4th ann ual data integrity validation · 9:15 analyze mhra’s new gxp data integrity guidance the...
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REGISTER AT WWW.CBINET.COM/DATAINTEGRITY • 800-817-8601
A division ofUBM Americas
R E G I S T E R BY J U N E 8 , 2 0 1 8 A N D S AV E $ 3 0 0 !
Bryan Blank, Principal & Chief Information Officer, Sharp Point Security Solutions, LLC
Steven Brown, BSE, MBA, CSSBB, Senior Manager, Systems and Technology Management, Celgene Corporation
Felicia Ford-Rice, Director, PAREXEL International
Calvin Kim, Senior GXP IT Auditor, Bayer
Heather Longden, Senior Marketing Manager, Informatics and Regulatory Compliance, Waters Corporation
Orlando López, E-Compliance and E-Records Integrity, SME
Ryan Ott, Managing Partner, Azzur Group, LLC
Matthew Paquette, Product Specialist, Charles River
Chinmoy Roy, Senior Systems Application Engineer, Genentech (retired), Independent Consultant
J Loren Smith, Senior Manager, Global Compliance & Ethics, Computer Systems/Data Integrity, BioMarin Pharmaceutical, Inc.
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
Teri Stokes, Director, Quality Assurance Compliance, Cytel
Robert Wherry, MSc MS CPGP CQA CPIP, Head, R&D Data Systems, Quality Assurance and Compliance, Shire plc
Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
INDUSTRY’S LEADING SUBJECT MATTER EXPERTS:
Data Integrity Validation
AUGUST 15-16, 2018 • COURTYARD BOSTON CAMBRIDGE • BOSTON, MA
Overcome Roadblocks, Identify Solutions and Implement Processes for a Successful Data Governance Program
4th Annual
TOP THREE REASONS TO ATTEND
1 Gain an In-Depth Analysis of MHRA’s Final Guidance on GXP Data Integrity
2 Learn How to Build a Culture of Data Integrity Through a Comprehensive Data Governance Program
3 Education Across GXP — Detect Data Integrity Lapses in the Laboratory, Manufacturing and Clinical Environments
Choose Between Two Customized Workshops Based on Experience Level:
INTERMEDIATE: Implement a Data Governance Plan that Suits Your Organization’s Processes
ADVANCED: Utilize the GAMP Data Integrity Maturity Model to Assess Your Effectiveness
REGISTER AT WWW.CBINET.COM/DATAINTEGRITY • 800-817-8601
Premier Media Partners: Supporting Media Partners:
DAY ONE WEDNESDAY, AUGUST 15, 20187:30 Conference Check-In and Continental Breakfast
8:15 Conference Chairman’s Welcome and Opening Remarks
8:30 Data Integrity Around the World — Evaluate the Trends from Global Regulatory Standards
9:15 Analyze MHRA’s New GXP Data Integrity Guidance
10:00 Networking and Refreshment Break and Office Hours
10:30 “Homo Sapiens atque Integritas Notitia” (Human Beings and Data Integrity)
11:15 Pilot Implementation — How Moving to a Paperless Solution Achieves Process Improvements
12:00 Networking Luncheon
1:00 Eliminate Risk and Human Error in Manufacturing and Laboratory Processes
1:45 CHOOSE BETWEEN TWO IN-CONFERENCE WORKSHOPS (A-B)
Workshop B ADVANCED Utilize the GAMP Data Integrity Maturity Model to Assess Your Effectiveness
Workshop A INTERMEDIATE Implement a Data Governance Plan that Suits Your Organization’s Processes
*There will be a 30-minute networking and refreshment break at 3:15pm
5:15 Close of Day One | Networking Reception hosted by:
ALIDATION WEEK24TH ANNUAL
&
DAY TWO THURSDAY, AUGUST 16, 20187:30 Continental Breakfast and Office Hours
8:00 Conference Chairman’s Review of Day One
8:15 Innovations in the Cloud — Simplifying the Quality Systems Validation Process
9:00 Implement Cyber Security Best Practices to Support IT Data Governance Programs
9:45 Networking and Refreshment Break and Office Hours
10:15 CHOOSE FROM TWO 90-MINUTE SESSIONS (1-2)
Session 2 GCP FOCUS Navigate Data Integrity Expectations in the GCP Environment
Session 1 GMP FOCUS Interpret FDA and MHRA Guidelines from a Manufacturing Mindset
11:45 Networking Luncheon
12:45 CHOOSE FROM TWO 90-MINUTE SESSIONS (3-4)
Session 4 GMP FOCUS Apply Data Governance to Manufacturing Systems and Process Automation
Session 3 GMP & GCP FOCUSIt’s Elementary! Detecting Data Integrity Lapses in the Laboratory, Manufacturing and Clinical Environments
2:15 Networking and Refreshment Break and Office Hours
2:45 INSPECTION READINESS CRASH COURSE How Not to Crash and Burn During Your Next Agency Inspection
4:15 PANEL DISCUSSION Ask the Experts — Open Audience Q&A to Discuss Core Data Integrity Concepts and Challenges
5:00 Chairman’s Closing Remarks and Close of Conference
Foyer
Ballroom A
Ballroom B
Ballroom A
Ballroom A
Ballroom A Riverview
Bistro
Ballroom B
Ballroom B
Ballroom A
Ballroom A Riverview
Ballroom A Riverview
Ballroom B
Ballroom A
Bistro
REGISTER AT WWW.CBINET.COM/DATAINTEGRITY • 800-817-8601
DAY ONE WEDNESDAY, AUGUST 15, 20187:30 Conference Check-In and Continental Breakfast
8:15 Conference Chairman’s Welcome and Opening Remarks Robert Wherry, MSc MS CPGP CQA CPIP, Head, R&D Data Systems, Quality Assurance and Compliance, Shire plc
8:30 Data Integrity Around the World — Evaluate the Trends from Global Regulatory StandardsWith eight health agency data integrity-related published guidance documents, this session provides a practical look at the correlation, evaluation and trends between them. This session focuses on electronic records integrity. • Key elements of each guidance document• Consistencies between guidance documents• Differences between guidance documents• Trends between guidance documentsOrlando López, E-Compliance and E-Records Integrity, SME
9:15 Analyze MHRA’s New GXP Data Integrity Guidance The MHRA have led the way for clarifying guidance in the area of data integrity, first addressing the needs of GMP/GDP regulated data and now harmonizing the language to apply easily to GLP and GCP arenas. The UK agency has also worked closely with the PIC/s organization in recent years, so we expect to see traces of the MHRA guidance document in the upcoming PIC/s revision. In this session, attendees hear about the updated language and new sections of the industry-reviewed guidance and have an opportunity to share their views of its success.• New definitions for data collection, data processing,
data transfer and data migration as well as detailed examination of the creation of “true copies”
• Promotion of a risk-based data review approach, including the use of exception-focused review of data, audit trails and the role of periodic data review
• Clarification of data backup and practical approaches to data archive
• Understand the roles and responsibilities of IT suppliers, especially cloud hosting service providers
Heather Longden, Senior Marketing Manager, Informatics and Regulatory Compliance, Waters Corporation
Office Hours — Meet one-on-one with speakers to solve your individual data integrity challenges
10:00 Networking & Refreshment Break
10:30 “Homo Sapiens atque Integritas Notitia” (Human Beings and Data Integrity)You might have noticed that modern pharmaceutical and medical device companies are infested with human beings. Brit Marling says that, “[h]uman beings are flawed and complicated and messy.” In this session, we start a discussion on the various aspects (and academic disciplines) of human behavior that can and do impact data integrity within your organization, through the combined lenses of psycho-/socio-/anthropo-logy and economics. We also discuss how you can use a rudimentary understanding of these disciplines to
increase the inherent integrity of your organization and the data it generates.• Detection
* how to recognize fraud and human error, and how to tell the difference
* how to understand more of what your data is trying to tell you
• Prevention* thinking about how people are really incentivized
and managed in your organization, and the potential resultant behaviors
* the power of belief, humility and norms to increase data integrity
* concepts of organizational maturity as they apply to data integrity
J Loren Smith, Senior Manager, Global Compliance & Ethics, Computer Systems/Data Integrity, BioMarin Pharmaceutical, Inc.
11:15 Pilot Implementation – How Moving to a Paperless Solution Achieves Process ImprovementsThis session provides a practical look at the implementation of a ValGenesis system and how it improves processes.• Gain real-time visibility• Understand data integrity benefits• Improve good documentation practices• Achieve 100% paperless validation lifecycle process• Prepare for audit readinessLizzandra Rivera, Associate Director, IT Quality, Alexion PharmaceuticalsSteve Thompson, Senior Manager, Professional Services, ValGenesis, Inc.
12:00 Networking Luncheon
1:00 Eliminate Risk and Human Error in Manufacturing and Laboratory Processes The human element can never be completely eliminated, but it’s important to understand what can be done to mitigate the risk for human error and how it relates to data integrity. There are two main pillars that link data integrity compliance to our industry: 1) software and electronic data compliance and 2) risk mitigation strategies for human error. Reducing the risk for human error in our manufacturing and laboratory processes ensure that we comply with data integrity laws and regulations while building quality into everyday processes and thus keeping patients and drugs safe. As laboratory testing shifts from observation-based qualitative methods to more objective quantitative methods, a focus on data integrity becomes more critical to ensure overall product quality and patient safety. • Utilize an organized, risk-based approach to
close human error gaps in processes to prove to all stakeholders that the data used to determine product quality is integral and accurate
• Examine real-world examples from the industry to allow for the evaluation of processes for unnecessary data integrity and human error risks
• Reduce a laboratory’s risk to human error and data integrity violations in the future through implementing automation
Matthew Paquette, Product Specialist, Charles River
REGISTER AT WWW.CBINET.COM/DATAINTEGRITY • 800-817-8601
1:45 C H O O S E B E T W E E N T W O I N - C O N F E R E N C E W O R K S H O P S (A - B )
INTERMEDIATE Implement a Data Governance Plan that Suits
Your Organization’s Processes
ADVANCED Utilize the GAMP Data Integrity Maturity Model
to Assess Your Effectiveness I. Overview of the GAMP
Guide on Electronic Records and Data Integrity• Review key points of the guide,
including:* governance* data lifecycle* risk management* data integrity programs
II. Review the Data Integrity Maturity Model• Understand the guidelines
provided by the model • Learn to apply the model to your
data governance program
III. Conducting the Self-Assessment • Preparation• Roles and responsibilities• Mitigation• Follow-up
IV. Interactive Exercise Attendees break into teams to develop a plan for conducting data integrity self-assessments against the GAMP data integrity maturity model.
BONUS MATERIAL • A consolidated plan, developed
by the various teams, is collated and provided to attendees
Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
Calvin Kim, Senior GXP IT Auditor, Bayer
B
A
I. Understand Regulatory Requirements for Data Integrity (DI)• What is DI and what are its
principles?• Find out why data integrity is not a
new regulatory requirement• Compendial 21 CFR Part 11
requirements• Learn why Part 11 requirements
are not the same as data integrity requirements
II. Explore Data Integrity Guidances from Different Regulatory Agencies• Review data integrity guidances
from regulatory agencies, including FDA, MHRA and WHO
• Understand the distinctions and similarities between the DI guidances
• Learn which DI guidances are meant for legacy systems
III. Learn How to Use “The Least Burdensome Approach” to Develop Your DI Plan • Understand the “Least
Burdensome Approach” and the benefits of its use to develop a DI plan
• Discover regulations that support the “Least Burdensome Approach”
• Examine Warning Letter trends that support a “Least Burdensome Approach” for a DI plan
• Learn how to use the DI guidances to validate your DI plan
• Summarize the steps to develop your DI plan
IV. Develop a Data Integrity Management System • Analyze deviant human behaviors
and the data manipulation triangle• Gain familiarity with the data
integrity controls triad
• Understand the essentials of the 5-p model of data integrity
• Learn how to use the 5-p model to bullet proof your data integrity audits by regulators
V. Interactive Exercise Attendees should bring a list of general data integrity implementation challenges that they are encountering in their respective companies. The workshop opens with participants breaking up into smaller work groups to discuss the challenges. The workshop concludes with participants breaking up into their original groups to apply the lessons learned from the workshop to develop a DI plan that they take back to work.
BONUS MATERIAL • A template SOP for “Performing
An Audit Trail Review”
Chinmoy Roy, Senior Systems Application Engineer, Genentech (retired), Independent Consultant
5:15 Close of Day One
NETWORKING RECEPTION HOSTED BY:
ALIDATION WEEK24TH ANNUAL
OCTOBER 22-24, 2018 • CORONADO ISLAND MARRIOTT • SAN DIEGO, CA
immediately following the final session on day one
There will be a networking and refreshment break at 3:15pm
I. What Is Data Integrity? • ALCOA+• The data lifecycle• What auditors are seeing — Real-life examples
II. FDA Regulations and Guidances• 21 CFR Part 11 (1997)• Data Integrity Compliance with cGMP for Industry (2016)• Part 11, Electronic Records; Electronic Signatures —
Scope and Application (2003)
III. MHRA• Guidance on GXP Data Integrity (2018)
IV. Regulations and Guidance Related to Data Integrity for Computerized Systems• European Commission Annex 11 — Computerised
Systems (2011)
V. From Paper to Electronic• Ensuring data integrity during data migration activities
VI. How Do We Ensure the Integrity of Our Electronic Data in Validated Computerized Systems?• Dynamic vs. static data• User access control• Role-based security• Physical security• Backup, restore and disaster recovery• Data retention• Date and time stamps• Printouts vs. electronic copies• Audit trails• Electronic signaturesRaul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
REGISTER AT WWW.CBINET.COM/DATAINTEGRITY • 800-817-8601
10:15 CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (1-2)
GMP FOCUS Interpret FDA and MHRA Guidelines From a Manufacturing Mindset1
DAY TWO THURSDAY, AUGUST 16, 2018
Office Hours — Meet one-on-one with speakers to solve your individual data integrity challenges
7:30 Continental Breakfast
8:00 Conference Chairman’s Review of Day OneRobert Wherry, MSc MS CPGP CQA CPIP, Head, R&D Data Systems, Quality Assurance and Compliance, Shire plc
8:15 Innovations in the Cloud — Simplifying the Quality Systems Validation ProcessLife science companies operating under GxP regulations must perform validation in order to be compliant. They must demonstrate that their manufacturing processes will produce products that ensure regulatory compliance with cGMP principles, and make certain products deliver the expected results and do not harm the consumer. This session discusses:• Adhering to FDA requirements• QMS approach to validation• Elements of a risk-based validation plan• Possible challenges and risks• Future of cloud validation
Bruce Kratz, Chief Technology Officer, Sparta Systems
9:00 Implement Cyber Security Best Practices to Support IT Data Governance ProgramsWith cyber security becoming a growing concern across many industries, the life sciences industry must be prepared for securing electronic and cloud-based data. This session presents an overview of potential cyber threats, strategies life sciences companies can employ to prepare for cyber breaches and analyzes examples of cyber qualification and validation best practices.• Consider cyber security issues in validation processes• Determine how cyber qualification can be integrated
into a data governance program• Implement personnel training for cyber safety• Understand the potential cyber risks and data
integrity lapses that can occur with inadequate cyber qualification
BONUS MATERIAL• Example checklist for cyber security
best practices
Bryan Blank, Principal & Chief Information Officer, Sharp Point Security Solutions, LLC
Ryan Ott, Managing Partner, Azzur Group, LLC
Office Hours — Meet one-on-one with speakers to solve your individual data integrity challenges
9:45 Networking & Refreshment Break
I. Overview of the GCP Data Integrity Requirements • Application of data integrity principles to GCP• Review applicable regulatory guidance
II. e-Clinical Systems and Examples• Review different types of e-Clinical systems• Analyze examples of issues that may occur
III. Conduct GCP Data Integrity Assessments• Establish a process to conduct GCP data
integrity assessments• Review examplesChris Wubbolt, Principal Consultant, QACV Consulting, LLC
GCP FOCUS Navigate Data Integrity Expectations in the GCP Environment 2
11:45 NETWORKING LUNCHEON
REGISTER AT WWW.CBINET.COM/DATAINTEGRITY • 800-817-8601
Data integrity, while not a new regulatory requirement, has been a hot topic for the past several years and is highly publicized in numerous regulatory authority inspections conducted in multiple countries. Initially, data integrity lapses seemed to be focused on pharmaceutical laboratories, subject to good manufacturing practices. However, data integrity lapses have also manifested in manufacturing operations as well as in clinical environments.
I. You Keep Using That Word, I Do Not Think It Means What You Think It Means! • Explore data integrity concepts
II. New Rules• Current guidance documents from regulatory
authorities and non-governmental entities
III. Can You See What I See? • A brief review of GXP regulatory authority inspection
observations both old and new
IV. Which One of These Things Is Not Like the Other? • A summary of case studies that compares and
contrasts how data integrity lapses occur across laboratory, manufacturing and clinical environments
V. Let’s Play! Interactive ExerciseParticipants assess GMP laboratory, manufacturing operations and clinical environment data integrity lapses through a game of DI Jeopardy.
BONUS MATERIAL• Tabulation of current data integrity guidelines
by GXP content, data integrity assessment template for GMP laboratory, manufacturing environment and clinical environment
Felicia Ford-Rice, Director, PAREXEL International
12:45 CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (3-4)
GMP & GCP FOCUSIt’s Elementary! Detecting Data Integrity Lapses in the Laboratory,
Manufacturing and Clinical Environments3
I. Manufacturing Technology Overview• Understand technology layers and system architecture• Define the major features of process automation and
manufacturing systems
II. Components of Data Governance• Regulations, guidelines and the QMS• Technology controls• Organizational culture
III. Assess Legacy Systems• Organize the effort• Develop assessment boundaries• Establish an assessment methodology• Execution, gap identification and remediation• Information management• Incorporation into routine operations
IV. Interactive Exercise — Assess Legacy SystemsParticipants break up into several teams and discuss the sort of systems they work with. Select an example system and develop a brief sketch of the system
architecture to share with the rest of the class. Then, create a high process map to illustrate how the system is used within the business process. Translate this information to a data map to show the data lifecycle and perform a cursory data integrity assessment. Finally, identify schemes of remediating gaps, managing assessment information and incorporating system governance requirements into routine operations.
V. Building Data Integrity Into Systems• Perform early lifecycle assessments• Validation practices• System management practices
BONUS MATERIAL • System assessment examples and templates
Steven Brown, BSE, MBA, CSSBB, Senior Manager, Systems and Technology Management, Celgene Corporation
GMP FOCUS Apply Data Governance to Manufacturing Systems
and Process Automation 4
Office Hours — Meet one-on-one with speakers to solve your individual data integrity challenges
2:15 Networking & Refreshment Break
REGISTER AT WWW.CBINET.COM/DATAINTEGRITY • 800-817-8601
A GREAT PLACE TO MEET YOUR MARKETTake advantage of the best opportunity to meet potential clients face-to-face. Build relationships
while demonstrating thought leadership and sharing expertise. For more information on how to position your company as a sponsor or exhibitor, contact Hunter Gates at 339-298-2108 or [email protected].
CONFERENCE SPONSORS INCLUDE:
5:00 CHAIRMAN’S CLOSING REMARKS AND CLOSE OF CONFERENCE
2:45 INSPECTION READINESS CRASH COURSE How Not to Crash and Burn During Your Next Agency Inspection
I Walking a Mile in the Shoes of the Agency Auditor• Responsibilities of the agencies• Agency assumptions — The paradigm• Transparency — What it sometimes appears to be and what it is not• What would an auditor like to do and see?• Characteristics of a trustworthy auditee
II. You Still Haven’t Found What They’re Looking For…• Roles and responsibilities during inspections• Reverse engineering preparedness• Agency requests — Anticipation, interpretation and clarification• Sorry seems to be the hardest word — Admission of known pre-audit errors
III. Inspectional Observations and Responses• Mama Mia Culpa — Admission of audit-discovered errors and clarifying misperceptions• Band-Aids, therapy or surgery — Are you fixing the problem or not?
IV. Interactive ExerciseWorking through some potential data integrity issues, discuss how to prepare for those issues from an inspection readiness perspective.
BONUS MATERIAL• Data Integrity Risk Assessment (DIRA) template• Periodic Review Template
Robert Wherry, MSc MS CPGP CQA CPIP, Head, R&D Data Systems, Quality Assurance and Compliance, Shire plc
4:15 PANEL DISCUSSION Ask the Experts — Open Audience Q&A to Discuss Core Data Integrity Concepts and Challenges In this audience-driven Q&A session, a panel of industry experts gather to respond to live questions from the audience and share strategies that have proven successful.• Learn from experts on top challenges regarding data integrity • Engage in dynamic dialogue to discuss expected regulatory actions• Hear lessons learned and best practices for managing a positive data integrity program• Understand the relationship between data privacy, data integrity and data accuracy MODERATOR: Robert Wherry, MSc MS CPGP CQA CPIP, Head, R&D Data Systems, Quality Assurance and Compliance, Shire plc PANELISTS: Steven Brown, BSE, MBA, CSSBB, Senior Manager, Systems and Technology Management, Celgene Corporation Felicia Ford-Rice, RAC, Director, Compliance and Regulatory Strategy, PAREXEL InternationalTeri Stokes, Director, Quality Assurance Compliance, Cytel Chinmoy Roy, Senior Systems Application Engineer, Genentech (retired), Independent Consultant Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
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Wednesday, August 15, 20181:30 - 5:00 A B
Thursday, August 16, 201810:15 - 11:45 1 2
12:45 - 2:15 3 4
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Data Integrity Validation
AUGUST 15-16, 2018 • COURTYARD BOSTON CAMBRIDGE • BOSTON, MA
Overcome Roadblocks, Identify Solutions and Implement Processes for a Successful Data Governance Program
4th Annual
A division ofUBM Americas
R E G I S T E R BY J U N E 8 , 2 0 1 8 A N D S AV E $ 3 0 0 !
ANY QUESTIONS OR TO REGISTER CONTACT:
Michael Berube phone 339-298-2185
email [email protected]