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2019Quality-1988x680

2019 PDA Optimizing Quality Risk Management Conference

Dec 12 - Dec 13, 2019
Washington, DC

Mastering Risk Management for Organizational Success

  • Conference
  • The Americas

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Program Highlights

U.S. FDA’s Janet Woodcock, MD, and Author Thomas Stanton to Headline 2019 PDA Quality Week

The 2019 PDA Optimizing Quality Risk Management Conference will explore ways to leverage risk-based approaches for the success of your organization. It will also cover how successfully applying risk-based approaches can optimize the overall life-cycle management of a product, as envisioned by ICH Q12 – QRM as a key enabler to change management.

Register for two events and save 10% or register for all three and save 15%!

Overview

The inaugural 2019 PDA Quality Week, Dec. 9-13 at the Capital Hilton in Washington, DC, presents not only one conference, but two conferences and a workshop.

The Week concludes Dec. 12-13 with the second Conference, Optimizing Quality Risk Management, which will highlight the challenges and opportunities an organization faces when designing and implementing a holistic QRM program.

Topics such as “Harnessing the Power of Quality Risk Management” will be addressed through a discussion with industry leaders and regulators on the importance of QRM and how an effective program can provide organizations with a way to understand and mitigate risks to patients. Real-life practical examples of how industry is applying QRM will be shared.

The topic of “Quality Risk Management as a Strategic Driver in the Organization” addresses designing and implementing a holistic QRM program and the challenges around it. Discussion will focus on how QRM is less of a toolset and more of a strategic capability.

In this session, attendees will engage with a panel of experts and hear directly from industry leaders on their companies’ QRM programs and underlying strategies. The interactive panel discussion will cover many aspects and challenges to developing, maintaining, and sponsoring QRM programs and capabilities.

"Deploying QRM” is another topic of this important second Conference of the Week. ICH Q9 and ICH Q10, Pharmaceutical Quality System, both reference where quality risk management principles should be applied in the Quality Management System. However, there is very little instruction and “how to” guidance in either of these documents, with respect to building processes for implementing the suggested approaches. Attendees will have the opportunity to discuss examples of QRM integration into the quality systems.

This Conference will conclude with a QRM compliance update in which leading regulators will provide their perspectives on the use of QRM and practical aspects of QRM.

Agenda

  • Day 1
  • Day 2
  • Thursday, December 12

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

    7:00 a.m. – 8:00 a.m.
    Continental Breakfast

    8:00 a.m. – 10:00 a.m.
    P1: Harnessing the Power of Quality Risk Management
    Moderator: Steven R. Mendivil, BS, Senior Advisor Quality, Amgen, Inc.

    Quality Risk Management affords Industry and regulators a way to clearly review a topic, issue or event and assess the risks to the product and patient.  Successful use of QRM can provide us with a way to understand and mitigate these risks. In this session you will learn about real life practical examples of how industry is applying QRM.  We hope this session will inspire companies to continue to reassess and continually improve their QRM programs through a birds-eye view of how other companies are tackling implementation.

    8:00 a.m. – 8:15 a.m.
    Welcome and Opening Remarks
    Harold S. Baseman, MBA, Chief Operating Officer, ValSource LLC 
    Jason M. Urban, PhD, CA-AM, Head of External Engagement Global Quality, Bristol-Myers Squibb

    8:15 a.m. – 9:00 a.m.
    Opportunities to Harness the Power of Quality Risk Management
    Anil Sawant, MSc, PhD, 
    Senior Vice President, Global Quality Compliance, Merck & Co., Inc.

    9:00 a.m. – 9:45 a.m.
    Supply Chain Risk Quality Risk Management: Real Life Examples and Risk-Based Approaches
    Rebecca E. Dombrowski, MS, 
    Senior Policy Advisor, CDER, U.S. FDA

    9:45 a.m. – 10:00 a.m.
    Q&A Panel

    10:00 a.m. – 10:30 a.m.
    Refreshment Break and Poster Presentations

    Poster Presentations

    The following posters will be presented during refreshment breaks and the networking reception

    1. Create and Use a Custom Risk Management Tool
    Randy Friedman,
    Principal Quality Risk Management Specialist, Genentech, Inc.

    2. The Vision of QRM into QMS
    (Quality Risk Management into Quality Management System)
    Sofia van Berlekom, MSc,
    Global Quality Director, Corporate Quality & Strategy AstraZeneca


    10:30 a.m. – 12:00 p.m.
    P2: Quality Risk Management as a Strategic Driver in the Organization
    Moderators:
    Eva M. Urban, MSc, Director Quality Risk Management, CSL Behring

    Designing and implementing a holistic QRM program can be quite challenging. One of the biggest challenges can be moving the organization from viewing QRM as a toolset and shifting gears into seeing QRM as a strategic capability. There is no one size-fits-all approach to building these capabilities within the organization. However, there is no dispute that the benefit of using risk-based approaches in industry and health agencies, according to well-defined ISO, ICH and similar principles is a critical element to ensuring the ongoing safety of the patient.

    In this session you will hear from Industry leaders on their company’s QRM program and underlying strategies. This session will open with brief overview of each company’s QRM program followed by an interactive panel discussion covering many aspects and challenges to standing up and maintaining QRM programs and capabilities. Panel discussion will cover topics such as how QRM program leaders deal with challenges; what metrics are used to measure the success of QRM and how QRM is used for risk based scientific decision making, ultimately linking to ensuring the safety to the patient.

    10:30 a.m. – 10:45 a.m.
    QRM at AstraZeneca Operations: A Journey
    Sofia von Berlekom, MSc,
    Global Quality Director, Corporate Quality & Strategy, AstraZeneca

    10:45 a.m. – 11:00 a.m.
    Raising the Bar - Embedding Quality Risk Management Processes across the GxP Continuum
    Jason M. Urban, PhD, CA-AM,
    Head of External Engagement Global Quality, Bristol-Myers Squibb

    11:00 a.m. – 11:15 a.m.
    Implementing a QRM Program
    Heather A. Crews, BS,
     Associate Director, Quality Risk Management, Merck & Co., Inc.

    11:15 a.m. – 11:30 a.m.
    QRM Integration in Novo Nordisk A/S
    Michael Shousboue, MSc Pharm,
    Principal Specialist, Quality Risk Management, Novo Nordisk A/S

    11:30 a.m. – 12:00 p.m.
    Panel Discussion

    12:00 p.m. – 1:00 p.m.
    Networking Lunch

    1:00 p.m. – 2:30 p.m.
    P3: Deploying QRM – Part 1
    Moderator: Steve Mendivil, BS, 
    Senior Advisor Quality, Amgen, Inc.

    Understanding the principles of quality risk management is important but there are many other factors to successful deploying QRM into an organization’s quality management system. This session will explore the many challenges that await for those brave enough drive the implementation of an impactful quality risk management program across a site or across a global organization.

    1:00 p.m. – 1:30 p.m.
    The Pendulum Swings Both Ways: QRM Deployment That Aligns with Your Quality Culture
    Amanda M. McFarland, MS,
     Senior Consultant, ValSource, LLC

    1:30 p.m. – 2:00 p.m.
    Beyond the Regulations: The ANSI Standard Process
    Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc. 

    2:00 p.m. – 2:30 p.m.
    Q&A Panel

    2:30 p.m. – 3:00 p.m.
    Refreshment Break and Poster Presentations

    3:00 p.m. – 4:30 p.m.
    P4: Deploying QRM – Part 2
    Moderator: Lori Richter, 
    Senior Consultant, ValSource LLC

    ICH Q9 Quality Risk Management Process and ICH Q10 Pharmaceutical Quality System both reference where quality risk management principles should be applied in the Quality Management System. However, there is very little instruction and “how to” guidance in either of these documents, with respect to building processes for implementing the suggested approaches. This session will explore in detail how to implement two different QRM methodologies. One approach will be looking at using QRM tools in the management of excipients and the other will be in the management of equipment throughout its lifecycle. Participants will hear case studies and walk away with tips for implementation of both of these approaches.

    3:00 p.m. – 3:30 p.m.
    IPEC-PDA Tech Report 54-6 Risk Assessment for Excipients: Case Study: End-to-End “Risk Assessment and It’s Challenges”
    Eva M. Urban MSc, Director Quality risk Management, CSL Behring

    3:30 p.m. – 4:00 p.m.
    PDA Tech Report 54-5: QRM for Manufacturing Systems: QRM as a Source Knowledge
    Kelly Waldron, PhD
    , Senior Consultant, ValSource, LLC

    4:00 p.m. – 4:30 p.m.
    Q&A Panel

    4:30 p.m. – 5:30 p.m.
    Networking Reception

  • Friday, December 13

    7:00 a.m. – 11:45 a.m.
    Registration Open

    7:00 a.m. – 8:00 a.m.
    Continental Breakfast

    8:00 a.m. – 9:30 a.m.
    P5: QRM Application in Cell and Gene Therapy and Biologics – From Organization to Execution
    Moderator: Jason M. Urban, PhD, CA-AM,
     Head of External Engagement Global Quality, Bristol-Myers Squibb

    A one-size fits all approach to application of quality risk management can be limiting and lead to operational inefficiencies and ineffectiveness down the road. Taking this into account and compounding it with the latest revolution in medicine manufacturing we need to look at ways to adapt current tools to “fit for purpose”, as well as, take a deeper look at the organization and its readiness to move in the direction of an adaptable QRM program.

    This session will provide valuable information on the application of risk management tools across the lifecycle of cell therapy production, as well as, insights and approaches to assessing the maturity level of QRM at pharmaceutical facilities and organizations.

    8:00 a.m. – 8:30 a.m.
    How Different Quality Risk Management Tools Can Be Used During the Lifecycle of an ATMP Product
    Monica Hueg MSSc, Managing Consultant, NNE 

    8:30 a.m. – 9:00 a.m.
    QRM Maturity Assessment – The Great Ally
    Tais H. Conti, MA,
    Quality Systems and Compliance Senior Manager, Bristol-Myers Squibb

    9:00 a.m. – 9:30 a.m.
    Q&A Panel

    9:30 a.m. – 10:00 a.m.
    Refreshment Break

    10:00 a.m. – 11:45 a.m.
    P6: Fideside Chat with Regulators and Industry Experts
    Moderator: Ghada N. Haddad, PhD, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.
    Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc.

    Leading regulators and industry representatives give their perspective on the use of and practical aspects of quality risk management.

    10:00 a.m. – 10:30 a.m.
    State of QRM Implementation: Current Challenges and Successes
    Rick L. Friedman, 
    Deputy Director, Science and Policy, OMPQ, CDER, U.S. FDA

    10:30 a.m. – 11:30 a.m.
    Panel Discussion
    Michael Blackton, Vice President, Addaptimmune LLC,
    Mary Farbman, PhD, Executive Director, Compliance Remediation and Support, Merck & Co., Inc.
    Rick L. Friedman, Deputy Director, Science and Policy, OMPQ, CDER, U.S. FDA
    Andrew D. Hopkins, BSc, Hon PGDIP, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.
    Lori Richter, Senior Consultant, ValSource, LLC

    11:30 a.m. – 11:45 a.m.
    Closing Remarks and Adjournment
    Ghada N. Haddad, PhD, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.
    Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc.

Highlighted Speakers

Rick L. Friedman
Rick L. Friedman
FDA
Monica  Hueg
Monica Hueg
NNE
Amanda M. McFarland
Amanda M. McFarland
ValSource LLC
Anil Sawant
Anil Sawant
Merck & Co., Inc.
Michael Schousboe
Michael Schousboe
Novo Nordisk A/S
Sofia van Berlekom
Sofia van Berlekom
AstraZeneca
Kelly Waldron
Kelly Waldron
Valsource LLC

Additional Information

  • Learning Objectives

    Learning Objectives

    At the completion of the conference, attendees will be able to:

    • Understand the value and role of quality risk management: regulatory and industry perspectives
    • Practical implementation and sustainment of a QRM program
    • Role of senior management in sponsoring a quality culture
    • An overview of the PIC/S Expert Circle on QRM
    • A QRM approach to designing a more efficient and effective pharmaceutical quality system
  • Who Should Attend

    Who Should Attend

    Job Functions

    Executive and Mid-Level Management | Manufacturing Application | Project Management | Risk Management | Scientist | Supply Chain | Technical Services

    Departments

    Engineering | Information Technology | Laboratory Science | Manufacturing | Product Development | Quality Risk Management | Quality Systems | Regulatory Affairs | Research & Development | Sterile Processing | Supply Chain Management | Technology Transfer | Training | Vaccines | Validation
  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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Travel

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.

Capital Hilton

1001 16th Street NW
Washington, DC
Phone: +1 (202)-393-1000

Capital Hilton
  • Accommodations

    The cut-off date has now past, however rooms may still be available at the Capital Hilton on a space-and-rate available basis only. Guestroom rates are subject to State and Local taxes. Check-in time is 4:00 p.m.; check-out time is 11:00 a.m.

    To make reservations, call the Capital Hilton at +1 (202) 393-1000. Please note that a first night's deposit, refundable up to 3 days in advance of arrival for cancellations, will be charged when making reservations.

    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 3 days in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

    Combining style, historical character, and an enviable location, Capital Hilton is the place to stay when visiting Washington DC. We're located just blocks from the capital's best attractions including The White House, the National Mall and a multitude of museums. With comfortable rooms and suites, a great restaurant, and extensive event space, the hotel offers all you need for an unforgettable trip to DC.

    Read more about the amenities offered at the Capital Hilton.

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 5 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 25 miles away, and Baltimore-Washington International Airport (BWI), 30 miles away.

Taxi fares from DCA are approximately $20 one way, not including tip, and will take about 30 minutes. One way taxi fares from IAD is approximately $55 and from BWI about $85.

By Car

Captial Hilton is located at 1001 16th Street NW, Washington, DC 20036.

$62 (per day) Valet Parking. Self Parking is not available at the Capital Hilton

Other Options

More information coming soon.

Directions

Registration Fees

Early Registration
Registration Type Price by Nov 15
Conference
Member $1,495
Non-member $1,695
Young Professional Member $748
Gov’t/Health Auth. Member $700
Gov’t/Health Auth. Non-member* $800
Academic Member $700
Academic Non-member* $800
Student Member $280
Student Non-member* $310


Regular Registration
Registration Type Price after Nov 15
Conference
Member $1,695
Non-member $1,895
Young Professional Member $848
Gov’t/Health Auth. Member $700
Gov’t/Health Auth. Non-member* $800
Academic Member $700
Academic Non-member* $800
Student Member $280
Student Non-member* $310


* 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 30 days before the event, no fee will be charged. After this period, 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 30 days before the event, a full refund will be given minus a $200 fee. After this period, 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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