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2018 PDA Manufacturing Intelligence Workshop

Digital Strategies to Drive Manufacturing and Supply Chain Reliability
Mar 21 - Mar 22, 2018 |
Mar 22, 2018 |
Loews Sapphire Falls | Orlando, FL
  • Workshop
  • Western Hemisphere Events
Exhibition: March 21-22
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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

Registration Inquiries
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115

Exhibition Inquiries
David Hall
Vice President, Sales 
Tel: +1 (240) 688- 4405

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.

Conference and Workshop Registration* | March 19-22


By January 8, 2018

After January 8, 2018


By January 8, 2018

After January 8, 2018

* Complimentary Conference registration does not qualify for discount offered for Workshop.

Workshop Registration | March 21-22

Wednesday/Thursday Only

PDA Member


All prices in US dollars.

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

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund, and photo release policies for this workshop and course.

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

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by January 18, 2018 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference, Workshops and Events: If your written request in received on or before January 18, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA Conferences.

Loews Sapphire Falls

Loews Sapphire Falls
6601 Adventure Way
Orlando, FL USA 32819
Tel: +1 (407)-503-5000

Reservation Group Call-In Center
Toll Free: +1 (866)-360-7395
Local: +1 (407)-503-9276

Please Note: Once your room confirmation number is received, a deposit of one night's room and tax will be taken from the credit card on your reservation. This deposit is refundable if a cancellation is made five days prior to arrival.

Rate: Single/Double: $252.00 - Guestroom rates are subject to State and Local taxes, 6% per room night occupied.

Cut Off Date: The cut off date has now passed. Please contact the hotel directly to secure a room based on availability.

Hotel Accommodations

A block of rooms have been reserved for meeting participants at the Loews Sapphire Falls. The rate is $252 for single or double occupancy. Please note that over 90% of the Sapphire Falls guestrooms are double queen rooms. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, February 16, 2018. After this date, reservations can be made on a space-and rate-available basis only. Check-in time is 4:00 p.m.; check-out time is 11:00 a.m.

To make reservations, individuals may click on the reservation link above or call the Loews Sapphire Falls at +1 (866)-360-7395. Please make sure to tell the reservationist that you are with the PDA group attending the 2018 PDA Annual Meeting to receive the PDA group rate.

Individual Cancellation

Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 72 hours prior to check-in to avoid cancellation fees.


Loews Sapphire Falls is conveniently located near Universal Orlando™. The venue features a beautifully landscaped, resort-style pool with a water slide surrounded by cascading waterfalls, this hotel truly captivates at every turn. From the ruins of the stone turret in the lobby, to the inviting island charm of the 1,000 guest rooms and suites, guests will be surrounded by a vivid, textured haven that is inspired by landmarks of the islands. The venue also offers a complimentary water taxi to the Universal CityWalk™ area, allowing guest to enjoy a variety of great restaurants and attractions.

Click here for additional information on service and amenities offered at Loews Sapphire Falls.


Orlando International Airport- (MCO) is located 18 miles (about 20-25 minutes) northeast from Loews Sapphire Falls.

Ground Transportation

Preferred Vendor

Destination MCO has been selected as the preferred vendor for airport transportation for Loews Hotels at Universal Orlando™. Exclusive chauffeured services begin at $115 (tax and gratuity included) for a sedan and can be charged to your geust room. Reservations are required. Visit or call the concierge at +1 (407)-503-5200.

Shared-Ride and Direct Service Airport Shuttles - Special Discount for PDA Attendees

Mears Transportation offers a shared-ride airport shuttle from Orlando International Airport to Loews Sapphire Falls. Tickets are available at the Mears Transportation counters located inside the baggage claim area on level two, as well as on level one where the shuttle departs for Loews Sapphire Falls Resort every 30 – 40 minutes. Reservations are not required. Pricing is shown below.

  • One-way fare: $21 adult or $16 child (ages 3-9)
  • Round-trip fare: $33 adult or $25 child (ages 3-9)

Mears Transportation also offers a direct service airport shuttle from Loews Sapphire Falls to Orlando International Airport. Travel time is approximately one hour. Reservations are required. Visit or call the concierge at 407.503.5200 at least 24 hours prior to departure.


Taxis are on standby at Orlando International Airport, offering service to and from Loews Sapphire Falls for an approximate fare of $55 each way, depending on traffic conditions. Standard taxis can accommodate up to four people. Travel time is approximately 30 minutes.


From Orlando International Airport
Take the north exit onto the Martin B. Andersen Beachline Expressway (State Road 528) West approximately 11 miles to Interstate 4 (I-4) East. Continue on I-4 East to exit 75A (Universal) and turn left onto Universal Boulevard. Continue on Universal Boulevard to Hollywood Way and turn left. Continue on Hollywood Way and turn left onto Adventure Way. Loews Sapphire Falls is on the left at 6601 Adventure Way.
Note: FL-528 is a toll road with one toll of $2.25 between Orlando International Airport and Loews Sapphire Falls.

From Florida's Turnpike
Take exit 259 (Orlando) onto I-4 West. Travel on I-4 West to exit 74B (Universal) and continue on Adventure Way. Loews Sapphire Falls Resort is the first entrance on the right at 6601 Adventure Way.

From Eastbound Interstate 4
Take exit 75A and continue to Universal Boulevard. Turn left onto Universal Boulevard and travel approximately one-half mile to Hollywood Way. Turn left onto Hollywood Way. Continue on Hollywood Way and turn left onto Adventure Way. Loews Sapphire Falls Resort is on the left at 6601 Adventure Way.

From Westbound Interstate 4
Take exit 74B (Universal) and continue on Adventure Way. Loews Sapphire Falls Resort is the first entrance on the right at 6601 Adventure Way.

From Southbound Interstate 95
Take exit 205 (State Road 528). Travel on FL-528 to I-4 East. Travel on I-4 East to exit 75A and continue to Universal Boulevard. Turn left onto Universal Boulevard and travel approximately one-half mile to Hollywood Way. Turn left onto Hollywood Way. Continue on Hollywood Way and turn left onto Adventure Way. Loews Sapphire Falls Resort is on the left at 6601 Adventure Way.

From Northbound Interstate 95
Take exit 260B (I-4 West). Travel on I-4 West to exit 74B (Universal) and continue on
Adventure Way. Loews Sapphire Falls Resort is the first entrance on the right at 6601
Adventure Way

Hotel Parking

Self-parking at the Loews Sapphire Falls is $22 overnight or $24 daily. Valet parking is $29 overnight or $34 daily.

Sponsorship and Exhibit Opportunities are Available!

The 2018 PDA Manufacturing Workshop offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. This workshop will bring together industry experts from Manufacturing, Product Development, Quality, Research and Development, Automation, Regulatory Affairs, Engineering, Data Science, Statistics, and Validation.

At this Workshop you will be exposed to high quality attendees from a variety of manufacturing companies – making this a must attend meeting. In addition, high profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, refreshment breaks, lunch and networking reception. We’ll create a customized sponsorship to fit your needs and budget.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall, Vice President, Sales

Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296


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