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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 by October 25 and save up to $600!
Register for two events and save 10% or register for all three and save 15%!

Stay Informed to get the updates on speakers, session details, exhibitor information, courses, and more!


The third event taking place during Quality Week focuses on the challenges and opportunities an organization faces when designing and implementing a holistic QRM program.

A highlight of this Conference will be the dynamic Compliance Update session where regulatory and industry experts will discuss regulatory trends and answer your pressing questions.

Don't miss the mix of plenary sessions, poster presentations, and exciting question and answer sessions with the foremost industry experts in the worlds of risk management and regulatory issues.


  • 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: Janeen A. Skutnik-Wilkinson, Associate Director, Quality Intelligence, Biogen

    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, Chief Operations Officer, ValSource, LLC and
    Jason M. Urban, Executive Director External Engagement & Regulatory Intelligence, Bristol-Myers Squibb

    8:15 a.m. – 9:00 a.m.
    Anil Sawant, MSc, PhD, Senior Vice President, Global Quality Compliance, Merck & Co., Inc.

    9:00 a.m. – 9:45 a.m.
    Regulatory Representative Invited

    9:45 a.m. – 10:00 a.m.
    Questions and Answers/Discussion

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

    10:30 a.m. – 12:00 p.m.
    P2: Quality Risk Management as a Strategic Driver in the Organization (al Design)
    Eva M. Urban, MSc, Director, Quality Risk Management, CSL Behring, and 
    Jason M. Urban,
     Executive Director External Engagement & Regulatory Intelligence, Bristol-Myers Squibb

    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. – 10:40 a.m.
    RJ Doornbos, Head of Global Quality Systems, Bristol-Myers Squibb Company

    10:40 a.m. – 10:50 a.m.
    Stacey D. Largent, MEng, Director, QRM CoE, Merck & Co., Inc.

    10:50 a.m. – 11:00 a.m.
    Bill Mestrandrea, MBA, Senior Director GMP/GDP Compliance, Celgene

    11:00 a.m. – 11:10 a.m.
    Michael Shousboue, MSc Pharm, Principal Specialist, Quality Risk Management, Novo Nordisk

    11:10 a.m. – 11:20 a.m.
    Sofia von Berlekom, MSc Global Quality Director, Corporate Qualaity & Strategy, AstraZeneca

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

    12:00 p.m. – 1:00 p.m.

    1:00 p.m. – 2:30 p.m.
    P3: Deploying QRM – Part 1
    Moderator: Steve Mendivil, 
    Independent Consultant

    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 explores 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. Bishop McFarland, MS,
     Senior Consultant, ValSource, LLC

    1:30 p.m. – 2:00 p.m.
    Sue J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. and 
    Janeen A. Skutnik-Wilkinson, Associate Director, Quality Intelligence, Biogen

    2:00 p.m. – 2:30 p.m.
    Questions and Answers/Discussion

    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, Associate Director GMP/GDP Compliance QRM, Celgene International Sarl

    3:30 p.m. – 4:00 p.m.
    Kelly Waldron, Senior Consultant, ValSource, LLC

    4:00 p.m. – 4:30 p.m.
    Questions and Answers/Discussion

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

  • Friday, December 13

    7:00 a.m. – 12:00 p.m.
    Registration Open

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

    8:00 a.m. – 9:30 a.m.
    P5: Executing QRM in Advanced Cell & Gene Therapy (in Europe: ATMPs) Biologics
    Moderator: Jason M. Urban,
    Executive Director External Engagement & Regulatory Intelligence, Bristol-Myers Squibb

    8:00 a.m. – 8:30 a.m.
    Executing QRM in Advanced Cell & Gene Therapy, ATMPS, Biologics
    Monica Hueg MSSc, Managing Consultant, NNE 

    8:30 a.m. – 9:00 a.m.
    Tais Conti, Quality and Compliance Department Manager, Bristol-Myers Squibb Company

    9:00 a.m. – 9:30 a.m.
    Questions and Answers/ Discussion

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

    10:00 a.m. – 11:45 a.m.
    P6: Compliance Update on QRM
    Moderator: Ghada N. Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.

    Leading regulators give their perspective on the use of QRM by the regulators. Followed by an opportunity to ask questions about QRM with a panel discussion.

    10:00 a.m. – 10:30 a.m.
    Regulatory Representative Invited

    11:00 a.m. – 11:30 a.m.
    Panel Discussion
    Harold S. Baseman, MBA, Chief Operating Officer, ValSource, LLC
    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 Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc., and
    Sue J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

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


    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


    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: Knowledge

    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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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

Make a Reservation
Capital Hilton
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Capital Hilton. The rate is $209 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, November 1, 2019. 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 Capital Hilton at +1 (202) 393-1000. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. 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 (IAD), 25 miles away, and Baltimore-Washington International (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 Dulles 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.


Registration Fees

Early Registration
Registration Type Price by Oct 25
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 Oct 25
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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