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2019 PDA Building a Foundation and Culture for Quality Risk Management Integration Workshop

Dec 11, 2019
Washington, DC

Mastering Risk Management for Organizational Success

  • Workshop
  • 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 Building a Foundation and Culture for Quality Risk Management Integration Workshop will feature real-world case studies from organizations that have established QRM programs. You'll learn the steps for creating a strong quality culture as a prerequisite for a successful QRM program.

Register by October 25 and save up to $200! 
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 2019 PDA Building a Foundation and Culture for Quality Risk Management Integration Workshop is designed to enable attendees to actively participate in defining successful risk management applications that can be translated to the workplace.

Come prepared to roll up your sleeves and learn by doing in interactive sessions to help you better understand the importance of quality culture and its relationship to quality risk management.

Highlights of the interactive sessions include:

  • Breaking the Barriers to a Successful Risk Culture
    Address specific risk culture challenges in the “World Café Poster Session.” Spend designated time at a series of posters to identify management methods and approaches to tackle each risk culture challenge
  • Choose Your Own Adventure: Managing Risk Communication
    Benefit from lively dialogue and critical thinking as you break into small teams to unravel a case study where decisions must be made and communication must be clear.  Each team will share its journey and rationale for resolutions reached.



  • Wednesday, December 11

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

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

    8:00 a.m. – 9:30 a.m.
    P1: What is a Risk Culture and Why is it Important?
    Moderator: Steve R. Mendivil, BS, Independent Consultant

    Two perspectives on what is a Risk Culture is and Why It's Important. A Regulators view of how to assess a company’s Risk Culture and how is it being developed and sustained to prevent quality and drug shortage issues. A CEO perspective on assessing a variety of risks within a company. How does Quality Risk fits into the overall risk assessment and prioritizing resources? How important is it to build and maintain a Risk Culture in which risk can be identified within a company and its suppliers to be properly assessed and prioritized for proper mitigation? What are the Cultural Attributes that are needed to build a Risk Culture and prevent major issues leading to disasters?

    8:00 a.m. – 8:15 a.m.
    Welcome and Opening Remarks
    Anette Yan Marcussen, Partner, Compliance Consulting, NNE

    8:15 a.m. – 8:35 a.m.
    David M. Churchward, MSc, Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector, MHRA, UK

    8:35 a.m. – 8:55 a.m.
    Guy Villax, CEO, Hovione

    9:05 a.m. – 9:30 a.m.
    Questions and Answers/Discussion

    9:15 a.m. – 10:00 a.m.
    Exhibit Area Open

    9:30 a.m. – 10:00 a.m.
    Refreshment Break in Exhibit Area

    10:00 a.m. – 11:30 a.m.
    Workshop 1: Breaking the Barriers to a Successful Risk Culture
    Moderator: Sue J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    World Café Poster session, where facilitated groups will discuss and identify approaches to manage specific risk culture challenges.

    11:30 a.m. – 12:00 p.m.
    P2: Academia Influence of the QRM Culture
    Moderator: Ghada Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.

    In 2005, the Pharmaceutical Regulatory Science Team (PRST), a research team based at the Dublin Technological University (TU Dublin) in Ireland, was established in direct response to the drive for a paradigm shift in quality from the international regulatory community. The PRST research emphasis is on the development of patient-focused strategies to enable those involved in the manufacture of drug products meet the evolving international regulatory expectations. The PRST research model is based on proactive engagement with global industry and regulators in order to explore and address the challenges and opportunities of implementing science and risk-based manufacturing approaches. This session looks at examples of how TU Dublin is collaborating with the Biopharmaceutical Sector and Regulators to carry out Doctoral level research into the role of effective QRM and KM in Product Realization for the 21st Century.

    11:00 a.m. – 12:00 p.m.
    Anne Greene, Professor, Lecturer and Pharmaceutical Project Manager, TU Dublin, School of Chemical and Pharmaceutical Sciences

    12:00 p.m. – 1:00 p.m.

    1:00 p.m. – 1:30 p.m.
    Workshop 1: Report Out
    Moderator: Sue J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    Report out from Workshop 1 from each poster, highlighting top key challenges and remediations.

    1:30 p.m. – 2:45 p.m.
    Workshop 2: Choose Your Own Adventure: Managing Risk Communication
    Moderator: Lori Richter, Senior Consultant, ValSource, LLC

    Risk-based decision making can be demanding for leaders as they weigh both the benefits and challenges of taking risk in a regulated environment, where the patient is in the forefront of every decision. Communication is crucial to ensuring critical risk information is conveyed to the right people at the right time. In this session, participants will break out into teams at each table and work together to unravel a case study where decisions must be made, and communication must be clear. This workshop will be in the style of “choose your own adventure”, allowing teams to work through a case study and drive to various outcomes. Prepare for lively dialogue and critical thinking as your team traverses down the case study path and documents their rationale for the resolutions reached.

    2:45 p.m. – 3:15 p.m.
    Refreshment Break in Exhibit Area

    3:15 p.m. – 4:00 p.m.
    Workshop 2: Report Out
    Moderator: Lori Richter, Senior Consultant, Valsource

    In this facilitated report out, teams will discuss their decisions and communication pathways in their version of “choose your own adventure”.  The moderator will guide the discussion and ensure questions are answered and push the teams to provide robust rationale for their decisions. We will discuss the various outcomes of the scenario and how decisions may be different depending on the risk landscape.

    4:00 p.m. – 5:15 p.m.
    Workshop 3: Risk Register Infographic
    Moderator: Eva M. Urban,
    Director, Quality Risk Management, CSL Behring

    Teams will develop infographics on elements of a risk register and the infrastructure required for sustainment.

    4:00 p.m. – 4:15 p.m.
    Eva M. Urban, Director, Quality Risk Management, CSL Behring

    4:15 p.m. – 5:00 p.m.
    Group Poster
    Each team will build a poster to cover one of the following topics:

    • E2E QRM Program to manage product risk
    • The sources of risks to consider E2E for a fictional product risk register
    • The infrastructure and governance to sustain a risk register
    • Layout and design of a risk register template and process to maintain it through risk review
    • QRM Metrics developed from the risk register

    5:00 p.m. – 5:15 p.m.
    Closing Remarks and Adjournment
    Lori Richter, Senior Consultant, ValSource, LLC and
    Eva M. Urban, Associate Director GMP/GDP Compliance QRM, Celgene International Sarl

Additional Information

  • Learning Objectives

    Learning Objectives

    At the completion of the workshop, 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 $1,095
Non-member $1,295
Young Professional Member $548
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 $1,295
Non-member $1,495
Young Professional Member $648
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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