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2019 PDA Risk Management in the Regulatory Landscape Conference

Dec 09 - Dec 10, 2019
Washington, DC

Mastering Risk Management for Organizational Success

  • Conference
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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 Risk Management in the Regulatory Landscape Conference will cover the current QRM global regulatory expectations and how regulatory agencies are using risk-based decisions to determine inspection frequencies and provide oversight.

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

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PDA’s inaugural Quality Week will tackle the complex subject of Quality Risk Management. In this first event of the week, the focus will be on the emerging regulatory landscape, framing the requirements and objectives of the regulations that govern this important but elusive concept from industry and regulators’ perspectives.

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
  • Monday, December 9

    7:00 a.m. – 5:45 p.m.
    Registration Open

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

    8:00 a.m. – 10:15 a.m.
    P1: Opening Plenary
    Moderator: Tina S. Morris, PhD, Vice President, Scientific & Regulatory Affairs, Parenteral Drug Association

    The opening plenary brings together two compelling perspectives on the power and potential of risk management – across the international pharmaceutical space, as codified by ICH Q9, but also domestically as a tool employed by Federal Agencies. Dr. Janet Woodcock will discuss how the FDA currently views the application and future potential of risk management approaches – has the potential of QRM been fully realized, yet, and where are we on the journey to fully leverage the paradigms laid out in ICH Q9 and Q10? Thomas Stanton, Author of Public Sector Enterprise Risk Management, will provide a perspective on the journey of introducing and successfully establishing acceptance of ERM concepts in the federal government context.

    8:00 a.m. – 8:15 a.m.
    Welcome and Opening Remarks
    2019 PDA Quality Week Program Planning Committee Co-Chairs
    Ghada Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc., and
    Sue J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    8:15 a.m. – 9:00 a.m.
    Thomas Stanton, Author, Enterprise Risk Management (ERM): A Powerful Federal Management Tool

    9:00 a.m. – 9:45 a.m.
    Janet Woodcock, MDDirector, CDER, FDA

    9:45 a.m. – 10:15 a.m.
    Questions and Answers/Discussion

    10:15 a.m. – 10:45 a.m.
    Refreshment Break and Poster Presentations

    Poster Presentations
    The following posters will be presented during today’s refreshment breaks and the networking reception

    1. Benefits of Using Quality Risk Management Proactively During Facility Design
    Adam M. Caruso, MBA,
    Associate Director, Quality Risk Management Center of Excellence,Merck & Co., Inc.


    10:45 a.m. – 12:15 p.m.
    P2: The Global Perspective on QRM
    Moderator: Harold S. Baseman, MBA, Chief Operations Officer, ValSource, LLC

    There are good reasons and strong expectations for our industry to use QRM principles to make sound, informed, and better decisions related to the control of manufacturing processes, the prioritization of resources, and the supply of quality products. This session will explore current and on-going expectations, opportunities, challenges, and solutions for the use of QRM principles from the perspective and practical experience of health authority and industry experts.

    10:45 a.m. – 11:15 a.m.
    Risk Identification and Management Led to the Creation of Civica
    A Transformative – Disruptive Company Serving Patients by Delivering Quality Medicines that are Available and Affordable
    Martin G. VanTrieste, BS Pharmacy, President & CEO, Civica Inc.

    11:15 a.m. – 11:45 a.m.
    Martin Nemec, PhD, Senior Biologist/Evaluator, Health Canada

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    12:15 p.m. – 1:15 p.m.

    1:15 p.m. – 2:45 p.m.
    P3: Quality Risk Management for Combination Products
    Moderator: Denyse D. Baker PE, RAC,  Senior Director of Regulatory Policy, AstraZeneca

    As biopharma companies work to deliver optimal solutions for patients, more drug and biologic products are coming to market in combination with delivery devices, wearable electronics, or mobile apps. The complexities of drug or biologic-to-device and patient-to-device interfaces create new risks that must be appropriately managed by manufacturers. This session will feature FDA and industry experts discussing current regulatory expectations, including the new U.S. FDA guidance on Post-market Safety Reporting, and practical examples of using risk information in the manufacturing and quality systems for combination products.

    1:15 p.m. – 1:45 p.m.
    Melissa Burns, U.S. FDA

    1:45 p.m. – 2:15 p.m.
    Doug Hammnn, Compliance Lead – Device & Complaints, AstraZeneca

    2:15 p.m. – 2:45 p.m.
    Questions and Answers/Discussion

    2:45 p.m. – 3:15 p.m.
    Refreshment Break and Poster Presentations

    3:15 p.m. – 4:45 p.m.
    P4: Risk Models used by Regulators
    Moderator: Steve R. Mendivil, BS,
    Independent Consultant

    The FDA is using risk principles in several different programs including: Inspectional Risk Models, and Drug Shortage Program. Explore the risk principles being utilized and how those might be developed to focus FDA's resources and efforts to assess and addressing quality and compliance issues at global manufacturing sites that impact patient safety and drug availability. The pharmaceutical manufacturing industry utilities metrics, assessments and other risk principles in preventing quality and drug shortage issues. This session explores how those can help prevent quality and drug shortage issues and how those might be shared with regulators to be considered a "low risk manufacturing site" and its potential benefits.

    3:15 p.m. – 3:45 p.m.
    Guy Villax, CEO, Hovione

    3:45 p.m. – 4:15 p.m.
    Lucinda Buhse, PhD, Director, OPQ/Office of Surveillance, CDER, U.S. FDA

    4:15 p.m. – 4:45 p.m.
    Questions and Answers/Discussion

    4:45 p.m. – 5:45 p.m.
    Networking Reception

  • Tuesday, December 10

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

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

    8:00 a.m. – 9:30 a.m.
    P5: Integration of QRM into Quality Systems
    Moderator: Marcello Colao, MD, Director, Regulatory & Technical Lifecycle,GSK Vaccines

    Quality Risk Management (QRM) is a key enabler of the Pharmaceutical Quality System. This session explores how QRM principles can be integrated into two critical Quality systems such as Change Control and Deviation Management; more specifically this session will explore how QRM can facilitate the management of Post-Approval Changes during lifecycle in order to foster continual improvement and innovation, and how it can be used as a strong foundation to build an effective Deviation Management system.

    8:00 a.m. – 8:30 a.m.
    Solving the Global Continual Improvement and Innovation Challenge: A Risk-Based Approach to Management of Post-Approval Changes
    Emma Ramnarine, Global Head External Development Collaborations, Roche, and
    Anders Vinther, Head of Quality, Intarcia

    8:30 a.m. – 9:00 a.m.
    QRM as Key Foundation for an Effective Deviation Management System
    Katie Link,
    Director Quality Systems Site Support, Pfizer Inc,

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

    9:15 a.m. – 3:30 p.m.
    Exhibit Area Open

    9:30 a.m. – 10:15 a.m.
    Refreshment Break and Poster Presentations

    10:15 a.m. – 11:45 a.m.
    P6: ICH Q9
    Moderator: Magaly E. Aham, Senior Director Quality Compliance, Millennium, The Takeda Oncology Co.

    10:15 a.m. – 10:45 a.m.
    H. Gregg Claycamp, PhD, Biologist, CVM, U.S. FDA

    10:45 a.m. – 11:15 a.m.
    15 Years of ICH Q9 Practical implementation & Pitfalls
    Stephan K. Roenninger, PhD, Quality External Affairs, Amgen GmbH

    11:15 a.m. – 11:45 p.m.

    Questions and Answers/ Discussion

    11:45 a.m. – 1:15 p.m..
    Facilitated Roundtable Lunch

    1:15 p.m. – 2:45 p.m.
    P7: Facilitated Roundtable Lunch Recap
    Moderator: Magaly E. Aham, MSc,Head Knowledge Management, Takeda

    1:15 p.m. – 1:45 p.m.
    Driving Stakerholders to Consensus: Unraveling the ICH Process
    Janeen A. Skutnik-Wilkinson, Associate Director, Quality Intelligence, Biogen

    1:45 p.m. – 2:45 p.m.
    Panel Discussion
    H. Gregg Claycamp, PhD, Biologist, CVM, U.S. FDA
    Stephan K. Roenninger, PhD, Quality External Affairs, Amgen GmbH

    2:45 p.m. – 3:15 p.m.
    Refreshment Break and Poster Presentations

    3:30 p.m. – 5:15 p.m.
    P8: Quality Risk Management in Aseptic Processing
    Moderator: Jaap Venema, PhD, Chief Science Officer, U.S. Pharmacopeia (USP)

    Aseptic processes can be some of the most difficult processes to conduct in the pharmaceutical industry. If not properly controlled, aseptic processes present a significantly higher risk than terminally sterilization processes. An effective risk-management program is critical in the careful control of the process, reducing the risk of loss of sterility as well as ensuring a commensurate approach to risk management based on the potential risk to the patient. This session provides industry perspectives on the regulatory expectations, challenges and opportunities for improvement in controlling aseptic processing.

    3:30 p.m. – 4:00 p.m.
    Regulatory Requirements for QRM and the Link to the Contamination Control Strategy
    Andrew Hopkins, Director, Operation Quality QA Audit and compliance, AbbVie, Inc.

    4:00 p.m. – 4:30 p.m.
    Why is QRM of Aseptic Processing so Difficult and How to Make it Better?
    Harold S. Baseman, Chief Operations Officer, ValSource, LLC

    4:30 p.m. – 5:00 p.m.
    Questions and Answers/ Discussion

    5:00 p.m. – 5:15 p.m.
    Closing Remarks and Adjournment
    Ghada Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., 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.

  • 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, 25 miles away, and Baltimore-Washington International, 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 $1,995
Non-member $2,274
Young Professional Member $998
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 $2,595
Non-member $2,874
Young Professional Member $1,298
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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