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2019Quality-1988x680

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 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.

At the Workshop, Building a Foundation and Culture for Quality Risk Management Integration, attendees will be able to actively participate in defining successful quality risk management applications that they can then implement in their workplace. They will engage with regulators to understand how they assess a company's Risk Culture and how organizations should go about developing and sustaining a risk culture to prevent quality and drug shortage issues.

Questions such as, How does Quality Risk fit into the overall risk assessment and prioritizing of 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?, and What are the Cultural Attributes that are needed to build a risk culture and prevent major issues leading to disasters? will be discussed.

As the Workshop is intended to be interactive and offer participants an opportunity to strategize on how they might help their organizations implement a total risk management program, three Workshop breakout sessions are included as part of the program.

Workshop 1 will engage participants in identifying ways for breaking the barriers to a successful risk culture and finding approaches to managing specific risk culture challenges. Topics such as the value proposition for implementing a QRM program and senior leaders’ influencing of risk culture will be on the table for discussion.

Workshop 1 will also address how academia has influenced the QRM culture. Professor Anne Greene from TU Dublin will speak about how the Pharmaceutical Regulatory Science Team (PRST) responded to the drive for a paradigm shift in quality from the international regulatory community and how the work of PRST researchers 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.

In Workshop 2, Lori Richter will lead a session on managing risk communication within an organization. The working session will explore how risk-based decision making can be demanding for leaders as they weigh both the benefits and challenges of taking risks in a regulated environment, where the patient is at the forefront of every decision and the importance of communication in ensuring critical risk information is conveyed to the right people at the right time. In this session, participants will break out into teams and work together to unravel a case study where decisions must be made, and communication must be clear.

Workshop 3’s theme is Risk Register Infographics. In this workshop, the attendees will have the opportunity to build posters to covers topics such as End-to-End QRM Program to manage product risks, the sources of risks to consider for a fictional product risk register, the infrastructure and governance to sustain a risk register, and more.

To conclude the day, attendees will present their posters at the cocktail hour, while enjoying finger food and drinks.

Although the Workshop is designed to be a standalone mini-conference, attendees are encouraged to participate in the full week program, depending on where they are at in implementing QRM in their companies.

Agenda

  • 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, Senior Advisor Quality Amgen, Inc.

    This session will feature two perspectives on risk culture and its importance. First, a regulator’s 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. This presentation will be followed by a CEO’s perspective on assessing a variety of risks within a company. How does quality risk fit 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, MPharm, Managing Consultant, NNE A/S

    8:15 a.m. – 9:00 a.m.
    Organizational Culture as a QRM Enabler: A Regulatory View
    David M. Churchward, MSc, Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector, MHRA, UK and
    Guy Villax, CEO, Hovione

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

    9:15 a.m. – 3:15 p.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: Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc.

    What are the characteristics of an effective risk-based management culture? How do you determine if you have an effective risk-based culture? This session will involve audience participation in trying to identify what attributes and behaviors need to be present in the company culture in order to implement an effective QRM program. Participants will provide input on a number of topics related to the cultural characteristics needed for a functioning quality risk management system as well as discussing potential obstacles that prevent companies from achieving a sustainable QRM program. Ideas on how to overcome some of the perceived obstacles will also be discussed.

    World Café Poster Topics:

    • Value Proposition of Implementing QRM Program
    • Senior Leadership Influence of Risk Culture and Empowering Functional Groups to Own Risks
    • Assessing and Measuring Risk Culture
    • Communicating Risk and Using Risk in Decision Making
    • Risk Management Awareness and Mindset at Your Company

     

    11:30 a.m. – 12:00 p.m.
    P2: Academia Influence on ICH Q9-12 Implementation
    Moderator: Ghada N. Haddad, PhD, 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 will look 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.

    11:30 a.m. – 12:00 p.m.
    TUD PhD Programs influencing the ICH Q9-12 Implementation
    Anne Greene, PhD, 
    Professor, Technological University Dublin

    12:00 p.m. – 1:00 p.m.
    Lunch

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

    This session will summarize the cultural characteristics identified by attendees as having the most impact on implementing an effective QRM program. In addition, potential solutions to overcoming potential barriers to establishing an effective risk management program will be presented.

    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 LLC

    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. – 5:30 p.m.
    Workshop 3: Risk Register Infographic
    Moderator: Eva M. Urban, MSc,
    Director Quality Risk Management, CSL Behring

    Teams will develop infographics on elements of a risk register and the infrastructure required for sustainment. Posters will be available for viewing for the remainder of the conference.

    4:00 p.m. – 4:15 p.m.
    Risk Register - "The Why and How"
    Eva M. Urban, MSc,
    Director Quality Risk Management, CSL Behring

    4:15 p.m. – 5:15 p.m.
    Building Maintaining, and Development Value from a Risk Register - Creating a Poster
    The visibility of identified risks and the related risk management process is critical for an organization. A mature QRM program is the foundation to enable risk-based decisions and to build a knowledge data base. A risk register is therefore essential. Teams have the option to work on the different stages and perspectives in establishing and maintaining the risk register. Each team will build a poster to cover one of the following topics:
    Each team will build a poster to cover one of the following topics:

    • The sources of risks to consider end-to-end for a fictional product risk register
    • Layout and design of a fictional product risk register template
    • The infrastructure, process, and governance to sustain a risk register
    • Program to manage product risks embedded in/as a part of the enterprise risk management
    • Risk review and metrics developed from the risk register

    5:15 p.m. – 5:30 p.m.
    Closing Remarks and Adjournment
    Lori Richter, Senior Consultant, ValSource LLC
    Eva M. Urban, MSc, Director Quality Risk Management, CSL Behring

Highlighted Speakers

David M. Churchward
David M. Churchward
MHRA, UK
Anne Greene
Anne Greene
TU Dublin, School of Chemical and Pharmaceutical Sciences
Ghada N. Haddad
Ghada N. Haddad
Merck & Co., Inc.
Lori Richter
Lori Richter
ValSource, LLC
Susan J. Schniepp
Susan J. Schniepp
Regulatory Compliance Associates Inc.
Eva M. Urban
Eva M. Urban
CSL Behring

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

    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
Workshop
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 Nov 15
Workshop
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).

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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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