Joanne Barrick, Advisor, Global Validation, Eli Lilly & Co, USA
  •  Grace McNally, Consumer Safety Officer, FDA/CDER/Office of Compliance, USA
  •  Jenn Walsh, Associate Director Mfg Tech, Bristol-Myers Squibb, USA
08:00 – 11:30 Investigational Products – Defining the New Landscape of Clinical Supplies: Risk Management and the Supply Chai – Part I

  • Leader: Neal Gordon, Ph.D., Director, Project Management, Merck, USA
  • Leader: Lorann Morse, SVP, Clinigen CTS, Clinigen, USA
  •  Richard Gaeto, VP Corporate Operations, Dendreon Corp, USA
    From Autologous Cell Collection To Personalized Immunotherapy in 4 Days: Dendreon’s Supply Chain, A Case Study
  •  Catherine Hall, Assoc Dir Clinical Operations, Biogen Idec, USA
    Driving the Last Mile toward Customer Focus in Clinical Trials
  •  John Holland, Sr. VP-Research-Business Dev, AMC Health, USA
    Crowd Sourcing and Telemonitoing: “Better Data at Lower cost”
  •  Darlette Luke, RPh, IDS Pharmacy Manager, University of Minnesota Medical Center Fairview,
  •  David Northrup, Accenture Inc., United Kingdom
    Strategies in Controlling Risk in the Clinical Supply Chain
08:00 – 11:30 Science-Engineering-Compliance: Essentials of GMP Manufacturing – A Young Professionals Track – Critical Components To Successful Manufacturing

  • Leader: Joseph Manfredi, President, GMP Systems Inc, USA
    Facilities
  •  Daniel Deese, PE, Mechanical Engineer, CRB Consulting Engineers Inc., USA
    Utilities – Energy saving options, case studies
  •  Marcel Dion, Director of Marketing, STERIS Corp, Canada
    Principles of Steam Sterilization and Common Mistakes
  •  Kevin Rawls, Auto System Integrator II, Avid Solutions Inc, USA
    Automation Applications in the Pharmaceutical Industry
09:15 – 10:00 Networking Break in Exhibit Hall
11:45 – 13:15 Membership Lunch
12:00 – 13:00 Exhibitor Lunch with Speaker
13:30 – 15:00 PHARMA CAFE-Cutting Edge Technologies

  • Leader: Nicholas Haycocks, Senior QA Specialist, Amgen Inc., USA
  • Leader: Randolph Leinhauser, Associate Director, Engineering, Merck, USA
  •  Bikash Chatterjee, President & CTO, Pharmatech Associates, USA
  •  Oliver Stauffer, COO-VP Inspection Technologies, Packaging Tech & Inspection LLC,
    The Path to Package Integrity Non-Destructive Package Inspection Technologies
  •  Carmine Stropoli, PE, Pharma Technology Director, Middough Inc, USA
    Non-Contact Measurement for Filled Weight Control
  •  Randy Turner, Technical Director, Swan Analytical USA, USA
    TOC Innovations for Direct UV Oxidation in Pharma
13:30 – 17:15 Risk Based C&Q

  • Leader: Frank Van Der Steen, Owner/Principal Consultant, FVCS, Netherlands
  • Leader: Steven Wisniewski, Principal Consultant, Commissioning Agents, Inc., USA
  •  Joerg Block, PS-TS-KM-Technical Compliance, Bayer HealthCare AG, Germany
    Risk Based C&Q for Standard Equipment Qualification in a Global 2-D Matrix Program
  •  Machteld Deconinck, Principal Engineer, Johnson and Johnson, Belgium
    Lessons Learned about Planning
  •  David Dolgin, Senior Quality Program Mgr, AbbVie Inc., USA
    Science and Risked Based C&Q
  •  Nicholas Haycocks, Senior QA Specialist, Amgen Inc., USA
    Practical Application of a Risk Based Approach, and Lessons Learned
  •  Brian Pochini, CPIP, Principal Engineer, Genzyme, A Sanofi Company, USA
  •  Ghenet Simpson, Senior Central Engineer, Novartis Consumer Health Inc, USA
    Lessons Learned About Risk Assessment and Critical Aspects
13:30 – 17:15 Flexible API Manufacturing

  • Leader: Sarah Mancini, Senior Mgr, API Tech Group, Pfizer, USA
  •  Frank Gupton, PhD, Technical Director, Virginia Commonwealth University, USA
    Streamlining Pharmaceutical Processes into Continuous Operations
  •  Patrick Kelleher, Sr Mgr-Team Leader Tech Lab, Pfizer, Ireland
    Flexible Scale Up in Pfizer One Approach Technology of the Future
  •  Michael O’Brien, Head Innovation-Tech Strategy, Pfizer Inc, USA
  •  Bernhardt Trout, Ph.D., Professor-Chemical Eng Dept, MIT, USA
    Transforming Pharmaceutical Manufacturing to Continuous
13:30 – 17:15 FOYA II

  • Leader: Kelly Keen, Senior Project Manager, Genentech Inc., USA
  •  Scott Billman, Director, Engineering, Novartis Vaccines & Diagnostics Inc., USA
    Advancing Vaccine Production for Pandemic Readiness
  •  Robert Dick, PE, Principal, Precis Engineering, Inc., USA
    Sustainability: Winning Commitment to Sustainable Design
  •  Sarah Fitzgerald, Associate Director, Global Eng Svcs, Merck, Ireland
    Operational Execellence: Building a Lean Structure for High Performance – Vaccine & Biologics Sterile Facility (VBSF)Carlow Ireland
  •  Philip Sass, Ph.D., Executive Vice President/COO, Morphotek Inc, USA
13:30 – 17:15 Data Integrity II: Cloud Controls

  • Leader: Kathleen Gniecko, IT Quality Management Services Head, Hoffmann-La Roche, Switzerland
    Cloud Computing in GxP Environment – The Promise and Road to Clarity
  • Leader: Michael Rutherford, Consultant, Lab Systems, Eli Lilly & Co, USA
  •  Monica Cahilly, President, Green Mountain Quality Assurance, LLC, USA
  •  Krishnakali Ghosh, CDER Compliance Officer, CDER/OC/OMPQ/DGMPA, USA
    Data Integrity in the Cloud – The Regulatory Perspective
  •  Robert Streit, Sr Mgr Quality & Compliance, Johnson & Johnson, USA
    Data Integrity in the Cloud: The Promise, Reality and Road to Clarity
  •  Anders Vidstrup, Senior IT Quality SME, NNIT A/S, Denmark
    Data Integrity in the Cloud: The Promise, Reality and Road to Quality
13:30 – 17:15 Master Planning Within the Pharmaceutical Industry

  • Leader: Dennis Romak, VP Food/Pharma Markets, Process Plus, USA
  •  Steven Duckro, Senior Engineering Manager, Aptalis Pharmatech, USA
    Utilization of a Master Plan: Perspectives from Management & Engineering
  •  Timothy Grinstead, Sr Director Mfg Ops-NA, Aptalis Pharma, USA
    Utilization of a Master Plan: Perspectives from Management & Engineering
  •  Kenneth Popham, Senior Architect, Process Plus, USA
    Master Planning Processes
  •  John Schlagetter, Senior Architect, ProcessPlus, USA
    Facility Master Planning – How To Look Forward
13:30 – 17:15 Quality Systems and the Cost of Non-Compliance

  • Leader: Rose Mary Dollard, Director, Johnson & Johnson, USA
  •  Eric Good, Vice President, Quality, KV Pharmaceutical, USA
    Quality Systems and the Cost of Non-Compliance
  •  Tara Gooen, LCDR, PHS, Branch Chief (acting), FDA/CDER/OMPQ, USA
  •  Lisa Ray, Advisor-DCOE Exter. Sourcing, Eli Lilly and Company, USA
    Third Party Organization Management and Oversight: Evolution Requires Focus
13:30 – 17:15 Advanced Aseptic Processing II

  • Leader: Joerg Zimmermann, Dir Process Dev Implementation, Vetter Pharma Fertigung GmbH Co KG, Germany
  •  Aarti Gidh, Investigator, GlaxoSmithKline, USA
    Product Impact study to Support Technology Transfer to a Commercial Isolator Enclosed Filling Line
  •  Aaron Mertens, US Technical Manager, Atec Pharmatechnik, USA
    Equipment Replacement with a Stopper Processing System
  •  James Thompson, Senior Engineer, Amgen Inc, USA
    Technology Transfer of a Viscous, High-Concentration Protein Product: Case study in Filling Pump Technology Selection
  •  Philipp Trojan, Mgr Compliance & CAPA, AbbVie GmbH & Co., Germany
    Applying Quality Risk Management into Aseptic Manufacturing
13:30 – 17:15 Latin America Regulatory Compliance Forum

  • Leader: Gregory Gallegos, Sr Program Dir, Tech Regulatory, Genentech, USA
  • Leader: Marta Vidal, Consultant, Angostura Salud, Argentina
  •  Stephen Colgan, Ph.D., Senior Director in Global CMC, Pfizer Global Research and Dev, USA
    Opportunities for Lean Stability Strategies
  •  Eugenia Gotsis, Assoc Director, Reg. Affairs, Abbott Pharmaceuticals, USA
    Import Testing Requirements and Opportunities for Waivers
  •  Rebecca Komas, Dir CMC Advocacy-Strategy, GlaxoSmithKline, USA
    Alternatives for Faster Approvals in Latin America
  •  Birgit Unterladstaetter, Global Quality Manager, F. Hoffmann La Roche Ltd, Switzerland
    Challenges and Opportunities with Multi-Product Facilities for High Potent Drugs
13:30 – 17:15 Breakthrough Therapy—Are You Ready for Approval?

  • Leader: Eric Thostesen, Sr Dir-Strategic Bus. Support, Janssen Pharmaceutical Company Inc., USA
  •  Tara Gooen, LCDR, PHS, Branch Chief (acting), FDA/CDER/OMPQ, USA
  •  John Groskoph, Sr Dir., New Products CMC, Pfizer, USA
    Risk Management Poitns to Consider CMC Planning for Small Molecule Product Launch Small Molecule
  •  Brian Kelley, VP Bioprocess Development, Genentech Inc, USA
    Risk Managment in CMC Planning for BT Applications Impact of Accelerated Launch in the Development Pathway, Large Molecule
  •  Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA, USA
  •  Christine Moore, Ph.D., Acting Office Director, FDA, USA
  •  Sarah Pope Miksinski, PhD, Director (Acting), FDA/ONDQA/DNDQA 2, USA
  •  Kelly Swinney, Associate Director, Vertex Pharmaceuticals, Inc., USA
13:30 – 17:15 Science-Engineering-Compliance: Essentials of GMP Manufacturing – A Young Professionals Track – Effective Project Leadership

  • Leader: Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA
  •  Kenneth Ewan, Principal, KME Leadership LLC, USA
    Effective Project Leadership – Are you managing or are you leading – Understanding the distinction
  •  Richard Gunderlock, Dir, Corp Validation Services, Astra Zeneca Global Ops Supply, USA
    Example of a worthy mission for a Biotech Project, The Merck-China hepatitis B Technology Transfer Project
  •  Jerald Polly, Principal, Flad Architects, USA
    Baxter Case Study
  •  Daniel Rouse, PE, Assoc. Director Project Eng, Novartis Vaccines & Diagnostics Inc, USA
13:30 – 17:15 Investigational Products – Defining the new Landscape of Clinical Supplies: Risk Management and the Supply Chain – Part II

  • Leader: Neal Gordon, Ph.D., Director, Project Management, Merck, USA
  • Leader: Lorann Morse, SVP, Clinigen CTS, Clinigen, USA
  •  Nicola Barnes, Director, Pfizer Ltd, United Kingdom
    An evolution – a patient and site focused approach to booklet label designs
  •  Robert Scarth, VP and General Manager, Clintrak Clinical Labeling Services, USA
    Clinical Labeling Technology and Innovation
  •  Paul Thomas, Chief Technical Officer, Clinigen Group, United Kingdom
    EU GDP – links to Clinical Trials
  •  Terrence Walsh, Head, Comparator Network, TransCelerate BioPharma Inc, USA
    TransCelerate Introduction and The Comparator Network
13:30 – 17:15 “Provide for and promote a Project’s General Welfare” – Managing Project Implementation to assure Quality throughout the Project Management Lifecycle

15:00 – 16:00 Networking Break in Exhibit Hall
19:00 – 22:00 Tuesday Party
Wednesday, 6 November
08:00 – 13:00 “Ensure the Blessings of Project Success” – Managing Project Closeout to Assure Quality throughout the Project Management Lifecycle

  • Leader: Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA
  • Leader: Jeffery Odum, CPIP, Director Ops, Biotech Lead, IPS, USA
08:00 – 13:00 Investigational Products – Defining the New Landscape of Clinical Supplies: Labeling and Industry Updates

  • Leader: Neal Gordon, Ph.D., Director, Project Management, Merck, USA
  • Leader: Lorann Morse, SVP, Clinigen CTS, Clinigen, USA
  •  Nicola Barnes, Director, Pfizer Ltd, United Kingdom
    Labeling Panel Discussion
  •  Timothy Brewer, President, Yourway Transport, USA
  •  Sandra Cook, PhD, President, Cook Consulting, USA
    The Blinding of Materials in Clinical Trials: Essential Processes for Ensuring the Integrity of Clinical Study Data
  •  Matthew Gilson, Director Computer Systems QA, GlaxoSmithKline, USA
  •  David Glynn, Sr Mgr New Prod. Planning, Sunovion Pharmaceuticals Inc, USA
    ISPE Update
  •  Robert Scarth, VP and General Manager, Clintrak Clinical Labeling Services, USA
    The Future of Clinical Labeling
08:00 – 13:00 Current Regulatory Issues: QbD, Q7

  • Leader: Tara Gooen, LCDR, PHS, Branch Chief (acting), FDA/CDER/OMPQ, USA
    Challenges to Inspection Readiness for QbD Applications
  • Leader: Roger Nosal, VP CGMC, Pfizer Inc, USA
    Industry Perspective of Evolution of Quality by Design In NCE Implementation
  •  Betsy Fritschel, Director Quality & Compliance, Johnson & Johnson, USA
    Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q&A Development & Status
  •  Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA, USA
    FDA Perspective of Improving Quality of Biopharmaceuticals
  •  Lynne Krummen, Vice President, Genentech Inc, USA
    Biotech Lessons Learned from the Genentech and Roche QbD Journey
  •  Christine Moore, Ph.D., Acting Office Director, FDA, USA
    ONDQA View on Implementation of QbD:  Successes and Remaining Challenges
  •  Alicia Mozzachio, RPh, MPH, Director Regulatory, FDA Interface Management Branch, USA
    ICH Q7:  Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q&A Development and Status
08:00 – 13:00 Integrating Risk Management as part of Process Development

  • Leader: Bikash Chatterjee, President & CTO, Pharmatech Associates, USA
    Integrating Risk Management as Part of Product, Process, and Quality System Development
  • Leader: Wai Wong, VP Gen. Mgr Worldwide Ops, Pharmatech Associates, Inc, USA
    Introduction: Integrating Risk Management as Part of Product, Process, and Quality System Development
  •  Brett Duersch, Associate Director, Chemistry, Merck & Co Inc, USA
    ICH Q9 Applied to Small Molecule Process Development, Scale-up and Implementation
  •  Ian Leader, PhD, Product Dev Director, Shire Pharmaceuticals, United Kingdom
    Practical Risk Assessment for Process Design in a Virtual Development Environment
  •  Vincent McCurdy, Ph.D., Head Operational Excellence, Pfizer Inc, USA
    Introduction to a Holistic Approach to Quality Risk Management of Product and Process Development
08:00 – 13:00 Stratefied Sampling Plans

  • Leader: Thomas Garcia, Research Fellow, Pfizer Inc, USA
    Introduction and the basis for the withdrawal of the draft guidance for industry “Powder Blends and Finished Dosage Units – Stratified In-Process Dosage
  •  James Bergum, President, BergumSTATS, LLC, USA
  •  Karthik Iyer, Senior Policy Analyst, FDA, USA
    Innovative Approaches to Assure Adequacy of Mixing
  •  James Prescott, Senior Consultant, Jenike & Johanson Inc, USA
    CU/BU Variations – How Far is Too Far? (By way of examples)
  •  Ravi Tejwani, Senior Principal Research Scientist, Bristol-Myers Squibb, USA
    Relating blend uniformity specification to finished product
  •  Alex Viehmann, Operations Research Analyst, FDA, USA
    FDA Recommendations Regarding In-process Sampling of Finished Dosage Units
  •  Huiquan Wu, CDER/OPS/OTR/DPQR, USA
    Recommended Innovative Approaches to Ensuring Adequacy of Mixing of Powder Blends
10:15 – 10:30 Networking Break
13:00 – 14:00 Lunch
13:00 – 18:00 Manufacturing Facility Tour
14:00 – 15:30 Global Regulatory Summit

  •  Richard Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA/CDER, USA, FDA/CDER, USA
  •  Tara Gooen, LCDR, PHS, Branch Chief (acting), FDA/CDER/OMPQ, USA
  •  Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA, USA
  •  Christine Moore, Ph.D., Acting Office Director, FDA, USA
  •  Ian Rees, Expert GMP Inspector, MHRA, United Kingdom
  •  Robert Sausville, Director, Division of Case Management, Office of Compliance and Biologics Quality, CBER, USA

 

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