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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
  • The Americas
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 for two events and save 10% or register for all three and save 15%!


PDA’s Quality Week is devoted to focusing on the principles and applications of Quality Risk Management (QRM). The first conference of week is devoted to the regulatory landscape that outlines the regulatory expectations for establishing a comprehensive risk management program. Attendees to this two-day conference will gain an understanding of the regulatory complexity of QRM principles and how ICH Q9 concepts are being used by industry today to improve and streamline their operations.

Dr. Janet Woodcock, Center Director, CDER, U.S. FDA, will kick off the first day of the event as one of the keynote speakers during the Opening Plenary session. She will discuss the FDA’s perspective on ICH Q9 risk management concepts and how the Agency employs them in their operations.

In addition to Dr. Woodcock’s perspective, Thomas Stanton from Johns Hopkins University will discuss how Enterprise Risk Management can be leveraged successfully within a company’s culture.

The Conference boasts an impressive lineup of speakers, including Martin VanTrieste, CEO, Civica Inc., and Immediate Past Chair, PDA Board of Directors, who explore how risk identification and risk management resulted in the creation of Civica, Inc. Civica was established to address drug shortages through partnering with healthcare systems to ensure that generic drugs are affordable and available as soon as possible.

Dr. Martin Nemec, Health Canada, will focus on risk management concepts from Health Canada’s perspective. Insight into how risk management works when dealing with complex combination products will be provided by Melissa Burns, FDA, and Doug Hamann, AstraZeneca. Guy Villax, CEO, Hovione, and Dr. Lucinda Buhse, FDA, will offer perspective on how risk models are being utilized during inspections and how a good risk management program can result in a positive inspectional outcome.

The second day of this opening Conference will focus on integrating QRM into a company’s quality systems operations. Sessions will delve into how an effective QRM program can assist in evaluating and managing the risk presented when there is a deviation and how QRM can potentially assist in expediting post-approval manufacturing changes.

The second day will also feature a session devoted to exploring the implementation of ICH Q9 from an industry and regulatory perspective. It will look at some of the common pitfalls companies have faced trying to implement ICH Q9 and identify potential improvements for future revisions. Attendees will have an opportunity to learn about the ICH process and offer their ideas on how to improve ICH Q9 through an interactive lunch session featuring two experts who are on the ICH Q9 working group: Gregg Claycamp, FDA, and Stephan Roenninger, Amgen.

The final session for this first of three in this series will discuss Quality Risk Management with respect to high-risk aseptic processing operations, including how QRM can be successfully used as an aid in establishing a comprehensive contamination control strategy.

Don’t miss this first Conference of 2019 PDA Quality Week to gain a better understanding of current QRM global regulatory expectations and how regulatory agencies are using risk-based decisions to determine inspection frequencies and provide oversight.


  • Day 1
  • Day 2
  • Sunday, December 8

    3:00 p.m. – 6:00 p.m.
    Registration Open

    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: Realizing the Power and Potential of Risk Management: A Regulatory Perspective
    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 N. Haddad, PhD, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.,
    Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc.

    8:15 a.m. – 9:00 a.m.
    Enterprise Risk Management: A Powerful Management Tool
    Thomas H. Stanton, MA, JD, Fellow, Johns Hopkins University

    9:00 a.m. – 9:45 a.m.
    FDA Perspective on Realizing the Power and Potential of Risk Management
    Janet Woodcock, MD
    Center Director, CDER, U.S. FDA

    9:45 a.m. – 10:15 a.m.
    Q&A Panel

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

    Poster Presentations
    The following posters will be presented during 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.

    2. A Practical Integration of Quality Risk Management into Deviation and Internal Audit Programs at a Phase 1/ Phase 2 cGMP Biologics Manufacturing Facility
    Adriel P. Ramkissoon, MPhil, BSc,
    QA Compliance Supervisor,,Leidos Biomedical Research 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.
    Risk Management in the Assessment of Quality Submissions for Biologics: Reviewer's Perspective
    Martin Nemec, PhD,
    Senior Biologist/Evaluator, Health Canada

    11:45 a.m. – 12:15 p.m.
    Q&A Panel

    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.
    FDA Perspective: Combination Product Postmarket Requirements and Risk Management
    Melissa B. Burns, MS,
    Senior Program Manager, U.S. FDA

    1:45 p.m. – 2:15 p.m.
    Meeting the Evolving Challenges of Combination Product Risk Management
    Doug Hamann, 
    Compliance Lead – Device & Complaints, AstraZeneca

    2:15 p.m. – 2:45 p.m.
    Q&A Panel

    2:30 p.m. - 5:45 p.m.
    Exhibit Area Open

    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,
     Senior Advisor Quality, Amgen, Inc.

    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.
    No Pills Cheap Phills Full of Compliance or Quality Pills for a Fair Price What Does the Patient Need?
    Guy Villax,
    CEO, Hovione

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

    4:15 p.m. – 4:45 p.m.
    Q&A Panel

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

  • Tuesday, December 10

    7:00 a.m. – 4:45 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, MS, 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.
    Facilitating Continual Improvement, Innovation, and Reducing Drug Shortages through Enhanced Science and Risk-Based Post Approval Change Management
    Anders Vinther, PhD, Global Head of Technical Operations, Intarcia Therapeutics, Inc.

    8:30 a.m. – 9:00 a.m.
    Deviation Investigations and QRM Principles
    Katie A. Link, MA,
    Director, Quality System Site Support, Pfizer Inc. 

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

    9:15 a.m. – 3:00 p.m.
    Exhibit Area Open

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

    10:00 a.m. – 11:30 a.m.
    P6: ICH Q9 Journey: Where are We?
    Moderator: Steven R. Mendivil, Senior Advisor Quality, Amgen, Inc.

    This session will explore ICHQ9 from both the industry and regulatory perspective since its initial implementation on 2005. The session will discuss the maturity level of QRM and tools application in the industry, common pitfalls and potential improvements that can be made to further enhance its benefits. Practical examples on how ICHQ9 can be effectively implemented and most importantly sustained linking quality to protection of the patient will be shared.

    10:00 a.m. – 10:30 a.m.
    Quality Risk Management at 15: Are QRM Resilience and Process Maturity on the Horizon?
    H. Gregg Claycamp, MS, PhD,
    Biologist, CVM, U.S. FDA

    10:30 a.m. – 11:00 a.m.
    15 Years of ICH Q9 Practical implementation & Pitfalls
    Stephan K. Röenninger, PhD, Quality External Affairs, Amgen GmbH

    11:00 a.m. – 11:30 p.m.
    Q&A Panel

    11:30 a.m. – 1:00 p.m..
    Facilitated Roundtable Lunch

    1:00 p.m. – 2:30 p.m.
    P7: Facilitated Roundtable Lunch Recap
    Moderator: Harold S. Baseman, MBA, Chief Operating Officer, ValSource LLC

    1:00 p.m. – 1:30 p.m.
    Driving Stakerholders to Consensus: Unraveling the ICH Process
    Stephan K. Röenninger, PhD, Quality External Affairs, Amgen GmbH

    1:30 p.m. – 2:30 p.m.
    Panel Discussion
    H. Gregg Claycamp, PhD, Biologist, CVM, U.S. FDA
    Marcell Colao, MS, Director, Regulatory & Technical Lifecycle,, GSK Vaccines
    Stephan K. Röenninger, PhD, Quality External Affairs, Amgen GmbH
    Eva M. Urban, MSc, Director Quality Risk Management, CSL Behring

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

    3:00 p.m. – 4:45 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.

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

    3:30 p.m. – 4:00 p.m.
    Why is QRM of Aseptic Processing so Difficult and How to Make it Better?
    Harold S. Baseman, MBA, Chief Operating Officer, ValSource, LLC

    4:00 p.m. – 5:30 p.m.
    Q&A Panel

    4:30 p.m. – 4:45 p.m.
    Closing Remarks and Adjournment
    Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc.


Highlighted Speakers

Andrew D. Hopkins
Andrew D. Hopkins
AbbVie, Inc.
Martin  Nemec
Martin Nemec
Health Canada
Stephan Rönninger
Stephan Rönninger
Amgen Europe
Janeen Skutnik-Wilkinson
Janeen Skutnik-Wilkinson
Thomas H. Stanton
Thomas H. Stanton
Johns Hopkins University
Martin G. VanTrieste
Martin G. VanTrieste
Civica Rx
Janet Woodcock
Janet Woodcock

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

    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

Got a Question? We have answers

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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

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.


Registration Fees

Early Registration
Registration Type Price by Nov 15
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 Nov 15
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 discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].


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