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Parenteral Drug Association Connecting People, Science and Regulation ®

Washington - 2016 PDA Data Integrity Workshop

Sep 14 - Sep 15, 2016 |
Sep 15, 2016 |
Renaissance Washington, DC Hotel | Washington, DC
  • Workshop
  • Western Hemisphere Events
Exhibition: September 14-15
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Data integrity has been and currently is a major global concern of Health Authorities and the pharmaceutical industry. Although not a new issue, numerous recent Health Authority enforcement actions (e.g., Warning Letters, Product Detentions) have brought increased attention to this subject.

Data integrity can result from lack of awareness, employee errors, failure to check accuracy of data, software or system malfunction, configuration problems with electronic data handling, or misconduct by employees. The challenges in the area of data integrity include but are not limited to, the increased reliance on electronic systems and complexity of supply chains. Companies must put in place a holistic, multi-faceted approach to address the underlying causes leading to data integrity risks and issues. To holistically address data integrity, PDA has planned a number of activities, including the 2016 Data Integrity Workshops, technical reports, Education courses, and the Elements of a Code of Conduct for Data Integrity, written for easy adoption by companies in the industry to address this serious issue.

The 2016 PDA Data Integrity Workshops will include a blend of presentations from regulatory and industry experts, case studies and round table discussions. Special focus on exploring the multiple facets of data integrity, such as quality culture, human behavior, training needs, and technology requirements, will help attendees get a broad perspective on common factors, and cause and effect. Through round table discussions, attendees will learn about best practices for preventing, detecting, mitigating and remediating data integrity issues. Ample opportunity will be provided for attendees to network with industry peers, regulators and solution providers to enhance the overall learning experience.

Learning Objectives

The main focus and aim of this Workshop is to understand the multiple facets of data integrity such as quality culture, human behavior, training needs, and technology requirements. In addition to promoting a holistic understanding of the challenges faced by the industry in this area, this event, will discuss strategies on how to tackle these (prevention, detection, response and learning). The the two-day Workshop agenda is comprised of interactive case studies, presentations and round table discussions.

Who Should Attend

  • GxP Business Process and System Owners
  • E-Compliance professionals
  • Batch Release and Qualified Persons
  • Quality Risk Managers
  • Automation Leads
  • Auditors
  • Quality Control  professionals
  • Regulatory  & Compliance Counsel

Contact

Workshop Inquiries

Wanda Neal, CMP
Sr. VP Programs and Registration Services
+1 (301) 656-5900 ext. 111
neal@pda.org

Melissa Pazornik
Manager, Programs & Meetings
+1(301) 656-5900 ext. 221
pazornik@pda.org

Registration Inquiries

+1 (301) 656-5900 ext. 115
registration@pda.org 

Exhibition Inquiries

David Hall
Vice President, Sales
+1 (301) 656-5900 ext. 160
hall@pda.org

Download Call for Papers

Submit Abstract

Wednesday, September 14, 2016

11:30 a.m. - 5:30 p.m.
Registration Open

1:00 p.m. – 1:10 p.m.
Welcome and Opening Remarks
Madlene Dole, Novartis,and Co-Chair, 2016 PDA Data Integrity Workshop Program Planning Committee

1:10 p.m. – 2:30 p.m.
P1 - Opening Plenary Session
Moderator: Madlene Dole, Novartis, andCo-Chair, 2016 PDA Data Integrity Workshop Program Planning Committee

1:10 p.m. – 1:30 p.m.
Regulatory Perspective: Guidance / Policy
Regulatory Representative Invited

1:30 p.m. – 1:50 p.m.
Introduction to Data Integrity & PDA Task Force Update
Anil Sawant, PhD, Vice President, Quality Management Systems & External Affairs, Merck

1:50 p.m. – 2:10 p.m.
Industry Perspective: Auditing & Case Study
Ronald Tetzlaff, PhD, Corporate Vice President, PAREXEL Consulting

2:10 p.m. – 2:30 p.m.
Questions and Answers/Discussion

2:30 p.m. – 7:15 p.m.
Exhibit Area Open

2:30 p.m. – 3:00 p.m.
Refreshment Break in Exhibit Area

3:00 p.m. – 4:15 p.m.
Breakout Working Groups
Breakout Working Group Instructions:
Each attendee will choose one of the breakout group sessions below. The facilitator will present a short case study which will be followed by group discussions and summary.

Breakout Group 1 - Manufacturing

Session Description:Data Integrity Incidents and Root Causes found throughout Industry

This session will cover a case study of a DI incident in a manufacturing setting. The case involves manipulation of computer settings and malfunction of equipment. The participants will use the case as a basis for discussion including root cause analysis, the impact of culture on DI, the role of leadership, impact assessment, and action planning.

Facilitator: Steven Lynn, Global Head, Group Compliance and Audit, Novartis Pharmaceutical Corporation

Breakout Group 2 - Analytics & Quality Control

Session Description: Data Integrity Event in Chemistry Laboratory. This session will cover a Case Study of a data integrity incident uncovered in a QC Chemistry Lab. The case will involve electronic data manipulation, actions of fellow chemists and employee dynamics, action and inaction by management, speak-up culture, independent investigation strategy, and identification of true root cause.

Facilitator: Anil Sawant, PhD, Vice President, Quality Management Systems & External Affairs, Merck

Breakout Group 3 – Clinical Data

Session Description: This session will cover a case study involving a data integrity incident at a clinical study investigator site. The case involves issues associated with subject eligibility and enrollment, data falsification, vendor performance and oversight and sponsor study management inaction. Discussion topics will include potential implications of the issues, appropriate actions to be taken as well as a discussion of root cause and preventative measures.

Facilitator: Leslie Sam, Director, Safety, Efficacy, Customer Information and Global Product Complaints, Global Quality Systems, Eli Lilly & Company

4:15 p.m. – 4:45 p.m.
Refreshment Break in Exhibit Area

4:45 p.m. – 6:00 p.m.
P2 – Roundtable Readout and Panel Discussion
Moderator: Zena Kaufman, Consultant, ZGK Quality Consulting

4:45 p.m. – 5:00 p.m.
Manufacuturing Case Study Readout
Steven Lynn, Global Head, Group Compliance and Audit, Novartis Pharmaceutical Corporation

5:00 p.m. – 5:15 p.m.
Analytics & Quality Control Case Study Readout
Anil Sawant, PhD, Vice President, Quality Management Systems & External Affairs, Merck

5:15 p.m. – 5:30 p.m.
Clinical Data Case Study Readout
Leslie Sam, Director, Safety, Efficacy, Customer Information and Global Product Complaints, Global Quality Systems, Eli Lilly & Company

5:30 p.m. – 6:00 p.m.
Panel Discussion

6:00 p.m. – 7:15 p.m.
Networking Reception in Exhibit Area

Thursday, September 15, 2016

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

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

8:30 a.m. - 10:00 a.m.
P3 – Day 2 Opening Plenary Session
Moderator: Ronald Tetzlaff, PhD, Corporate Vice President, PAREXEL Consulting

8:30 a.m. - 9:00 a.m.
General Concept of Data Integrity / Holistic Approach
Steven Lynn, Global Head, Group Compliance and Audit, Novartis Pharmaceutical

9:00 a.m. - 9:30 a.m.
Data Integrity: Local Implementation Considering Societal & Cultural Aspects
Industry Representative Invited

9:30 a.m. - 10:00 a.m.
Regulatory Inspection Observations
Regulatory Representative Invited

9:45 a.m. - 4:00 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.
Breakout Working Groups
Breakout Working Group Instructions:
Each attendee will choose one of the breakout group sessions below. The facilitator will present a short case study which will be followed by group discussions and summary.

Breakout Group 1 – Diagnosis & Detection

Session Description: Data Integrity Issues in a QC Chemistry Laboratory The session will focus on methods for detecting and diagnosing data integrity issues in a QC lab. This will include setting the scope and targeting high risk data, assessing controls, discovering the cultural and organizational impact, and conducting the forensic audit. Forensic auditing is a methodology utilized in this space and others that allows for the use of existing data to facilitate “where to look”. The session will include practical scenarios that will utilize the learned techniques.

Facilitator: Crystal Mersh, President & CEO, Quality Executive Partners

Breakout Group 2 - Remediation

Session Description: When firms are made aware of Data Integrity issues, it is important to develop comprehensive Remediate plans balancing what is achievable and sustainable with the need for swift and targeted solutions.  The speakers, who have firsthand knowledge with pragmatic solutions, will share their approaches.

Facilitator: Zena Kaufman, Consultant, ZGK Quality Consulting

Breakout Group 3 – Prevention

Session Description: Data Integrity Events in Clinical Trial Study Sites and Laboratories This session will cover a Case Study of data integrity incidents uncovered in Clinical Study sites and Laboratories conducted on sites located in two continents (Europe and Asia). The case will involve electronic data manipulation, paper documentation management, sponsor and CRO oversight, competence and availability of study site personnel, independent investigation strategy, and cultural aspects.

Facilitator: Ronald Tetzlaff, PhD, Corporate Vice President, PAREXEL Consulting

12:15 p.m. - 1:30 p.m.
Lunch

1:30 p.m. – 3:00 p.m.
Breakout Working Groups
Instructions:
Each attendee will choose one of the breakout group sessions below. The facilitator will present a short case study which will be followed by group discussions and summary.

Breakout Group 1 – Diagnosis & Detection (Continued)

Session Description: Data Integrity Issues in a QC Chemistry Laboratory The session will focus on methods for detecting and diagnosing data integrity issues in a QC lab. This will include setting the scope and targeting high risk data, assessing controls, discovering the cultural and organizational impact, and conducting the forensic audit. Forensic auditing is a methodology utilized in this space and others that allows for the use of existing data to facilitate “where to look”. The session will include practical scenarios that will utilize the learned techniques.

Facilitator: Crystal Mersh, President & CEO, Quality Executive Partners

Breakout Group 2 - Remediation (Continued)

Session Description: When firms are made aware of Data Integrity issues, it is important to develop comprehensive Remediate plans balancing what is achievable and sustainable with the need for swift and targeted solutions.  The speakers, who have firsthand knowledge with pragmatic solutions, will share their approaches.

Facilitator: Zena Kaufman, Consultant, ZGK Quality Consulting

Breakout Group 3 – Prevention (Continued)

Session Description: Data Integrity Events in Clinical Trial Study Sites and Laboratories This session will cover a Case Study of data integrity incidents uncovered in Clinical Study sites and Laboratories conducted on sites located in two continents (Europe and Asia). The case will involve electronic data manipulation, paper documentation management, sponsor and CRO oversight, competence and availability of study site personnel, independent investigation strategy, and cultural aspects.

Facilitator: Ronald Tetzlaff, PhD, Corporate Vice President, PAREXEL Consulting

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

3:45 p.m. – 5:00 p.m.
P4 – Readout and Panel Discussion
Moderator: Anil Sawant, PhD, Vice President, Quality Management Systems & External Affairs, Merck, and Co-Chair, 2016 PDA Data Integrity Workshop Program Planning Committee

3:45 p.m. – 4:00 p.m.
Diagnosis & Detection Readout
Crystal Mersh, President & CEO, Quality Executive Partners

4:00 p.m. - 4:15 p.m.
Remediation Readout
Zena Kaufman, Consultant, ZGK Quality Consulting

4:15 p.m. – 4:30 p.m.
Prevention Readout
Ronald Tetzlaff, PhD, Corporate Vice President, PAREXEL Consulting

4:30 p.m. – 5:00 p.m.
Panel Discussion

5:00 p.m.
Closing Remarks and Adjournment
Anil Sawant, PhD, Vice President, Quality Management Systems & External Affairs, Merck

Conference and Workshop Registration | September 12-15, 2016

Member

Before July 1, 2016
$3,740

July 1- August 2, 2016
$4,190

After August 2, 2016
$4,640

Nonmember

Before July 1, 2016
$4,199

July 1- August 2, 2016
$4,646

After August 2, 2016
$5,099


Workshop Registration | September 14-15, 2016

Member

Before August 2, 2016
$1,495

After August 2, 2016
$1,695

Nonmember

Before August 2, 2016
$1,695

After August 2, 2016
$1,895


Government/Health Authority/Academic

Member

Before and after August 2, 2016
$700

Nonmember*

Before and after August 2, 2016
$800


Student

Member

Before and after August 2, 2016
$280

Nonmember*

Before and after August 2, 2016
$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 workshop and course.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Workshop 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 assist you with. 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 cancellation notice is not received by July 14, 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 nonmember substituting for a member, you will be required to pay the difference nonmember 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 Full Conference, Workshops and Events: If your written request in received on or before July 14, 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. Tape recordings are prohibited at all PDA conferences.

Renaissance Washington, DC Hotel
999 9th Street NW
Washington, DC 20001
Phone: +1 (202) 898-9000

Rate: Single: $305.00, plus applicable taxes (14.5%).

Cut Off Date: Thursday, August 11, 2016 (Availability may be limited. Requests will be processed on a first-come, first-served basis. Attendees staying within the PDA block will receive the conference rate.

Hotel Accommodations

To make reservations at the Renaissance Washington, DC Hotel, please call the Hotel at +1 (202) 898-9000 and reference the 2016 PDA/FDA Joint Regulatory Conference, 2016 Data Integrity Workshop & PDA Education to receive the PDA group rate. Check in time is 4:00 p.m., and check out time is 12:00 noon.

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 6 p.m. on the date of arrival otherwise specified on your reservation information.

Amenities

The Renaissance Washington, DC 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.

Travel

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.

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 http://www.amtrak.com.

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

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

The 2016 PDA Data Integrity Workshop offers exciting and unique sponsorship and exhibit packages designed to strengthen brand image, increase visibility and help you connect with industry leaders in this dynamic field. This Workshop will bring together GxP business process and system owners, e-compliance professionals, batch release and qualified persons, quality risk managers, automation leads, auditors, quality control professionals, and regulatory and compliance professionals.

The Workshop schedule provides ample time to network with qualified attendees from a variety of manufacturing companies – making this a must-attend meeting. In addition, high-profile sponsorship packages are available for lanyards, notepads, tote bags, pens, refreshment breaks, lunch and the networking reception. We'll create a customized package to fit your needs and budget.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall
Vice President, Sales
Direct: +1 (301) 760-7373 Cell: +1 (240) 688-4405 E-mail: hall@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=2762

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