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2019 Data Integrity Workshop

2019 PDA Data Integrity Workshop

Sep 18 - Sep 19, 2019
Washington, DC

Navigating the Data Integrity Journey

  • Workshop
  • Conference
  • The Americas

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Program Highlights

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Important Dates: Register by July 30 and save up to $200!

Overview

Data Integrity continues to be a major concern for Health Authorities and the pharmaceutical industry. Even though data integrity has been a requirement for years, recently there has been an increased focus on this topic both from a regulatory and industry perspective and Data Integrity has been the focus of numerous recent Health Authority enforcement actions such as Warning Letters, Import Alerts, product quarantines, and suspension or revocation of Marketing Authorizations. In addition, more guidelines and regulations have been published to establish Data Integrity Standards.

As Data Integrity programs mature, we need to transition from a reactive mode to a preventative mode and engrain Data Integrity into our Quality Management System and Culture. This conference will be comprised of interactive case studies, presentations, and roundtable discussions.

Agenda

  • Day 1
  • Day 2
  • Wednesday, September 18

    11:30 a.m. – 6:30 p.m.
    Registration Open

    1:45 p.m. – 2:00 p.m.
    Welcome and Opening Remarks from Conference Co–Chair
    Jackie Veivia-Panter, Senior Director, Quality Systems and Compliance, Legend Biotech

    2:00 p.m. – 3:30 p.m.
    P1: Overcoming the Data Integrity Challenges
    Moderator: Ronald F. Tetzlaff, PhD, Corporate Vice President, PAREXEL International

    This session is designed to understand the current state of Data Integrity from the regulators and industry perspective. Subject matter experts will present current thinking on the subject. Regulators will share their findings and continued concerns. They will discuss current guidance and where we need to transition as an industry. Industry will present challenges of remediation efforts, what failed, and what they would have done differently. Participants will have opportunity to exchange ideas during the Q&A following the speaker presentations.

    2:00 p.m. – 2:30 p.m.
    Where Does Data Integrity Start and End? Understanding Data Integrity Expectations throughout a Drug Product’s Lifecycle
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA

    2:30 p.m. – 3:00 p.m.
    The Data Integrity Challenges Around the Transition from Paper to Digital
    Els Poff, Executive Director, Data Integrity Center of Excellence, Merck & Co., Inc.

    3:00 p.m. – 3:30 p.m.

    Panel Discussion with Speakers and Additional Panelists
    David M. Churchward, MSc, Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), MHRA, UK
    Aditi S. Thakur, MS, Acting Quality Assessment Lead, Office of Pharmaceutical Quality, CDER, FDA

    3:15 p.m. – 6:30 p.m.
    Exhibit Area Open

    3:30 p.m. – 4:00 p.m.
    Refreshment Break in Exhibit Area

    4:00 p.m. – 5:30 p.m.
    P2: Pragmatic Applications of Quality Risk Management to Data Integrity
    Moderator: Amanda Bishop McFarland,
    Senior Consultant, ValSource, LLC

    On the second stop of our workshop journey, we will evaluate data integrity through the lens of Quality Risk Management. Data management is a rapidly evolving discipline with the initiation of electronic data gathering, cloud technologies, and automation. The need to both identify and remediate data integrity risks has become a regulatory focal point. This session will provide insight into the Quality Risk Management and Data Integrity regulatory expectations and what these expectations look like when they are put into practice.

    4:00 p.m. – 4:30 p.m.
    Regulatory Perspective on Pragmatic Quality Risk Management for Data Integrity
    David M. Churchward, MScDeputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), MHRA, UK

    4:30 p.m. – 5:00 p.m.
    Risk-Based Approach to Data Integrity in Manufacturing and Testing Sites
    John Grealis, PhD, Regional Head Data Integrity, Novartis

    5:00 p.m. – 5:30 p.m.
    Panel Discussion with Speakers and Additional Panelists
    Peter E. Baker, MS,
    Vice President, Green Mountain Quality Assurance and formerly with the FDA
    Tom Cosgrove, JD, Partner, Covington & Burling LLP and formerly with the FDA
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA

    5:30 p.m. – 6:30 p.m.
    Networking Reception




  • Thursday, September 19

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

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

    7:15 a.m. – 8:15 a.m.
    Breakfast Session: The Intersection Between Mindfulness and Data Integrity (Sponsored by Ultragenyx Pharmaceutical) 
    Moderator: Monica Cahilly, Consultant/President, Green Mountain Quality Assurance LLC

    Data integrity issues, whether unintentional human error or intentional, will never disappear completely. People are complex and driven by many motivations. However, the industry can respond in a more holistic way to both understand and address these issues. Understanding the human element is a critical piece to address Data Integrity lapses. Mindfulness is a tool that can help you and your teams create capacity and focused awareness. By introducing the ability to pause during stressful situations, we can achieve thoughtful responses versus stress or fear-induced reactions. Can we expand our line of sight to include mindfulness and meditation in addition to the usual tactile tools already in place for ensuring good decision making with regard to data integrity?

    This breakfast session will explore the neuroscience of human behavior, mindfulness, and the connection to data integrity. This session will include a presentation, a short mindfulness practice, and then end with Q&A

    7:15 a.m. – 7:45 a.m.
    Amy L. McLaren, Senior Director, Quality and Compliance, Ultragenyx Pharmaceutical
    Julie C. Maurhoff, CQA, Senior Director GxP Compliance, Ultragenyx Pharmaceutical   

    7:45 a.m. – 7:55 a.m.
    Practice Exercise

    7:55 a.m. – 8:15 a.m.
    Questions and Answers/Discussion     

    8:30 a.m. – 10:00 a.m.
    P3: How Do You Apply Data Integrity Concepts Over the Lifecycle of a Product?
    Moderator: Monica Cahilly, President/Consultant, Green Mountain Quality Assurance Group, LLC

    Just as industry and regulators have discussed phase appropriate GMPs throughout the years, are there phase appropriate Data Integrity requirements? What does this mean to your Data Integrity Program? During this session, we will hear from a consultant and a U.S. FDA representative with their perspectives on what this means, how to apply them, and challenges you may face.

    8:30 a.m. – 9:00 a.m.
    Assuring Data Integrity in Drug Applications Submissions: Regulatory Expectation Challenges and Case Study
    Aditi S. Thakur, MS, Acting Quality Assessment Lead, Office of Pharmaceutical Quality, CDER, FDA

    9:00 a.m. – 9:30 a.m.
    The Tricky Transition from Development to Commercial Manufacturing: Compliance and Quality Risks
    Tom Cosgrove, JD, Partner, Covington & Burling LLP and formerly with the FDA

    9:30 a.m. – 10:00 a.m.
    Panel Discussion with Speakers and Additional Panelists
    Peter E. Baker, MS, Vice President, Green Mountain Quality Assurance and formerly with the FDA
    Els Poff,
    Executive Director, Data Integrity CoE, Merck & Co., Inc.
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA

    9:45 a.m. – 4:00 p.m.
    Exhibit Area Open

    10:00 a.m. – 10:30 a.m.
    Refreshment Break in Exhibit Area

    10:30 a.m. – 12:00 p.m.
    P4: Quality Culture: What is all the Buzz About?
    Moderator: Peter E. Baker, MS, Vice President, Green Mountain Quality Assurance

    Many of the new guidance and regulatory communications have specifically called out how important it is to have a good Quality Culture as the basis for Data Integrity. Join us for understanding why this is so important and how it is measured. In addition, a GlaxoSmithKline representative will present how they have effectively influenced their quality culture to support a robust Data Integrity Program. 

    10:30 a.m. – 11:00 a.m.
    Does Quality Culture Matter? A Data-Based Analysis
    Thomas Friedli, Director,  Institute of Technology Management, University of St. Gallen
    Julian Macuvele, MSc, Research Associate, University of St. Gallen

    11:00 a.m. – 11:30 a.m.
    Integrating Human Factors into our Data Integrity Strategy
    Ervin Rodriguez,
    Vice President, Quality Systems, Pharmaceutical Supply Chain, GlaxoSmithKline

    11:30 a.m. – 12:00 p.m.
    Panel Discussion with Speakers and Additional Panelists
    Cylia Chen-Ooi, MS, Director Quality External Affairs, Amgen Inc.
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA

    12:00 p.m. – 1:15 p.m.
    Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA Registration Desk.

    1:15 p.m. – 2:15 p.m.
    Concurrent Breakouts

    Breakout 1: Organizational Failure: Impact of Management and Employees Not Understanding Data Integrity Concepts
    Moderator: Ronald F. Tetzlaff, PhD, Corporate Vice President, PAREXEL International

    This session will explore examples of management failure to prevent and detect data integrity issues, how regulators are able to detect significant data integrity issues, and how to fix gaps.

    Speaker:
    David M. Churchward, MSc, Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), MHRA, UK

    Breakout 2: Utilizing Risk-Based Tools to Perform Smart Audit Trail Reviews in Manufacturing
    Moderator: Amanda Bishop McFarland, Senior Consultant, ValSource, LLC

    This session will explore how to identify what to review and at what frequency during Audit Trail Reviews of manufacturing equipment.

    Speaker:
    John Grealis, PhD, Regional Head Data Integrity, Novartis

    Breakout 3: Quality Culture: Milestones and Metrics in Support of Data Integrity
    Moderator: Kir Henrici, CEO, The Henrici Group

    This breakout will explore the insights, challenges, and big wins of a quality culture and data Integrity Initiative.

    Speakers:
    Ronald D. Gunn, MS, MBA,
    Chief Operating Officer, Kaleo, Inc.
    Gregory L. Tewalt, PhD, Director Quality and Compliance, Kaleo, Inc.

    2:15 p.m. – 2:30 p.m.
    Break 

    2:30 p.m. – 3:30 p.m.
    Group Discussion: Report Out
    Moderators: Jackie Veivia-Panter, Senior Director, Quality Systems and Compliance, Legend Biotech and Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA

    Learn from all of the case studies! Each breakout session will present a case, challenges identified, and possible solutions.

    3:30 p.m. – 4:00 p.m.
    Refreshment Break in Exhibit Area

    4:00 p.m. – 5:30 p.m.
    P5: Big Data Integrity
    Moderator: Kir Henrici,
    CEO, The Henrici Group

    This session invites data integrity futurists to explore the 21st century big data boom; taking a glimpse at technological innovations and intelligence trends and the ensuing paradox of challenges and rewards facing stewards of Data Integrity.  Participants will have the opportunity to exchange ideas during the Q&A following speaker presentations.

    4:00 p.m. – 4:30 p.m.
    Big Data: The Not-so-Basics
    Mark A. DiMartino, MS, Director Quality Data Sciences, Amgen

    4:30 p.m. – 5:00 p.m.
    Big Data Integrity
    Peter E. Baker, MS, Vice President, Green Mountain Quality Assurance and formerly with the FDA

    5:00 p.m. – 5:30 p.m.
    Panel Discussion with Speakers and Additional Panelist
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA

    5:30 p.m.
    Closing Remarks from Conference Co-Chair
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA











Highlighted Speakers

Peter E. Baker
Peter E. Baker
Green Mountain Quality Assurance and formerly with the FDA
David M. Churchward
David M. Churchward
MHRA, UK
Thomas C. Page
Thomas C. Page
FUJIFILM Diosynth Biotechnologies
Aditi S. Thakur
Aditi S. Thakur
FDA

Additional Information

  • Learning Objectives

    Learning Objectives

    At the completion of this event, attendees will be able to:

      • Describe the current regulatory climate and remediation expectations of data integrity
      • Define what is needed to engrain data integrity into the Quality Management System and Culture
      • Identify holistic challenges faced by the industry in data integrity
      • Discuss strategies on how to utilize quality risk management to prevent data integrity issues
      • Explain how to establish a quality culture which promotes data integrity as a core value
  • Who Should Attend

    Who Should Attend

    Job Functions

    GxP Business Process and System Owners | Compliance professionals | Batch Release and Qualified Persons | Quality Risk Managers | Automation Leads | Auditors | Trainers | Quality Control Professionals | Regulatory and Compliance Counsel
  • Accreditation

    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:

    0116-0000-19-026-L04-P | 0.95 CEUs
    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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Travel

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.

Renaissance Washington, DC Downtown Hotel

999 9th Street NW
Washington, DC

Make a Reservation
Renaissance Washington, DC Downtown Hotel
  • 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 Renaissance Washington, DC Downtown Hotel. The rate is $317 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, August 16, 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 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Renaissance Washington, DC Downtown Hotel at +1 (202) 898-9000. Please make sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    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 prior to the date of arrival by 6:00 p.m. (EST) to avoid cancellation fees.

  • Amenities

    The Renaissance Washington, DC Downtown Hotel is located in Penn Quarter; in the heart of downtown Washington DC. Local attractions include the National Portrait Gallery, Smithsonian Institute and Air Space Museum, Washington Monument, Capitol Hill, and many more. All 794 guest rooms and suites provide high-speed Internet, upgraded Luxurious bedding, coffee makers, hair dryers, iron, and an ironing board.

    Read more about the amenities offered at the Renaissance Washington, DC Downtown.

How to Get Here

By Air

Area Airports

Ronald Reagan Washington National (DCA) is approximately 5 miles away. Two other airports in the vicinity are both serviced by all major carriers: Dulles International (IAD) is 28 miles away and Baltimore/Washington (BWI) is 32 miles away.

By Car

Driving

Renaissance Washington, DC Downtown Hotel is located on 999 9th Street NW off of New York Avenue.

Hotel Parking

$35 / Daily Self-Parking
$45 / Daily Valet Parking

Other Options

Ground Transportation

Taxi fares from Reagan National are approximately $20 one way, not including tip, and will take about 20 minutes. One way taxi fares from Dulles is approximately $75 and from BWI is about $75.

Metro

Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National.

Train

Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at +1 (800) 872-7245 or visit www.amtrak.com.

Directions

Registration Fees

Early Registration
Registration Type Price by July 30
Member $1,495
Non-member $1,695
Young Professional Member † $748
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 July 30
Member $1,695
Non-member $1,895
Young Professional Member † $848
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.

Sponsors

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Featured Exhibitors

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Media Partners

Contact

Program Inquiries
  • Brooke Schneider, CMP
    Manager, Programs
    Tel: +1 (301) 656-5900 ext. 111
Exhibition Inquiries
Training Course Inquiries
  • Stephanie Ko
    Sr. Manager, Lecture Education
    Tel: +1 (301) 656-5900 ext. 151
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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