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2020 PDA Pharmaceutical Manufacturing Data Science Workshop

Jul 23, 2020
Raleigh, NC

  • Conference
  • Workshop
  • The Americas

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Program Highlights


This one-day workshop will provide hands-on experience for managers in the pharmaceutical manufacturing field. Learn best practices for breaking down data silos using traditional and advanced analytics to realize the promise of “Pharma 4.0” so that you can evaluate project proposals, their results, and transfer to the business.

Get an interactive preview of the types of data science dashboards you'll develop during one of the many hands-on sessions during the Workshop.

Data Science Sample Report


  • Thursday, April 2

    7:15 a.m. – 5:00 p.m. | Registration Open

    7:15 a.m. – 8:15 a.m. | Continental Breakfast

    8:15 a.m. – 10:00 a.m. | P1

    In this opening session, participants will review the foundations of pharmaceutical manufacturing data science, including the industry 4.0 paradigm and the structure of a data science project. Principles for the day, vocabulary, and use cases will also be outlined. Then, participants will load the first use case and begin to assess the data quality.

    8:15 a.m. | Welcome and Opening Remarks from Workshop Chair
    Arne Zilian, PhD, Manufacturing Science and Technology, Global Head Systems and Standards, Novartis

    8:30 a.m. | Foundations of Pharmaceutical Manufacturing Data Science
    Arne Zilian, PhD, Manufacturing Science and Technology, Global Head Systems and Standards, Novartis

    9:00 a.m. | Case 1: Data Transformation: Breaking Down Silos
    Richard Love, Founder, HarborView LLC

    10:00 a.m. – 10:30 a.m. | Refreshment Break in Exhibit Area

    10:30 a.m. 12:00 p.m. | P2

    In the second plenary, participants will continue using the first use case to build a quality metrics dashboard for a product portfolio. Following this exercise, the predictive release concept will be introduced in preparation for the second use case.

    10:30 a.m. | Case 1: Quality Metrics Dashboard
    Richard Love, Founder, HarborView LLC

    11:30 a.m. | Predictive Release
    Toni Manzano, PhD, R&D Director and Founder, Bigfinite

    12:00 p.m. – 1:00 p.m. | Network Lunch

    1:00 p.m. 2:30 p.m. | P3

    Participants will take the second use case to build a predictive release model with the goal to improve the manufacturing processes through artificial intelligence (AI), glean knowledge from historical data, and apply knowledge in real-time. After the use case, the implementation roadmap will be analyzed to show how to start small to deliver results early and then how to extend the steps to work on more complex opportunities.

    1:00 p.m. | Case 2: Data Assessment
    Toni Manzano, PhD, R&D Director and Founder, Bigfinite

    2:00 p.m. | Build the Roadmap
    Vasu Rangadass, PhD, President and CEO, L7 Informatics

    2:30 p.m. – 3:00 p.m. | Refreshment Break in Exhibit Area

    3:00 p.m. 5:00 p.m. | P4

    In the final session, participants will review the agile ways of working and change management under GxP and then will finish their second use case checking the quality of the AI results. The workshop will end with feedback and shared learnings.

    3:00 p.m. | Agile Methodology and Testing Tools
    Frank Gorski, Director, Quality Assurance – Technology Audits, Merck

    3:30 p.m. | Case 2: Required Quality around AI
    Toni Manzano, PhD, R&D Director and Founder, Bigfinite

    4:30 p.m. | Feedback and Closing Remarks
    Arne Zilian, PhD, Manufacturing Science and Technology, Global Head Systems and Standards, Novartis

Highlighted Speakers

Frank L. Gorski
Frank L. Gorski
Merck & Co., Inc.
Richard N. Love
Richard N. Love
HarborView LLC
Toni Manzano
Toni Manzano
Vasu Rangadass
Vasu Rangadass
L7 Informatics, Inc.
Arne Zilian
Arne Zilian

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of this Workshop, you will be able to:

    • Recognize and discuss foundational data science concepts, workflows, methods, and vocabulary
    • Justify the need for multivariate statistics
    • Develop simple data science models for pharmaceutical manufacturing problems, and evaluate their quality
    • Compare and contrast the commonalities and differences between PAT and Predictive Release/ Digital Twin models
    • Give examples of the main use-cases in digital transformation, their prerequisites, and their benefits
    • Design a roadmap supporting digital transformation
    • Describe the benefits of agile ways-of-working and how they still satisfy all regulatory/GMP expectations
    • Summarize the principles supporting change control and maintenance of data science models
  • Who Should Attend

    Who Should Attend


    QA | Quality | Quality Metrics | Regulatory | Manufacturing Science and Technology | Technical Services | Operations | IT

    Level of Expertise

    Manager | Project Leader

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PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Raleigh Convention Center

500 South Salisbury Street
Raleigh, NC

Raleigh Convention Center

A block of rooms have been reserved for meeting participants in three hotels within walking distance of the Raleigh Convention Center. The correlating rates listed are for single or double occupancy per night. All guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, February 28, 2020. After this date, reservations can be made on a space-and-rate available basis only.


Marriott City Center

500 Fayetteville Street
Raleigh, NC 27601

Rate: $205/night

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Sheraton Raleigh

421 South Salisbury Street
Raleigh, NC 27601

Rate: $209/night

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Residence Inn Downtown Raleigh

616 South Salisbury Street
Raleigh, NC 27601

Rate: $213/night (Please note: this rate includes daily breakfast)

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How to Get Here

By Air

Raleigh-Durham International Airport (RDU) is 14.9 miles away. Airport Phone: +1 (919) 840-7700

By Car

GoTriangle's Route 100 ( bus picks up and drops off at the airport from Downtown Raleigh's GoRaleigh Station every 30 minutes through 6:30 PM and then hourly through the evening. The GoRaleigh Station is a convenient 3 1/2 blocks from the RCC.

Other Options

Estimated taxi fare: $45 (one way)

Car sharing services (ex: Uber) are available from the Raleigh airport, passengers are to meet car at the pickup section outside of the baggage claim.


Registration Fees

Regular Price
Registration Type  
Member $1,095
Non-member $1,095

* 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 Feb 28, 2020, no fee will be charged. After Feb 28, 2020, 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 Feb 28, 2020, a full refund will be given minus a $200 fee. After Feb 28, 2020, 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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Program Inquiries
  • Molly E. O’Neill, CMP
    Vice President
    Tel: +1 (301) 656-5900 ext. 132
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Registration Customer Care

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

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