2019 PDA Building a Foundation and Culture for Quality

2019 PDA Building a Foundation and Culture for Quality Risk Management Integration WorkshopMastering Risk Management for Organizational Success

pda.org/2019Quality

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

RISK MANAGEMENT IN THE REGULATORY LANDSCAPE CONFERENCE: DEC. 9-10OPTIMIZING QUALITY RISK MANAGEMENT CONFERENCE: DEC. 12-13

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FINAL PROGRAM

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Connecting People, Science and Regulation®

GENERAL INFORMATIONREGISTRATION HOURSLocation: Upper Lobby South Wednesday, December 11: 7:00 a.m. – 5:30 p.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 Workshop badge as proof of their registration and permits admission to Sessions and Exhibit Area.

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

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

EXHIBIT AREALocation: Upper Lobby South Wednesday, December 11: 9:15 a.m. – 3:15 p.m.

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2019 PDA Building a Foundation and Culture for Quality Risk Management Integration WorkshopDecember 11, 2019 | Washington, DC

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WEDNESDAY, DECEMBER 117:00 a.m. – 8:00 a.m. ...................... Continental Breakfast8:00 a.m. – 9:30 a.m. ...................... P1: What is a Risk Culture and Why is It Important?9:30 a.m. – 10:00 a.m. ..................... Refreshment Break in Exhibit Area10:00 a.m. – 11:30 a.m. ................... Workshop 1: Breaking the Barriers to a Successful Risk Culture11:30 a.m. – 12:00 p.m. .................. P2: Academic Influence on ICH Q9-12 Implementation12:00 p.m. – 1:00 p.m. ................... Networking Lunch1:00 p.m. – 1:30 p.m. ..................... Workshop 1: Report Out1:30 p.m. – 2:45 p.m. ...................... Workshop 2: Choose Your Own Adventure: Managing Risk Communication2:45 p.m. – 3:15 p.m. ...................... Refreshment Break in Exhibit Area 3:15 p.m. – 4:00 p.m. ...................... Workshop 2: Report Out4:00 p.m. – 5:30 p.m. ...................... Workshop 3: Rick Register Infographic5:30 p.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

Exhibit Area Registration

FEDERAL ABPlenary Sessions

SOUTH AMERICAN ABNetworking Lunch

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WEDNESDAY, DECEMBER 117:00 a.m. – 8:00 a.m. ..................... Continental Breakfast Location: Upper Lobby South

8:00 a.m. – 9:30 a.m. P1: What is a Risk Culture and Why is It Important? Location: Federal AB

Moderator: Steven 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. Welcome and Opening RemarksAnette Yan Marcussen, MPharm, Managing Consultant, NNE A/S

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

9:00 a.m. Q&A Panel

9:30 a.m. – 10:00 a.m. ................. Refreshment Break in Exhibit Area Location: Upper Lobby South

10:00 a.m. – 11:30 a.m. ............... Workshop 1: Breaking the Barriers to a Successful Risk Culture Location: Federal AB

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

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WEDNESDAY, DECEMBER 1111:30 a.m. – 12:00 p.m. ................. P2: Academic Influence on ICH Q9-12 Implementation Location: Federal AB 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. TUD PhD Programs Influencing the ICH Q9-12 Implementation Anne Greene, PhD, Professor, Technological University Dublin

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

1:00 p.m. – 1:30 p.m. .................... Workshop 1: Report Out Location: Federal AB 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 Location: Federal AB 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.

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WEDNESDAY, DECEMBER 112:45 p.m. – 3:15 p.m. ..................... Refresement Break in Exhibit Area

Location: Upper Lobby South

3:15 p.m. – 4:00 p.m. ..................... Workshop 2: Report OutLocation: Federal AB

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 InfographicLocation: Federal AB

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.

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

4:15 p.m. Building, Maintaining, and Developing Value from a Risk Register – Creating a PosterThe 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:

• 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. Closing Remarks and AdjornmentLori Richter, Senior Consultant, ValSource LLCEva M. Urban, MSc, Director Quality Risk Management, CSL Behring

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 2TRAINING COURSES: APRIL 3

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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

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2019 PDA Building a Foundation and Culture for Quality