New This Year! Compelling Keynote Presentations Spanning the Product Lifecycle

Education to Move Your Company Forward

Explore, strategize, develop tools, and determine how to navigate organizational and regulatory complexities to advance patient therapies.

"Exciting conference with plenty to learn from all different facets of the industry!"
          ~2016 ISPE Annual Meeting & Expo Attendee

                                                                                                    "Engagement opportunities were numerous and the social events facilitate these interactions."     
                                                                                                                          ~2016 ISPE Annual Meeting & Expo Attendee

"ISPE is a great meeting. I usually go as an exhibitor but would also like the opportunity to attend educational sessions."
           ~2016 ISPE Annual Meeting & Expo Attendee

 

Education Details by Track          Expand all

End to End Supply Chain Management Track

Track Director: Niranjan Kulkarni, PhD, Operations Specialist, CRB
Co-Director: Neal Gordon, Director, Director MRL Logistics, Global Clinical Supplies, Merck, Sharp & Dohme Corporation

From clinical trials to commercialization – Managing supply chains through innovative solutions and technology 

Artificial Intelligence: Taking the Mystery Out of Supply Chain Planning
Sunday, 29 October 13:00 - 14:00

  • Leader: Dennis Stamm, Partner, Dir. Industrial Engineering Services, InnovaNet Group, USA
  • Michael Cobb, PhD, President, The InnovaNet Group, USA
  • Tariq Ismail, PhD, President, The Minestream, LLC, USA

Connecting the Supply Chain Dots: Sales, Inventory, Order, Make, Deliver
Monday, 30 October 11:00 - 12:30

  • Leader: Nicholas Davies, M.Sc. B.Sc., Managing Partner, Co-Chair Operations, Management COP, Verta Life Sciences, USA
  • Robert DiVasto, PE, Zavante Therapeutics Inc, USA
  • Michael Kays, EVP Supply Chain, Avara Pharmaceutical Services, USA
  • Stephanie Roede, President, Life Science IT, Inc., USA

Advances in Deterministic Parenteral Container Closure Integrity
Monday, 30 October 11:00 - 12:30

  • Leader: Oliver Stauffer, CEO-VP Inspection Technologies, PTI Inspection Systems, USA

Innovation & Technology in the Clinical Supply Chain
Monday, 30 October 13:45 - 15:15

  • Leader: Neal Gordon, PhD, Director, MRL Logistics, Global Clinical Supplies, Merck, USA
  • Leader: Greg Hottell, Director, Clinical Interface Group Lead, GlaxoSmithKline, USA

The PRA-Takeda Strategic Partnership: Is it the Wave of the Future?
Monday, 30 October 16:15 - 17:45

  • Leader: Julie Jacobs, PRA Health Sciences, USA
  • Beth Gardner, Senior Director, Clinical Supply Strategy, Takeda Pharma America Inc, USA
  • Jodi Luce, Executive Director, Merck & Co Inc, USA

Serialization: Holistic Approaches, Current, & Predicted Trends
Monday, 30 October 16:15 - 17:45

  • Leader: Alfred Penfold, Senior Project Manager, PM Group, United Kingdom
  • Padraic Duffy, Project Manager, Hyde Engineering + Consulting Europe Ltd, Ireland

Innovative Techniques to Improve Supply Chain Flexibility and Responsiveness
Tuesday, 31 October 10:45 - 12:15


Direct to Patient: Strategies, Processes, and Lessons Learned
Tuesday, 31 October 16:00 - 17:15

  • Leader: Catherine Hall, MS, MBA, Associate Director of Clinical Trial Material Management, Sunovion Pharmaceuticals, USA
  • Neal Gordon, PhD, Director, MRL Logistics, Global Clinical Supplies, Merck, USA
  • Michael Sweeney, Senior Director, Global Service Development, World Courier Management Inc. - New Hyde Park, NY, USA

Leverage Expiry Date Material Planning to Reduce Waste
Tuesday, 31 October 16:45 - 17:15

  • Leader: Randa Atiyeh, Associate Director, Project Management (Clinical Supplies), Merck & Co Inc, USA

Quality & Compliance Considerations for Shipping Temperature Controlled Investigational Products
Wednesday, 1 November 08:30 - 09:30

  • Leader: Michael Sweeney, Senior Director, Global Service Development, World Courier Management Inc. - New Hyde Park, NY, USA
  • Greg Hottell, Director, Clinical Interface Group Lead, GlaxoSmithKline, USA

Future Utilization of MedLabel for Clinical Trials
Wednesday, 1 November 09:45 - 10:45



Facilities and Equipment Track

Track Director: Michelle M. Gonzalez, Engineering Director (Retired) AMGEN, Inc., BioPharm Engineering Consultant
Co-Director: Steven Wisniewski, Principal Compliance Consultant, Commissioning Agents, Inc. 

Meeting unique requirements for the facility design and production

WORKSHOP: Asset Management Triggers to Promote Design for Reliability (DfR)
Sunday, 29 October 13:00 - 15:15

  • Leader: Marie Getsug, PMP, CMRP, CPIP, CRL, Program Manager, Asset Management Consultancy, Jacobs Engineering Group, Inc. - Building & Infrastructure (B&I) Consultancy, USA
  • George Williams, Director of Asset Management, B. Braun Medical, USA

Using Advanced Modeling & Simulation to Improve Efficiencies in Animal Research Lab and Facilities
Sunday, 29 October 13:00 - 14:00

  • Leader: Niranjan Kulkarni, PhD, Director, Operations Improvement, CRB, USA
  • Kevin Chriswell, Senior Project / Lab Planner, CRB, USA
  • Alex Munoz, Senior Lab Planner, CRB, USA

Using The Revised ISPE Baseline Guide for Sterile Manufacturing Facilities
Monday, 30 October 11:00 - 12:30


Managing Risk in a Live Facility Renovation
Monday, 30 October 11:00 - 12:30

  • Leader: Evan Steinberger, Senior Architect - Facility Design Manager, Jacobs Engineering Group Inc, USA
  • Michael Canary, Head of Stregic Project Management, Siemens Healthcare, USA
  • Dennis Lucey, Senior Associate, PMA Consultants, USA

Facility of the Year Project Presentations I
Monday, 30 October 11:00 - 12:30


Pharmaceutical Water and Energy Savings: Green for Your Wallet and the Environment
Monday, 30 October 11:00 - 12:30

  • Leader: Brian Severson, Consultant, Critical Utilities Consultant, USA
  • Nissan Cohen, Principal Scientist- High Purity Water Systems, Commissioning Agents, Inc., USA
  • Norman Goldschmidt, Senior Principal, Vice President, Genesis Engineers Inc, USA
  • Nikola Krpan, President, Cheme Engineering Inc., Canada
  • Shlomo Sackstein, CEO, Biopuremax Ltd, Israel
  • Anders Widov, Owner / Consultant, Wiphe AB, Sweden

Amgen Singapore Next Generation Manufacturing
Monday, 30 October 13:45 - 15:15

  • Leader: Robert Bader, Sr Mgr Technology Pharma Bio, Jacobs Engineering Group Inc, USA
  • Robert Forbes, RA, Architectural Design Manager, Jacobs, USA
  • Michael Greening, Director Engineering, Amgen Inc, Singapore

Integrated Project Delivery
Monday, 30 October 13:45 - 15:15

  • Leader: Curt Biehn, Design Manager, Jacobs Engineering Group Inc, USA
  • Andrew Dell, MS Engineering, Engineering Director, Merck & Co Inc, USA
  • Michael Sullivan, Director, SBB Daldrop, LLC, USA

Facility of the Year Project Presentations II
Monday, 30 October 13:45 - 15:15


Genentech Oceanside: A Flexible CHO Manufacturing Facility
Monday, 30 October 13:45 - 15:15

  • Leader: Eric Fallon, PhD, Senior Director, Head of Global Biologics Manufacturing Sciences and Technology, Genentech Inc, USA
  • Elizabeth Danbe, Senior Engineer, Genentech, USA
  • Christian Kaempfen, Project Director, Genentech Inc, USA

Compliant and Sustainable Facilities - The Future of Pharma
Monday, 30 October 13:45 - 15:15

  • Leader: Gregory Bujewski, Principal Mechanical Engineer, Giliad Sciences, Inc., USA
  • Keith Beattie, Head of Life Sciences Division, Energy Efficiency Consultancy Ltd, United Kingdom
  • David Estape, PhD, Technology Manager Life Sciences, M+W Central Europe GmbH, Germany
  • Norman Goldschmidt, Senior Principal, Vice President, Genesis Engineers Inc, USA

Application of the NEW ISPE OSD Baseline Guide - Third Edition: Understanding the Architectural, HVAC and Risk Management Considerations for OSD Facilities of the Future
Monday, 30 October 16:15 - 17:45

  • Leader: Dave DiProspero, Director of Pharmaceutical Process Technology, CRB, USA
  • Jack Chu, PE, Vice President, Life Sciences, RPA Engineering, USA
  • Norman Goldschmidt, Senior Principal, Vice President, Genesis Engineers Inc, USA
  • Tim Mallo, Director, Merck & Co Inc, USA
  • Robert Matje, CPIP, PE, Principal, RemTech, LLC, USA
  • George Ruiz, BEChe, OSD Project Technical Manager, AstraZeneca, USA
  • Michael Wilson, Associate, Architect, CRB, USA

Project Delivery – Impact of Project Driver and Regional Conditions
Monday, 30 October 16:15 - 17:45

  • Leader: Drew Johnston, Pharma Eng'g, Venture Management, Americas, Bayer, USA
  • Todd Dando, West Coast General Manager - Life Sciences & Advanced Manufacturing, Fluor Daniel, USA
  • Robert Forbes, RA, Architectural Design Manager, Jacobs, USA

Increasing Operational Efficiency in Existing Facilities
Monday, 30 October 16:15 - 17:45

  • Leader: Michael Byron, Senior Project Manager, Seiberling Associates Inc, USA
  • Scott Klemme, Process Engineer, Genentech Inc, USA
  • Steve Welsch, Project Manager, Seiberling Associates Inc, USA

Lab/Office/WH Project Delivery - Methods and Practices
Tuesday, 31 October 10:45 - 12:15

  • Leader: Eric Hanson, Director, Biologics Support Operations, Gilead Sciences, Inc., USA
  • Mark Davis, Principal, DGA planning|architecture|interiors, USA
  • Brad Kraus, Project Manager, DPR Construction, USA
  • Jeff Wegner, CRB - Carlsbad, CA, USA

The First 100 Days of a Capital Expansion Project
Tuesday, 31 October 10:45 - 12:15

  • Leader: William Deckert, Senior Consultant, Commissioning Agents, Inc., USA
  • Robert Chew, PE, President/CEO, Commissioning Agents, Inc., USA
  • Roger Filannino, Project Manager, CAI, USA
  • John Ward, Vice President, Patheon - Framingham, USA

A New Biomanufacturing Paradigm: Off-the-Shelf Facility
Tuesday, 31 October 10:45 - 12:15

  • Leader: David Estape, PhD, Technology Manager Life Sciences, M+W Central Europe GmbH, Germany
  • Firman Ghouze, Director Commercial Strategy, GE Healthcare Life Sciences,
  • Raco Ivan Jordanov, Co-Founder, President and CEO, JHL (Wuhan) Biotech Co., Ltd., Taiwan
  • Johan Rosenquist, Senior Director Global Operations, GE Healthcare Bio-Sciences AB, Sweden

“Don’t Let it Out!” A Practical Approach to Containment in Sterile Manufacturing Facilities
Tuesday, 31 October 10:45 - 12:15

Sponsored by Women in Pharma

  • Leader: Jason Collins, AIA, Dir. Process Architecture, IPS, USA
  • Vincent Cebular, MBA, BS. Chem. E., Senior Vice President, Compliance Services, IPS, USA
  • Christa Myers, Senior Pharmaceutical Engineering Specialist, CRB, USA

How to Execute the World Largest Biotech Project
Tuesday, 31 October 16:00 - 17:15

  • Leader: Carsten Petersen, Director, NNE Pharmaplan, USA
  • Gary Lohr, Director, Production Support, Novo Nordisk Pharma Industries Inc, USA

Surplus Equipment Disposition: Managing Surplus Assets
Tuesday, 31 October 16:00 - 16:30

  • Leader: Wayne Poole, Eli Lilly & Co., USA

Oligonucleotide Synthesis Manufacturing Facility Solution
Tuesday, 31 October 16:45 - 17:15


WORKSHOP: Risk, Reliability, Performance, Compliance and ASTM E2500
Wednesday, 1 November 08:30 - 10:45

  • Leader: Robert Chew, PE, President/CEO, Commissioning Agents, Inc., USA
  • Gert Moelgaard, Senior Consultant, Moelgaard Consulting, Denmark

Adaptive Mobile BioPharma Production Suite: Case Study
Wednesday, 1 November 08:30 - 10:45

  • Donald Masters, PhD, President and CEO, Artificial Cell Technologies, Inc., USA

Pharmaceutical Water Sampling
Wednesday, 1 November 09:45 - 10:45

  • Leader: Brian Hagopian, CPIP, Chemist and President, Clear Water Consulting, Inc., USA


Information Systems Track

Track Director: Eric Staib, Executive Director, Quality Assurance, PRA Health Sciences
Co-Director: Sam Brooks, Principal Consultant, Brooks Information Integrity Innovations 

Driving innovation with integrity in life-science information/GAMP®

WORKSHOP: Aligning System Validation and Data Lifecycles
Sunday, 29 October 13:00 - 15:15

  • Leader: Heather Longden, Sr Mktg Mgr, Info-Regulatory Compliance, Waters, USA
  • Leader: Charlie Wakeham, Regional Informatics CSV Consultant, Waters Corporation, Australia
  • Karen Ashworth, Director, Karen Ashworth Consulting Ltd, United Kingdom
  • Robert McDowall, PhD, Director, R D McDowall Ltd, United Kingdom
  • Garrett Mullen, Informatics Product Marketing Manager, Waters Corporation,
  • Arthur Perez, PhD, Retired, Novartis Pharmaceuticals, USA

Current Perspectives on Data Integrity
Monday, 30 October 11:00 - 12:30

  • Leader: Michael Rutherford, Consultant - Laboratory and Quality Systems, Eli Lilly and Company, USA
  • Monica Cahilly, President, Green Mountain Quality Assurance, LLC, USA
  • Robert Tollefsen, National Expert Investigator- Drugs/Computers, Medical Products and Tobacco Program Operations Branch, ORA/OO/OMPTO, USA, Invited

Practical Approaches to Data Integrity
Monday, 30 October 13:45 - 15:15


The ART of Efficient and Effective Computer Systems Validation
Monday, 30 October 13:45 - 15:15

  • Leader: Eric Staib, Executive Director of Quality Assurance, PRA Health Sciences, USA

Validation of Computerized eClinical Systems and Data
Monday, 30 October 16:15 - 17:45

  • Leader: Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
  • Leader: Eric Staib, Executive Director of Quality Assurance, PRA Health Sciences, USA
  • Frank Henrichmann, Director Technology Quality Management, PAREXEL International, Germany
  • Philip Räth, PhD, Vice President, Palleos Healthcare GmbH, Germany

Data Integrity Concepts – A Broader Approach
Tuesday, 31 October 10:45 - 12:15

  • Leader: Christopher White, Associate Director, IT Quality, Alexion Pharmaceuticals, USA
  • Lisa Ackerson, Vice President, Marketing, ByteGrid, USA
  • Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
  • Rebecca Santorios, Director of Compliance, ByteGrid, USA
  • Maximilian Stroebe, PhD, Electronic Systems QA, Astellas, Netherlands
  • Kip Wolf, Senior Managing Consultant, Tunnell Consulting, USA

Using SPC to Meet Product Quality Requirements
Tuesday, 31 October 16:00 - 16:30

  • Leader: Corey Vodvarka, Director of Manufacturing Solutions, Parsec Automation Corp., USA

Paperless Manufacturing
Tuesday, 31 October 16:00 - 16:30

  • Leader: Pamela Docherty, Life Sciences Industry Manager, Siemens Industry, Inc, USA
  • Todd Lybrook, PMP, US Director, Siemens, USA

Asset Information Lifecycle Modelling
Tuesday, 31 October 16:45 - 17:15

  • Leader: Jeremy Freeman, Associate Director/Sector Business Development Director, PM Group, Ireland
  • Colum Lynch, Information Management Strategist, PM Group, Ireland

Cloud Concepts - Cyber Security and Block Chain
Wednesday, 1 November 08:30 - 10:45

  • Leader: Stephen Ferrell, CISA, CRISC, Sr. Quality Director, IT Systems Compliance, Thermo Fisher Scientific, USA
  • James Canterbury, Senior Manager, Ernst & Young LLP, USA
  • Steven Thompson, ValGenesis, Inc., USA


Innovation Forum

Track Director: Michael O'Brien, PhD, Vice President Technology & Innovation, Pfizer Inc.
Regulatory Track Director: Sau (Larry) Lee, PhD, Associate Director for Science, FDA/CDER/OPQ
Co-Director: Anne Kantardjieff, PhD, Director, Early Stage Process Development, Biologics Process Development, Alexion Pharmaceuticals 

Navigating the current landscape of pharmaceutical research, development and manufacturing for successful innovation

Featured Session: Application of 3D Printing Technology in Dosage Form Design and Drug Delivery
Sunday, 29 October 14:15 - 15:15

  • Leader: Xiaoling Li, PhD, Professor - Associate Dean, University of the Pacific, USA
  • Senping Cheng, Founder and CEO, Triastek,
  • Jaedeok Yoo, PhD, Advanced Automation Researcher, GlaxoSmithKline, USA

Global Regulatory and Industry Environments
Monday, 30 October 11:00 - 12:30

  • Leader: Rajesh Beri, Head - Mammalian Manufacturing Research & Technology, Lonza Biologics Inc, USA

Emerging Methods, Equipment, and Technologies
Monday, 30 October 13:45 - 15:15

  • Leader: Stephen Hammond, Senior Director, Process Analytical Sciences Group, Pfizer Inc, USA
  • Jeffrey Weber, Sr PAT Project Manager, Pfizer Corp, USA

The Combination Development Process
Monday, 30 October 16:15 - 17:45

  • Leader: Susan Neadle, FAAO, FBCLA, Sr. Director, QE & DtV; Head, Combination Products CoE, Janssen Pharmaceuticals, USA

Innovative Trends and Applications in PAT
Tuesday, 31 October 10:45 - 12:15

  • Leader: Patrick Gammell, Director Process Development, Amgen Inc, USA
  • Stefan Buziol, PhD, Group Leader Process Development Fermentation, Roche Diagnostics GmbH, Germany
  • Pedro Felizardo, Chief Technology Officer, 4TUNE Engineering Ltd, Portugal
  • José Menezes, PhD, CEO, 4TUNE Engineering Ltd, Portugal

Innovative, Cross-Industry Strategic Partnerships
Tuesday, 31 October 16:00 - 17:15

  • Leader: Dennis Powers, Director of Sales Engineering, G-CON Manufacturing Inc., USA
  • Myung Kim, Associate Vice President, CannonDesign, USA
  • Erik Terry, Assoc VP Science & Technology, CannonDesign, USA

WORKSHOP: Emerging Therapeutic Modalities & Medical Devices
Wednesday, 1 November 08:30 - 10:45

  • Leader: Richard Denk, Head Sales Containment, SKAN AG, Switzerland
  • Robert Bayer, Director ADC Process Development and Tech Transfer, Ajinomoto Althea, USA


Product Development and Production Systems Track

Track Director: Steven R. Miller, Director, AstraZeneca
Co-Director: Robert Perks, Vice President, Operations, Werum IT Solutions 

Developing agile and flexible production systems for the next decade

WORKSHOP: Maximizing Manufacturing Utilization through Facility Design
Sunday, 29 October 13:00 - 15:15

  • Leader: Jeffery Odum, CPIP, SME, Global Technology Partner, Strategic Mfg, NNE, USA

Agility in Biotechnology Process Development
Monday, 30 October 11:00 - 12:30

  • Leader: Avril Vermunt, Bioprocess Hardware Applications, GE Healthcare Life Sciences, USA
  • Dana Becker, PhD, Principal Engineer, Amgen Inc, USA

Process Capabilities for Pharmaceutical and Biotech Industry
Monday, 30 October 13:45 - 15:15

  • Leader: Philippe Cini, PhD, Group Vice President, Tunnell Consulting, Inc., USA
  • Aaron Goerke, PhD, Head of Global Engagement & Deployment, Genentech, A Member of the Roche Group, USA
  • Stephan Krause, PhD, Director of QA Technology , MedImmune/AstraZeneca Supply Biologics, USA

Responding to Revolution - Transformative Thinking for Cellular-Based Therapeutics
Monday, 30 October 16:15 - 17:45

  • Leader: James Gazvoda, Principal, Flad Architects, USA
  • Christopher Brown, Manager, Therapeutic Cell Production Core and Process Development Groups, Seattle Children's Research Institute, USA
  • Derek Hei, Vice President of Clinical Manufacture, Quality, and Regulatory, Fujifilm Cellular Dynamics, Inc., USA
  • Geoffrey Quinn, Director, Engineering and Capital Projects, Juno Therapeutics Inc, USA

Facility Design Using Standardized Single Use Assemblies
Monday, 30 October 16:15 - 17:45


Engineering and Design for Continuous Manufacturing: Lessons Learned from the Users
Tuesday, 31 October 10:45 - 12:15

  • Leader: Stephen Sirabian, MBA, E.V.P., Glatt Air Techniques Inc, USA
  • Lawrence De Belder, Senior Principal Engineer, Johnson & Johnson, Belgium
  • Andreas Gottschalk, Glatt GmbH, Germany
  • Fernando Muzzio, PhD, Professor, Rutgers University, USA
  • Lilia Sprich, Director, New Technology Developement, Glatt GmbH, Germany

Implementing the Production Control Strategy
Tuesday, 31 October 10:45 - 12:15

  • Leader: Line Lundsberg-Nielsen, PhD, Global Technology Partner, NNE, United Kingdom
  • Leader: Christian Woelbeling, Senior Director Global Accounts, Werum IT Solutions GmbH, Germany
  • Lorenz Binggeli, QM-IT, B. Braun Medical AG, Switzerland

Continuous Bioprocessing: Current and Future State
Tuesday, 31 October 16:00 - 17:15

  • Leader: Marc Bisschops, PhD, Principal Scientist, Biopharm, Pall Life Sciences, Netherlands

Enabling Manufacturing Control Strategy
Tuesday, 31 October 16:00 - 17:15

  • Leader: Robert Perks, MSc CEng, Vice President, Operations, Werum IT Solutions, USA
  • Lisa Graham, PhD, Alkemy Innovation, USA

Manufacturing Enterprise Facility Design
Tuesday, 31 October 16:00 - 16:30

  • Leader: Jeffery Odum, CPIP, SME, Global Technology Partner, Strategic Mfg, NNE, USA

The Manufacturability Concept of a Commercial Product
Tuesday, 31 October 16:45 - 17:15

  • Leader: José Menezes, PhD, CEO, 4TUNE Engineering Ltd, Portugal
  • Ulrike Strauss, PhD, Manager DSP, Roche Diagnostics GmbH, Germany

Challenges of Combination Products
Wednesday, 1 November 08:30 - 09:30

  • Leader: Jorge Basso, VP, Product & Process Development, Pharmatech Associates Inc. - JUPITER, FL, USA
  • Mihaela Simianu, PhD, Director Regulatory Compliance, Pharmatech Associates, Inc., USA

Lessons Learned from Implementing BPOG's Risk Based Deviation Management
Wednesday, 1 November 09:45 - 10:45

  • Leader: Shawn Carner, Operational Excellence Lead - Drug Substance, Genentech, A Member of the Roche Group, USA


Quality Systems and Regulatory Track

Track Director: Christine Moore, PhD, Global Head & Executive Director, GRACS CMC-Regulatory Policy & Compendial Affairs, Merck, Sharp & Dohme Corporation
Regulatory Track Director: Robert Iser, Director (Acting), Office of Process & Facilities, FDA/CDER/OPQ/OPF
Co-Director: Frank Montgomery, PhD, Global Head, Regulatory CMC, AstraZeneca 

Balancing regulatory opportunities and quality challenges

Featured Session- ICH Q12: Fostering Change and Innovation
Sunday, 29 October 13:00 - 14:00

  • Frank Montgomery, PhD, Global Head, Regulatory CMC, AstraZeneca, United Kingdom
  • Mihaela Simianu, PhD, Director Regulatory Compliance, Pharmatech Associates, Inc., USA

Enabling Knowledge Excellence: Delivering Quality Innovation
Sunday, 29 October 14:15 - 15:15

  • Leader: Paige Kane, CPIP, Regulatory Science Resercher, Dublin Institute of Technology, USA
  • Nuala Calnan, PhD, Regulatory Science Adjunct Research Fellow, Dublin Institute of Technology, Ireland
  • Martin Lipa, Executive Director, MMD Knowledge Management, Merck, USA

Future State: Globally Harmonized Process Validation
Monday, 30 October 11:00 - 12:30

  • Leader: Matthew McMenamin, Manager, Systems & Technology, GlaxoSmithKline, USA
  • Leader: Jennifer Walsh, Director Robustness & Validation, Bristol-Myers Squibb, USA
  • Andrew Chang, PhD, Vice President, Quality and Regulatory Compliance, Product Supply Quality, Novo Nordisk A/S, USA
  • Tara Scherder, Partner, SynoloStats, USA

Quality Systems Integration for Acquisitions/Mergers and Suppliers
Monday, 30 October 13:45 - 15:15

  • Leader: Greg Anthos, Senior Managing Consultant, Tunnell Consulting, USA
  • Fredrik Asell, Head of QA, Supply Americas, AstraZeneca, USA
  • Stephanie Gaulding, Principal Consultant, DPS Engineering, USA
  • José Menezes, PhD, CEO, 4TUNE Engineering Ltd, Portugal
  • Olaf Sichler, Merck KGaA, Germany

Measuring and Managing Quality from an Overall System Perspective
Monday, 30 October 16:15 - 17:45

  • Leader: Thomas Friedli, PhD, Director of Institute of Technology Management, University of St. Gallen (Switzerland), Switzerland
  • Prabir Basu, PhD, President, Consultant, USA
  • Nuala Calnan, PhD, Regulatory Science Adjunct Research Fellow, Dublin Institute of Technology, Ireland

Changes in Regulatory Landscape: Regulator Updates
Tuesday, 31 October 10:45 - 12:15

This session will provide updates from regulators across the globe regarding changes in how their agencies approach regulatory review and inspections. Areas anticipated to be covered include the recent FDA reorganization of ORA and changes in Australia and Brazil in regulatory approaches for post approval changes. Audience questions are encouraged.

  • Leader: Christine Moore, PhD, Global Head and Executive Director, Merck & Co., USA

Global Regulatory Town Hall - General Session for All Attendees
Tuesday, 31 October 13:30 - 15:15


Drug Shortages: A Focused Review
Tuesday, 31 October 16:00 - 17:15

  • Leader: Diane Hustead, Associate Director, Regulatory Affairs, Merck & Co Inc, USA

Clinically Relevant Specifications for Drug Substance and Drug Product Impurities: The Why and How
Tuesday, 31 October 16:00 - 17:15


WORKSHOP: Creating a Strong Quality Culture: A Stepwise Interactive Process
Wednesday, 1 November 08:30 - 10:45

  • Leader: Norman Howe, PhD, Senior Partner, Validation & Compliance Institute, USA

Quality Management Systems Considerations for Implementation of Continuous Manufacturing
Wednesday, 1 November 08:30 - 09:30

Implementation of continuous manufacturing for solid oral dosage forms requires some special cGMP considerations. For example, it is important that the definition of "batch" be consistent with its use in the continuous manufacturing operation and how do we execute the process validation. An additional consideration includes the ability to track and respond to deviations in real time, including managing the segregation of potentially non-conforming material due to disturbances or upsets. This session will provide an overview of the considerations for quality management systems to support continuous manufacturing, both from an industry and regulator's perspective.

  • Leader: Yanxi Cain, PhD, Executive Director, Global Quality Assurance, Merck, USA
  • Arwa ElHagrasy, PhD, Acting Quality Assessment Lead, FDA/OPF/CDER, USA


Professional Development Sessions

Career Strategies for Early Career Professionals - Sponsored by Women in Pharma
Sunday 29 October 13.00 - 14.00
Leader: Kerren Bergman, Sr. Director, Human Resources, Hyde Enginerring
Kelly Keen, Project Portfolio Management, BPm, F Hoffman-La Roche
Kelly Scalva, Proposal Manager, Hyde Engineering

From College to the Real World: Biotech Facility Design
Sunday 29 October 14.15 - 15.15
Leader: Alan Bream, Process Engineer, CRB
Kevin Ventura, Process Engineer, CRB
Bryan Raborn, Process Engineer, CRB

Strategies for Seasoned Professionals - Sponsored by Women in Pharma
Sunday 29 October 14.15 - 15.15
Leader: Fran Zipp, President and CEO, Lachman Consultant Services

The Most Important Role of a Project Sponsor is...
Monday 30 October 11.00 - 12.30
Leader: James McGlade, Science Client Leader, BHDP Architecture
William Hill, Senior Program Manager, West Pharmaceutical Services
Kenneth Ewan, Principal, KME Leadership LLC
Patricia Melton, Managing Director, Mime Solutions Ltd.


2017 ISPE Annual Meeting & Expo Daily Schedule

Saturday, 28 October 2017

08.00 – 17.00 Committee Meetings
17.30 – 19.00 Leadership Reception (Invitation Only)

Sunday, 29 October 2017

07.30 – 15.30 Exhibitor Move-In
08.00 – 15.30 Committee Meetings
11.00 – 12.45 Young Professionals Brunch & Orientation
13.00 – 15.15 Education Sessions
15.15 - 15.30 Networking Break
15.30 – 17.00 Opening Keynote Session
17.00 – 18.30 Exhibit Hall Open
17.00 – 18.30 Welcome Reception

Monday 30 October 2017

06.30 – 08.00 5K Charity Run/Walk
07.15 – 08.15 New Member Breakfast
08.30 – 10.00 Keynote Session
10.00 – 17.00 Committee Meetings
10.00 – 16.15 Exhibit Hall Open
10.00 – 11.00 Networking Break
11.00 – 12.30 Education Sessions
12.30 – 13.45 Lunch
13.45 – 15.15 Education Sessions
15.15 – 16.15 Networking Break
16.15 – 17.45 Education Sessions
18.00 Open Night for Sponsored Events and Exploring the City

Tuesday 31 October 2017

08.00 – 10.00 Membership Breakfast & Awards
10.00 – 15.45 Committee Meetings
10.00 – 16.00 Exhibit Hall Open
10.00 – 10.45 Networking Break
10.45 – 12.15 Education Sessions
12.15 – 13.30 Lunch
13.30 – 15.15 Global Regulatory Town Hall
15.15 – 16.00 Networking Break
16.00 – 18.00 Exhibitor Move-Out
16.00 – 17.15 Education Sessions
19.00 – 22.00 Tuesday Night Party

Wednesday 01 November 2017

08.00 – 16.00 Committee Meetings
08.30 – 10.45 Education Sessions
11.00– 18.00 Facility Tours