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2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference

Feb 21 - Feb 22, 2017 |
Feb 22, 2017 |
Bethesda North Marriott Hotel & Conference Center | Bethesda, MD
  • Conference
  • Western Hemisphere Events
Exhibition: February 21-22
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Over the past several years, quality metrics have come to figure prominently in the bio/pharmaceutical industry. PDA has been actively involved in the discussion around quality metrics and quality culture since 2013. Since that time, PDA has held three successful Conferences on these topics and contributed comments to the U.S. FDA based, in part, on the outcomes of working group sessions at these events. The FDA has released its revised draft guidance, and PDA is poised to take the lead in continuing the conversation at the 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference.

Be one of the first to learn what has changed in the revised draft guidance and the implications for industry. The 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference builds on the foundation established at the three prior Conferences. Join regulatory and industry experts as they take an in-depth look at the FDA’s newest draft guidance, the benefits to industry and patients, and potential changes to implementation across the various segments of the pharmaceutical industry.

Explore analytical approaches to quality metrics, including how to operationalize metrics to enable continued improvement, and hear firsthand from FDA and industry about utilizing the FDA gateway portal to submit and retrieve metrics data. Regulators will share their perspectives on quality culture, and you will get and update on PDA’s Quality Culture Assessment Pilot and hear directly from pilot participants.

Tuesday, February 21, 2017

7:15 a.m. – 5:30p.m.
Registration Open

7:15 a.m. – 8:30 a.m.
Continental Breakfast

8:15 a.m. – 8:30 a.m.
Welcome and Opening Remarks
Steven R. Mendivil,
Senior Advisor, International Quality External Affairs, Amgen, Inc. and Chair, 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference

8:30 a.m. – 10:00 a.m.
P1: Opening Plenary Session: Quality Metrics Update
Moderator: Susan Schniepp,
Fellow, Regulatory Compliance Associates Inc.

Session Description: This session will highlight FDA's vision, long-term strategy and what has changed in the FDA's new reissued guidance as a result of comments received and both short- and long-term implementation plans. Experts will speak on potential challenges and benefits to the industry and patients.

8:30 a.m. – 9:00 a.m.
FDA's Vision for Quality Metrics
FDA's vision, aspirations and the benefits to the industry and patients will be shared, along with a look at what's new and different in the reissued guidance.
Lawrence Yu, PhD, Deputy Director, Office of Pharmaceutical Quality, OPQ, FDA 

9:00 a.m. – 9:30 a.m.
FDA Update on Reissued Quality Metrics Draft Guidance
Explore the specific details that are new and different in the reissued draft guidance, including metrics, definitions and reporting strategies.
Tara Gooen Bizjak, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA

9:30 a.m. – 10:00 a.m.
Panel Discussion

Lawrence Yu, PhD, Deputy Director, Office of Pharmaceutical Quality, OPQ, FDA
Tara Gooen Bizjak, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA
Mary Malarkey, Director, CBER, FDA
David Churchward, Expert GMP Inspector, Medicines and Healthcare Products Regulatory Agency (Invited)
Todd C. Ebert, MS, President & CEO, Healthcare Supply Chain Association
Alex Viehmann, Operations Research Analyst, CDER, FDA
Sarah Pope Miksinski, PhD, Acting Director, Office of New Drug Quality Assessment, CDER, FDA (Invited)

9:45 a.m. – 6:30 p.m.
Exhibit Area Open

10:00 a.m. – 10:45 a.m.
Refreshment Break in Exhibit Area

10:45 a.m. – 12:15 p.m.
P2: Perspectives on Quality Metrics and the FDA Proposal
Moderator: Steven R. Mendivil,
Senior Advisor, International Quality External Affairs, Amgen, Inc.

Session Description: This session explores benefits and challenges for implementing quality metrics programs. It will focus on the specific challenges posed by the new reissued guidance for various segments of the pharmaceutical industry and will cover proposed solutions to these challenges.

10:45 a.m. – 11:45 a.m.
Panel Discussion
Large Pharma: Barbara Allen, PhD, Senior Director, Global Quality Systems, Eli Lilly and Company, S.A. Irish Branch
Generics: Deborah Autor, Esq., Member, Generic Pharmaceutical Association
API Supplier: Guy Villax, CEO, Hovione
OTC: Carol Montandon, MBA, Chief Quality Officer: Vice President Quality and Compliance, Johnson & Johnson
Biotech: Melissa Seymour, MBA, Vice President, Global Quality Control, Biogen
API/CMO: Harry Jeffreys, VP Regulatory Affairs and Compliance, Catalent Pharma Solutions

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

12:15 p.m. –1:30 p.m.
Networking Luncheon

1:30 p.m. – 3:00 p.m.
P3: Analytical Approaches
Moderator: Pritesh R. Patel, MBA,
Associate Director, Quality Risk Management Statistician, Novartis

Session Description: This session will explore various approaches to metrics analysis, focusing on what the FDA is proposing andindustry's experiences thus far in analyzing quality metrics.

1:30 p.m. – 2:00 p.m.
FDA Update on Metric Analytics
Find out how FDA intends to compile and analyze the metrics data from pharmaceutical companies.
Alex Viehmann, Operations Research Analyst, CDER, FDA

2:00 p.m. – 2:30 p.m.
Operationalizing Metrics to Enable Continuous Improvement: Industry Perspective
Hear firsthand from an industry expert about lessons learned from analyzing quality metrics and how to use metrics to drive continuous improvement and avoid unintended consequences.
Carol Montandon, MBA,Chief Quality Officer: Vice President Quality and Compliance, Johnson & Johnson

2:30 p.m. – 3:00 p.m.
Panel Discussion
Alex Viehmann, Operations Research Analyst, CDER, FDA 
Carol Montandon, MBA, Chief Quality Officer, Vice President, Quality and Compliance, Johnson & Johnson Consumer, Inc.
Tara Gooen Bizjak, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA
Sarah Pope Miksinski, PhD, Acting Director, Office of New Drug Quality Assessment, CDER, FDA (Invited)

3:00 p.m. – 3:45 p.m.
Refreshment Break in Exhibit Area

3:45 p.m. – 5:15 p.m.
P4: Implementation Approaches
Moderator: Jan Paul Zonnenberg, MBA,
Partner, PriceWaterhouseCoopers, LLC

Session Description: This session will explore plans, challenges and proposed solutions for gathering metrics data and navigating the FDA gateway.

3:45 p.m. – 3:55 p.m.
FDA Update on Quality Metrics Data Submission and Collection Strategies
This session will provide an overview of the QM data submission architecture and CDER Informatics Platform.
Seyoum Senay, MS, Lead Informatics Platform – EDM, OBI, FDA

3:55 p.m. – 4:45 p.m.
Panel Discussion
Experts will share their experiences regarding the challenges and solutions for collecting and reporting metrics and using predictive analytics.

Seyoum Senay, MS, Lead Informatics Platform - EDM, OBI, FDA
Pritesh R. Patel, MBA, Associate Director, Quality Risk Management Statistician, Novartis
Robert Chrzanowski, MBA, Sr. Director, Supply Chain Data & Analytics, Johnson & Johnson (Invited)
Machelle Eppler, Vice President and Head of Global Quality Compliance & Regulatory, Patheon 
Richard Love, Founder, HarborView, LLC
Tom Foth, Director, Analytic Application Concept Development, PriceWaterhouseCoopers LLC
Thomas Friedli, Associate Professor of Management, University of St. Gallen

4:45 p.m. – 5:15 p.m.
Questions and Answers/Discussion

5:15 p.m. - 6:30 p.m.
Networking Reception in Exhibit Area

Wednesday, February 22, 2017

7:15 a.m. – 4:00p.m.
Registration Open

7:15 a.m. – 8:15 a.m.
Continental Breakfast

8:15 a.m. – 9:45 a.m.
P5: Quality Culture and What We are Learning as an Industry
Moderator: Cylia Chen Ooi,
External Affairs Sr. Manager, International Quality, Amgen, Inc.

Session Description: This session will explore quality culture within the pharmaceutical industry and what we are learning about the relationship between quality metrics and quality culture.

8:15 a.m. – 8:45 a.m.
Quality Culture and Risk Management Behaviors (FDA)
Quality systems and quality metrics are elements of a complex environment where key decisions are also impacted by an organization's Quality Culture. Understanding and managing Quality Culture is critical to effective risk management and an emerging consideration in control strategy development and assessment.
Jeffrey C. Baker, PhD, Deputy Director, Office of Biotechnology Products, CDER, FDA

8:45 a.m. – 9:15 a.m.
Regulatory Perspective on Quality Culture (MHRA)
MHRA will share its thoughts on the importance of quality culture and how to assess it.
David Churchward, Expert GMP Inspector, Medicines and Healthcare Products Regulatory Agency (Invited)

9:15 a.m. – 9:45 a.m.
Panel Discussion
Jeffrey C. Baker, PhD, Deputy Director, Office of Biotechnology Products, CDER, FDA
David Churchward, Expert GMP Inspector, Medicines and Healthcare Products Regulatory Agency (Invited)

9:30 a.m. – 3:45 p.m.
Exhibit Area Open

9:45 a.m. – 10:30 a.m.
Refreshment Break in Exhibit Area

10:30 a.m. – 12:15 p.m.
P6: What Moves the Needle for Maturing Quality Culture?
Moderator: Robert D. McElwain,
Consumer Safety Officer, CBER, FDA

Session Description: What has executive management used to mobilize and dramatically improve a company’s quality culture?

10:30 a.m. – 10:55 a.m.
What Drives Quality Culture: A CEO's Perspective
Guy Villax,
CEO, Hovione

10:55 a.m. – 11:20 a.m.
Innovative Approaches to Transforming Quality Culture
Anders Vinther, PhD,
Chief Quality Officer, Sanofi Pasteur

11:20 a.m. – 11:45 a.m.
Appreciating Successes to Drive a Quality Culture
Gerhard Köller, PhD, Chief Quality Officer, Boehringer Ingelheim (Invited)

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

12:15 p.m. – 1:30 p.m.
Networking Luncheon

1:30 p.m. – 3:00 p.m.
P7: Assessing Quality Systems and Quality Culture
Moderator: Marci Goldfinger, MS,
Director QA Integration, Johnson & Johnson Inc, US OTC

Session Description: Assessing quality culture is difficult. Get an update on PDA's Quality Culture Assessment Pilot Program and academic approaches to measuring quality culture.

1:30 p.m. – 1:50 p.m.
Aspiring to Measure Quality Culture
Hear the latest on PDA's Quality Culture Assessment Pilot Program.
Cylia Chen Ooi, External Affairs Sr. Manager, International Quality, Amgen, Inc.

1:50 p.m. – 2:10 p.m.
A Company's Experience in the PDA Quality Culture Assessment Pilot Program
This session provides a firsthand account of users' experiences with this new tool during PDA's pilot program.
Machelle Eppler, Vice President and Head of Global Quality Compliance & Regulatory, Patheon

2:10 p.m. – 2:30 p.m.
An Academic Perspective on Measuring Quality Systems and Quality Culture
Thomas Friedli,
Associate Professor of Management, University of St. Gallen

2:30 p.m. – 3:00 p.m.
Panel Discussion
Cylia Chen Ooi, External Affairs Sr. Manager, International Quality, Amgen, Inc.
Machelle Eppler, Vice President and Head of Global Quality Compliance & Regulatory, Patheon
Thomas Friedli, Associate Professor of Management, University of St. Gallen
Jan Paul Zonnenberg, MBA, Partner, PriceWaterhouseCoopers, LLC
Brianna Peterson, Project Management Office, Corporate Division Quality Projects, Boehringer Ingelheim

3:00 p.m. – 3:45 p.m.
Refreshment Break in Exhibit Area

3:45 p.m. – 5:15 p.m.
P8: Closing Plenary: Quality Metrics and Quality Culture Wrap up
Moderator: Mary Malarkey, Director, CBER, FDA

Session Description: This closing session will summarize the future of quality metrics and discuss quality culture as an enabler of continuous improvement in the pharmaceutical manufacturing industry.

3:45 p.m. – 4:05 p.m.
CDRH's Case for Quality and Quality Metrics
CDRH will share its approach to quality metrics.
William MacFarland, MS, MBA, Supervisory Biomedical Engineer, FDA

4:05 p.m. – 4:25 p.m.
PDA Quality Metrics/Quality Culture Next Steps
Learn about PDA's short- and long-term plans for quality metrics and quality culture.
Steven R. Mendivil, Senior Advisor, International Quality External Affairs, Amgen, Inc.

4:25 p.m. – 4:45 p.m.
Quality Metrics: Next Steps
CDER/CBER will discuss their short- and long-term plans for quality metrics and quality culture.
Ashley Boam, MSBE, Acting Director, Office of Policy for Pharmaceutical Quality, CDER, FDA (Invited)

4:45 p.m. – 5:15 p.m.
Questions and Answers/Discussion
William MacFarland, MS, MBA, Supervisory Biomedical Engineer, FDA (Invited)
Steven R. Mendivil, Senior Advisor, International Quality External Affairs, Amgen, Inc.
Ashley Boam, MSBE, Acting Director, Office of Policy for Pharmaceutical Quality, CDER,FDA (Invited)
Tara Gooen Bizjak, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA
Alex Viehmann, Operations Research Analyst, CDER, FDA

5:15 p.m.
Closing Remarks
Richard M. Johnson,
President & CEO, PDA

Conference Registration | February 21-22, 2017

Member

Before December 12, 2016
$1,895

December 12, 2016 – January 6, 2017
$2,095

After January 6, 2017
$2,295

Non-member

Before December 12, 2016
$2,174

December 12, 2016 – January 6, 2017
$2,374

After January 6, 2017
$2,574


Government/Health Authority/Academic

Member

Before December 12, 2016
$700

December 12, 2016 – January 6, 2017
$700

After January 6, 2017
$700

Non-member*

Before December 12, 2016
$800

December 12, 2016 – January 6, 2017
$800

After January 6, 2017
$800


Student

Member

Before December 12, 2016
$280

December 12, 2016 – January 6, 2017
$280

After January 6, 2017
$280

Non-member*

Before December 12, 2016
$310

December 12, 2016 – January 6, 2017
$310

After January 6, 2017
$310


All prices in US dollars.

* For this member type, online registration is not available must be faxed in.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund and photo release policies for this Conference.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Conference and receive the 5th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may accommodate. Please contact us at registration@pda.org for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by December 23, 2016 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Conference: If your written request in received on or before December 23, 2016, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Recordings are prohibited at all PDA Conferences.

Bethesda North Marriott HotelBethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
North Bethesda, MD 20852
Phone: +1 (301) 822-9200
Call for reservations and ask for "PDA Metrics Conference" rate.

Rate: $199
Cut Off Date: February 6, 2017

The 2017 PDA Pharmaceutical Metrics and Quality Culture Conference will provide your company exclusive exhibit and sponsorship opportunities to gain access to and network with key decision makers from the pharmaceutical and biotech manufacturing industry. Attendees will include industry professionals from quality, compliance, manufacturing, operations, technical functions, and supply chain.

Network, Collect Intelligence and Forge Key Relationships

With multiple networking breaks, sit down luncheon, and reception, you have ample time to connect with your desired audience of industry leaders. Your tabletop exhibit package includes one full conference registration, one exhibit only badge, company listing on the conference website and in the on-site exhibit guide, six foot skirted table, chair, trash can, and personal on-site assistance.

Increase Brand Recognition

Become a sponsor at the conference to strengthen your brand image, increase your visibility, and align your company with industry leading minds and world class content. High profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, refreshment breaks, lunch and networking reception. We’ll create a customized sponsorship to fit your needs and budget.

For more information about exhibit and sponsorship opportunities, please contact David Hall at +1 (301) 656-5900 ext. 160; cell +1 (240) 688-4405; hall@pda.org or Alison Caballero at +1 (301) 656-5900 ext. 135; caballero@pda.org.

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