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2018 PDA Manufacturing Intelligence Workshop

Mar 21 - Mar 22, 2018
Orlando, FL

Digital Strategies to Drive Manufacturing and Supply Chain Reliability

  • Workshop
  • The Americas
Program Highlights

This inclusive event is designed to enable participants to discuss the needs and challenges of managing manufacturing-related data. Acquiring an understanding of the development and implementation of big data strategies will also be a key take away! Find out how the holistic use of data and corresponding insights gained can be an effective way to meet many of the challenges surrounding global manufacturing in a regulated bio/pharmaceutical industry.


Following the 2018 Annual Meeting in Orlando, Florida, the PDA is hosting, for the first time, the Manufacturing Intelligence Workshop. This Workshop will provide a venue for obtaining the latest information on the development of bio/pharmaceutical big data and insights at the shop floor. The forum is ideal for learning how the industry is developing its capacity to better use of data insights.

The committee’s goal is to design an inclusive event allowing Workshop attendees to learn and discuss the needs and challenges of managing manufacturing-related data.  Acquiring an understanding of the development and implementation of big data strategies will also be a key take away. The ultimate purpose of the Workshop is to encourage participants to recognize that the holistic use of data and corresponding insights gained is an effective way to meet many of the challenges of surrounding global manufacturing in a regulated bio/pharmaceutical industry.

Sessions will focus on:

  • Big data fundamentals
  • Real-world case studies
  • Manufacturing information models
  • Digital Quality management
  • Designing big data strategies
  • Top risks/challenges surrounding big data

Don’t miss out on this important learning opportunity. Make plans now to attend the 2018 PDA Manufacturing Intelligence Workshop.

Learning Objectives

At the completion of this event, attendees will be able to:

  • Assess an organization's analytical maturity level in terms of culture, internal process readiness, analytical capabilities, and data environment to facilitate implementation of big data strategies
  • Identify capabilities focused on improving operations through tighter integration, linking of physical and cyber capabilities, and taking advantage of information to provide end-to-end manufacturing intelligence
  • Analyze the current state of processes, forecast optimal progress, and proactively control them based on reliable predictions to enhance predictive control
  • Examine the potential impact of production-related quality and regulatory concerns as they relate to the use of big data in manufacturing and supply chain management
  • Describe innovative solutions to computer system validation to introduce advanced analyses in a fashion that is useful, effective, and compliant

Who Should Attend

Job Function:
Scientist, Engineer, Statistician | Executive and Mid-Level Management | Project Management | Technical Services | Supply Chain | Manufacturing Application | Risk Management

Manufacturing | Product Development | Quality | Research & Development | Regulatory Affairs | Engineering | Automation | Information Technology | Validation | Data Science | Statistics | Operational Excellence


Workshop Inquiries
Jason Brown

Assistant Director, Programs
(301) 656-5900 ext. 131
Email: [email protected]

Registration Inquiries
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
Email: [email protected]

Exhibition Inquiries
David Hall
Vice President, Sales 
Tel: +1 (240) 688- 4405
Email: [email protected]


  • Wednesday, March 21

    3:00 p.m. – 6:00 p.m.
    Registration Open

    4:15 p.m. - 4:30 p.m.
    Welcome and Opening Remarks from the Chairs of the 2018 Manufacturing Intelligence Workshop
    Michele D’Alessandro, Vice President and CIO, Manufacturing IT, Merck & Co., Inc.
    Aaron R. Goerke, PhD, Director, Head of MSAT, Singapore Technical Operations, F. Hoffmann-La Roche Ltd.

    4:30 p.m. – 6:00 p.m.
    P1: Leveraging the Power of Modern Data to Solve Problems and Improve Manufacturing
    Moderator: Aaron R. Goerke, PhD, Director, Head of MSAT, Singapore Technical Operations, F. Hoffmann-La Roche Ltd.

    Session Description: The manufacturing world is undergoing its fourth industrial revolution, spurred by the proliferation of digital capabilities and the integration of these capabilities into existing production and supply systems. The Pharmaceutical industry cannot ignore technology’s impact on the way manufacturers conduct business.  Because the information age has created these mountains of data, the aim of this session is to generate a common understanding of the fundamentals of big/modern data.  A “box of chocolate” summary of the collaborative efforts to transpire throughout the workshop will follow via Pecha Kucha format presentations, where we uncover the unexpected. A final session take away will be an example disruption in the way data is made available, processed, and ultimately used to drive outcomes in product development, quality control, process analytics, or beyond.

    4:30 p.m. – 4:50 p.m.
    Beyond the Buzz – What Big Data, Artificial Intelligence, and the Internet of Things Really Mean to Pharmaceutical Manufacturing
    Chris Garvin, Principal Engineer, Digital Integration and Predictive Technologies, Amgen, Inc.

    4:50 p.m. – 4:55 p.m. 
    Breakout Session 1 Preview
    Richard F. Shakour, Director, IT Account Management, Merck & Co., Inc.

    4:55 p.m. – 5:00 p.m.
    Session P4 Preview
    Mark DiMartino, Director, Quality Engineering, Amgen, Inc.

    5:00 p.m. – 5:20 p.m.
    Next Generation Manufacturing-A Step Towards Industry 4.0
    Rob Guenard, PhD, Senior Director, Global Manufacturing Sciences, Biogen

    5:20 p.m. – 6:00 p.m.
    Poster: Thursday Session Highlights

    7:00 p.m. – 10:00 p.m.
    Annual Meeting Closing Reception: A Night in Havana
    (Your full conference badge will be needed to access this reception)

    Thursday, March 22

    7:30 a.m. - 5:00 p.m.
    Registration Open

    7:30 a.m. - 8:30 a.m.
    Continental Breakfast

    8:30 a.m. - 9:15 a.m.
    P2: Key Note Session 1 
    Moderator: Emma Ramnarine, Head, Global Biologics Quality Control, Genentech, A Member of the Roche Group

    Session Description: Insights from outside of the pharmaceutical industry will be explored when going from traditional manufacturing to a fully digitized enterprise.  The journey has transformed nearly every part of the business, from supply chain and logistics, to factory planning and utilization, quality assurance and even research and development.   Discussion will occur surrounding the importance of moving past simple metrics and data analytics and how the true benefits come from combining pervasive digitization with proactive modeling and simulation.   Future directions for the digital enterprise will be highlighted and how these same principles might be effectively applied in the pharmaceutical industry.

    8:30 a.m. - 9:00 a.m.
    The Digital Enterprise Insights from Non-Pharma Branches
    Alastair Orchard,
    Vice President, Digital Enterprise, Siemens

    9:00 a.m. – 9:15 a.m.
    Questions and Answers/Discussion

    9:15 a.m. - 9:45 a.m.
    Refreshment Break

    9:45 a.m. - 12:00 p.m.
    Breakout Sessions

    A: Manufacturing Information Model: Key Enabler for Pharma Digital Transformation

    Arne Zilian, Head, MS&T Processes and Standards, Novartis Pharma AG

    Session Description: A recent big data PDA ideation session identified a cross-industry, standardized Manufacturing Information Model (MIM) as being a key enabler for a Pharmaceutical industry digital transformation.  This breakout session will first bring to you the voice of the customer and define the Pharmaceutical Manufacturing Information Model. It will also summarize preliminary studies, explore why a cross-industry MIM is important, identify what applications are available commercially and opportunities for their enhancement.  In an interactive session, we will look into MIM use cases offering most benefit, or deficiencies impairing benefit to be overcome. As a result of this workshop, we will have identified opportunities for PDA member companies and potential MIM collaborations.

    9:45 a.m. – 10:15 a.m.
    Introduction and Manufacturing Information Model Review

    10:15 a.m. – 10:35 a.m.
    Building the Use Cases-Interactive Discussion

    10:35 a.m. – 10:55 a.m.
    Identifying the Challenges-Interactive Discussion

    10:55 a.m. – 11:15 a.m.
    Potential Areas for Collaboration-Interactive Discussion

    11:15 a.m. – 11:45 a.m.
    Define Next Steps/Team Definition

    11:45 a.m. – 12:00 p.m.
    Closing Remarks/Questions

    B: Big Data Analytics – A Key Enabler for Process Robustness – Explore the Space where you Don’t Know what you Don’t Know

    Leo Xu, Director, GlaxoSmithKline

    Session Description: The goal of a manufacturing strategy is to consistently deliver high quality and affordable products to customers every time and all the time.  Excellence in manufacturing process robustness is an essential element of a successful manufacturing strategy.
    With ever increasing advances in the digital technology, large amounts of process data are available for analysis.  In addition to the traditionally monitored process parameters, many additional sources of data can be captured such as all other process parameters, time-based equipment performance parameters, raw material characterization data, and analytical testing results.  Application of advanced mathematical and statistical methodology will significantly enhance the ability to integrate and analyze manufacturing big data, improve fundamental process understanding, detect problem before it occurs, and ultimately achieve the goal of process robustness.
    In the workshop, we will work together to understand the challenges that our industry is facing in process robustness, share the best practice in data analytics, identify areas for process robustness improvement, explore the collaboration among the companies, and establish the milestones for deliverables. 

    9:45 a.m. – 10:05 a.m.

    10:05 a.m. – 10:30 a.m.
    Evolution of Large Molecule Process Monitoring Program
    Stephen Dorsch, Associate Director, Global Technical Operations, Merck & Co., Inc. 

    10:30 a.m. – 10:55 a.m.
    Case Study 2

    10:55 a.m. – 11:35 a.m.
    Roundtable Discussion

    11:35 a.m. – 11:45 a.m.
    Closing Remarks/Questions

    C:  Inexactitude vs. Precision – Designing and Implementing a Big Data Strategy in a Regulated Environment

    Richard F. Shakour, Director, IT Account Management, Merck & Co., Inc.

    Session Description: The emergence of the Internet has fundamentally transformed many industries; however, it is only since the rise of the Industry 4.0 concept that the digital revolution has reached the core of industrial manufacturing. The PDA Taskforce will consider the applicability of structured and unstructured manufacturing data/information (GxP vs non GxP) as it relates to the new paradigm

    9:45 a.m. – 10:00 a.m.

    10:00 a.m. – 10:20 a.m.
    Use Case 1 - Using Industry 4.0 Concepts to Improve Decision-Making by Machines and People
    Chris Garvin, 
    Principal Engineer, Digital Integration and Predictive Technologies, Amgen, Inc.

    10:20 a.m. - 10:30 a.m.
    Roundtable Discussion

    10:30 a.m. – 10:50 a.m.
    Use Case 2 - Enabling Comprehensive Data Analytics and Process Monitoring in Bio Manufacturing
    Robert Dimitri, Associate Director, Manufacturing Systems, Shire

    10:50 a.m. - 11:00 a.m.
    Roundtable Discussion

    11:00 a.m. – 11:20 a.m.
    Use Case 3 - Does the Data Lake have to be Validated?
    Sonia Banerjee, PMP, 
    Director, IT Architecture,Merck & Co., Inc.
    Dan Wasser,
    Associate Director, Process Intelligence and Technology, Bristol Myers Squibb

    11:20 a.m. - 11:30 a.m.
    Roundtable Discussion

    11:30 a.m. – 11:45 a.m.
    Closing Remarks/Questions

    12:00 p.m. - 1:00 p.m.

    1:00 p.m. – 1:45 p.m.
    P3: Key Note Session 2
    Moderator: John Moehnke, Project Manager, Engineering Software Solutions, LLC

    Session Description: Attendees will gain cross industry insights from Disney’s innovative decisions sciences team, focused on driving sustainable value capture.  It’s a great opportunity to gain an outside-in perspective on a digital journey applied in another industry, including lessons learned and critical success factors.

    1:00 p.m. – 1:30 p.m.
    Decision Science: Learnings from the Front Line
    Hai D. Chu, Vice President, The Walt Disney Company

    1:30 p.m. – 1:45 p.m.
    Questions and Answers/Discussion

    1:45 p.m. – 2:15 p.m.
    Refreshment Break in Exhibit Area

    2:15 p.m. - 3:45 p.m.
    P4: Opportunities and Risks with Modern Data Analysis Techniques in Regulated Pharmaceutical Manufacturing Environmentt

    Mark DiMartino, Director, Quality Engineering, Amgen, Inc.
    Brett Duersch, Director, Engineering, Merck & Company, Inc.

    Session Description: Advances in computing power and storage have not only resulted in the ability to collect and store vast amounts of data, it has also led to the development of powerful and innovative data analysis and computing methodologies to extract insights from the data and automate repetitive tasks. These methodologies include artificial intelligence applications such as machine learning, neural networks, natural language processing, and robotic process automation capabilities. The goal of this session is to discuss the application of these techniques in the quality and manufacturing environments, and to solicit ideas for topics that would benefit from joint discussion and collaboration across regulatory, industry and academic groups to improve the quality, cost and reliability for Pharmaceutical Manufacturing. After the workshop key topics will be presented to the PDA for creation of future PDA workstreams. After the workshop key topics will be presented to the PDA for creation of future PDA workstreams.

    3:45 p.m. - 4:00 p.m.
    Refreshment Break in Exhibit Area

    4:00 p.m. - 5:00 p.m.
    P5: Panel Discussion and Key Takeaways
    Moderator: Michele D’Alessandro, Vice President and CIO, Manufacturing IT, Merck & Co., Inc.

    Session Description: Panel discussion with industry experts on opportunities and challenges of digital strategies in Manufacturing.  Additionally, hear a synthesis of the 1.5-day PDA workshop on Manufacturing Intelligence.


    Hai D. Chu, Vice President, The Walt Disney Company
    Rob Guenard, Senior Director, Global Manufacturing Sciences, Biogen
    Alastair Orchard, Vice President, Digital Enterprise, Siemens
    Jack Prior, Head, Manufacturing Science, Global MSAT, Sanofi

    5:00 p.m.
    Thank You and Closing Remarks from the Co-Chairs of the 2018 Manufacturing Intelligence Workshop
    Michele D’Alessandro, Vice President and CIO, Manufacturing IT, Merck & Co., Inc.
    Aaron R. Goerke, PhD, Director, Head of MSAT in Singapore, F. Hoffmann-La Roche Ltd.

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation


    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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Registration Fees

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Regular Registration

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by , no fee will be charged. After , a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by , a full refund will be given minus a $200 fee. After , no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.


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