2019 pda optimizing quality risk management conference

2019 PDA Optimizing Quality Risk Management ConferenceMastering Risk Management for Organizational Success

pda.org/2019Quality

DECEMBER 12-13 | WASHINGTON, DCEXHIBITION: DEC. 9-11

RISK MANAGEMENT IN THE REGULATORY LANDSCAPE CONFERENCE: DEC. 9-10BUILDING A FOUNDATION AND CULTURE FOR QUALITY RISK MANAGEMENT INTEGRATION WORKSHOP: DEC. 11

#PDAQualityWeek

FINAL PROGRAM

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Connecting People, Science and Regulation®

GENERAL INFORMATIONREGISTRATION HOURSLocation: Upper Lobby South Thursday, December 12: 7:00 a.m. – 5:30 p.m.Friday, December 13: 7:00 a.m. – 11:45 a.m.

WIFI INFORMATIONNetwork Name/SSID: HILTON_MEETINGSPassword: QRM2019 (case sensitive)

RECOMMENDED ATTIREBusiness casual attire is recommended for all events. The temperature in the meeting rooms tends to be cool, so a jacket or sweater is advised for your comfort.

BADGESAttendees are required to wear their Conference badge as proof of their registration and permits admission to Sessions and the Networking Reception.

VENUEPDA will conduct all of the sessions and events at the Capital Hilton.

NETWORKING RECEPTIONAll registered attendees are welcome to attend Thursday evening’s Networking Reception.

SPECIAL REQUIREMENTSFor information regarding special needs accommodations, please inquire at the Registration Desk. PDA is committed to make all events accessible to all individuals.

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2019 PDA Optimizing Quality Risk Management ConferenceDecember 12-13, 2019 | Washington, DC

#PDAQualityWeek

THURSDAY, DECEMBER 127:00 a.m. – 8:00 a.m. ...................... Continental Breakfast 8:00 a.m. – 10:00 a.m. .................... P1: Harnessing the Power of Quality Risk Management 10:00 a.m. – 10:30 a.m. ................... Refreshment Break and Poster Presentations10:30 a.m. – 12:00 p.m. .................. P2: Quality Risk Management as a Strategic Driver in the Organization12:00 p.m. – 1:00 p.m. ................... Networking Lunch1:00 p.m. – 2:30 p.m. ..................... P3: Deploying QRM – Part 12:30 p.m. – 3:00 p.m. ..................... Refreshment Break and Poster Presentations3:00 p.m. – 4:30 p.m. ...................... P4: Deploying QRM – Part 24:30 p.m. – 5:30 p.m. ...................... Networking Reception

FRIDAY, DECEMBER 137:00 a.m. – 8:00 a.m. ...................... Continental Breakfast8:00 a.m. – 9:30 a.m. ...................... P5: QRM Application in Cell and Gene Therapy and Biologics – From Organization ..................................................... to Execution9:30 a.m. – 10:00 a.m. .................... Refreshment Break and Poster Presentations10:00 a.m. – 11:45 a.m. .................. P6: Fireside Chat with Regulators and Industry Experts11:45 a.m. ....................................... Adjournment

SCHEDULE-AT-A-GLANCE

*Session locations can be found within the agenda

THANK YOU TO THE PROGRAM PLANNING COMMITTEE

Program Co-Chairs

Program Committee

PDA Staff

Magaly E. Aham, MSc, Takeda

Denyse D. Baker, PE, RAC, AstraZeneca

Harold S. Baseman, MBA, ValSource LLC

Marcello Calao, MS, GSK Vaccines

Andrew D. Hopkins, BSc, Hon PGDip, AbbVie, Inc.

Anette Yan Marcussen MPharm, NNE A/S

Steven R. Mendivil, BS, Amgen, Inc.

Lori Richter, ValSource LLC

Janeen A. Skutnik-Wilkinson, Biogen

Eva M. Urban, MSc, CSL Behring

Jason M. Urban, PhD, CA-AM, Bristol-Myers Squibb

Jaap Venema, PhD, U.S. Pharmacopeia (USP)

Annette BacchusRuth K. Miller, JDTina S. Morris, PhD

Ghada N. Haddad, PhD, Merck & Co., Inc.

Susan J. Schniepp, BS, Regulatory Compliance Associates, Inc.

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CONFERENCE FLOOR PLAN

FUNCTION

UPPER LOBBY SOUTHContinental Breakfast Poster Presentations

Registration

FEDERAL ABPlenary Sessions

SOUTH AMERICAN ABNetworking Lunch

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THURSDAY, DECEMBER 127:00 a.m. – 8:00 a.m. ................... Continental Breakfast ...................................................... Location: Upper Lobby South

8:00 a.m. – 10:00 a.m. ................ P1: Harnessing the Power of Quality Risk Management Location: Federal AB

Moderator: Steven R. Mendivil, BS, Senior Advisor Quality, Amgen, Inc.

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. Welcome and Opening RemarksHarold S. Baseman, MBA, Chief Operating Officer, ValSource LLC Jason M. Urban, PhD, CA-AM, Head of External Engagement Global Quality, Bristol-Myers Squibb

8:15 a.m. Opportunities to Harness the Power of Quality Risk Management Anil Sawant, MSc, PhD, Senior Vice President, Global Quality Compliance, Merck & Co., Inc.

9:00 a.m. Supply Chain Risk Quality Risk Managment: Real Life Examples and Risk-Based Approaches Rebecca E. Dombrowski, MS, Senior Policy Advisor, CDER, U.S. FDA

9:45 a.m. Q&A Panel

10:00 a.m. – 10:30 a.m. ............... Refreshment Break and Poster Presentations Location: Upper Lobby South

Poster Presentations The following posters will be presented during refreshment breaks.

POSTER #

Create and Use a Custom Risk Management ToolRandy Friedman, Principal, Quality Risk Management Specialist, Genentech, Inc.

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The Vision of QRM into QMS(Quality Risk Management into Quality Management System)Sofia van Berlekom, MSc, Global Quality Director, Corporate Quality & Strategy, AstraZeneca

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10:30 a.m. – 12:00 p.m. ............... P2: Quality Risk Management as a Strategic Driver in the Organization Location: Federal AB

Moderators: Eva M. Urban, MSc, Director Quality Risk Management, CSL Behring

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 product quality and the safety to the patient.

10:30 a.m. QRM at AstraZeneca Operations: A Journey Sofia van Berlekom, MSc, Global Quality Director, Corporate Quality & Strategy, AstraZeneca

10:45 a.m. Raising the Bar – Embedding Quality Risk Management Processes across the GxP Continuum

Jason M. Urban, PhD, CA-AM, Head of External Engagement Global Quality, Bristol-Myers Squibb

11:00 a.m. Implementing a QRM Program Heather A. Crews, BS, Associate Director, Quality Risk Management, Merck & Co., Inc.

11:15 a.m. QRM Integration in Novo Nordisk A/S Michael Schousboe, Msc Pharm, Principal Specialist, Quality Risk Management, Novo Nordisk A/S

11:30 a.m. Q&A Panel

12:00 p.m. – 1:00 p.m. ................. Networking Lunch Location: South American AB


THURSDAY, DECEMBER 12

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THURSDAY, DECEMBER 121:00 p.m. – 2:30 p.m. .................... P3: Deploying QRM – Part 1 Location: Federal AB Moderator: Steven R. Mendivil, BS, Senior Advisor Quality, Amgen, Inc.

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 will explore 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. The Pendulum Swings Both Ways: QRM Deployment that Aligns with Your Quality Culture

Amanda M. McFarland, MS, Senior QRM Consultant, ValSource LLC

1:30 p.m. Beyond the Regulations: The ANSI Standard ProcessSusan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc.

2:00 p.m. Q&A Panel

2:30 p.m. – 3:00 p.m. .................... Refreshment Break and Poster Presentations Location: Upper Lobby South

3:00 p.m. – 4:30 p.m. ..................... P4: Deploying QRM – Part 2 Location: Federal AB 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. IPEC-PDA Tech Report 54-6 Risk Assessment for Excipients: Case Study: End-to-End “Risk Assessment and It’s Challenges” Eva M. Urban, MSc, Director Quality Risk Management, CSL Behring

3:30 p.m. PDA Tech Report 54-5: QRM for Manufacturing Systems: QRM as a Source Knowledge Kelly Waldron, PhD, Senior Consultant, ValSource LLC

4:00 p.m. Q&A Panel

4:30 p.m. – 5:30 p.m. ..................... Networking Reception Location: North Gate Grill The North Gate Grill is located down one level, in the hotel lobby.

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FRIDAY, DECEMBER 137:00 a.m. – 8:00 a.m. ..................... Continental Breakfast ...................................................... Location: Upper Lobby South

8:00 a.m. – 9:30 a.m. ..................... P5: QRM Application in Cell and Gene Therapy and Biologics – From ............................................ Organization to Execution Location: Federal AB Moderator: Jason M. Urban, PhD, CA-AM, Head of External Engagement Global Quality, Bristol-Myers Squibb

A one-size fits all approach to application of quality risk management can be limiting and lead to operational inefficiencies and ineffectiveness down the road. Taking this into account and compounding it with the latest revolution in medicine manufacturing we need to look at ways to adapt current tools to “fit for purpose”, as well as, take a deeper look at the organization and its readiness to move in the direction of an adaptable QRM program. This session will provide valuable information on the application of risk management tools across the lifecycle of cell therapy production, as well as, insights and approaches to assessing the maturity level of QRM at pharmaceutical facilities and organizations.

8:00 a.m. How Different Quality Risk Management Tools Can Be Used during the Lifecycle of an ATMP Product

Monica Hueg, MSSc, Managing Consultant, NNE

8:30 a.m. QRM Maturity Assessment – The Great AllyTais H. Conti, MA, Quality Systems and Compliance Senior Manager, Bristol-Myers Squibb

9:00 a.m. Q&A Panel

9:30 a.m. – 10:00 a.m. ................... Refreshment Break and Poster Presentations Location: Federal AB

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10:00 a.m. – 11:45 a.m. ................. P6: Fireside Chat with Regulators and Industry Experts Location: Upper Lobby South Moderators: Ghada N. Haddad, PhD, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.

Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc.

Leading regulators and industry representatives give their perspective on the use of quality risk management (QRM) and practical aspects of QRM.

10:00 a.m. State of QRM Implementation: Current Challenges and Successes Rick L. Friedman, Deputy Director, Science and Policy, OMPQ, CDER, U.S. FDA

10:30 a.m. Panel DiscussionMichael Blackton, Vice President, Quality, Addaptimmune LLCMary Farbman, PhD, Executive Director, Compliance Remediation and Support, Merck & Co., Inc.Rick L. Friedman, PDeputy Director, Science and Policy, OMPQ, CDER, U.S. FDAAndrew D. Hopkins, BSc, Hon PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie, Inc.Lori Richter, Senior Consultant, ValSource LLC

11:30 a.m. Closing Remarks and Final Wrap-Up from Conference Co-ChairsGhada N. Haddad, PhD, Executive Director, Global CGMP & Compliance Auditing Organization, Merck & Co., Inc.Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc.

FRIDAY, DECEMBER 13

2020 PDA Annual MeetingREGISTER BY JAN. 30, 2020 AND SAVE UP TO $600

pda.org/2020Annual

MARCH 30-APRIL 1 | RALEIGH, NCEXHIBITION: MARCH 30-APRIL 1

2020 PDA PHARMACEUTICAL MANUFACTURING DATA SCIENCE WORKSHOP: APRIL 2 TRAINING COURSES: APRIL 2

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Don’t miss the early registration deadline!The 2020 PDA Annual Meeting is looking to the future of pharmaceutical manufacturing by examining how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes.

CALLING ALL YOUNG PROFESSIONALS

Meet other ambitious life science professionals entering the field and build strong business connections with established leaders.

Attend special sessions and networking events planned with YOU in mind.

This Conference is shaping up to be an eye-opening look into the promising future of pharmaceutical manufacturing.

To learn more and register, visit pda.org/2020Annual

2019 pda optimizing quality risk management conference

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