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.
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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13:30 – 17:15 |
“Provide for and promote a Project’s General Welfare” – Managing Project Implementation to assure Quality throughout the Project Management Lifecycle
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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
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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
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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
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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
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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
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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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