ubm americas data integrity validation · data integrity validation august 16-17, 2017 • westin...

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 1 6 , 2 0 1 7 A N D S AV E $ 3 0 0 !

Data Integrity Validation

AU G U S T 1 6 - 1 7 , 2 0 1 7 • W E S T I N S A N D I E G O • S A N D I E G O, CA

Build Proactive Strategies for the Prevention and Remediation of Data Integrity Non-Compliance

3rd Annual

• Bradford Allen, Global GMP Computer Systems Quality, Genentech

• Bob Buhlmann, Director Corporate Quality Assurance, Amgen, Inc.

• Ed Eirikis, Computer Validation & Compliance Manager, Janssen BioTherapeutics

• Kim Lim, CEO, Ultimate Labs Inc.

• Lizzandra Rivera, Senior Manager, IT Quality, Alexion Pharmaceuticals

Cathlin Shapiro, MBA, CISA, Associate Director, eSystems Compliance and Quality Programs, Global Quality, Bristol-Myers Squibb

Paul Smith, Global Strategic Compliance Manager, Agilent Technologies

• Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems

• James P. Stumpff, RPh, Principal Consultant, PAREXEL International, Former Supervisory Investigator, FDA

• Chris Wubbolt, Principal Consultant, QACV Consulting, LLC

A U G U S T 1 6 - 1 7 , 2 0 1 7 • W E S T I N S A N D I E G O • S A N D I E G O , CA

INDUSTRY THOUGHT LEADERS:

KEY TOPICS INCLUDING:

Continual Gap Analysis

ALCOA+ Principles

Design Controls

Risk-Based Approaches

Regulatory Update

Laboratory Assessments

Inspection Preparation

Robust CAPA

Audit Trail Monitoring


FEATUREDS E S S I O N

Mock Audit 360° — Applying Data Integrity Learnings from Health Authority Inspections Presented by: BioMarin Pharmaceutical Inc.

http://www.cbinet.com/dataintegrity

http://www.ivtnetwork.com


DAY ONE WEDNESDAY, AUGUST 16, 20177:30 Conference Registration and Continental Breakfast

8:15 Chairman’s Welcome and Opening Remarks

8:30 IN-CONFERENCE WORKSHOP Implement Risk-Based Approaches for Data Integrity *There will be a Networking and Refreshment Break at 10:00

12:00 Networking Luncheon

1:15 Data Integrity — A Brief History and Regulatory Update

2:15 Leverage ALCOA+ Principles and Beyond for Assurance of Data Integrity

3:15 Networking and Refreshment Break

3:45 Utilize Efficient Audit Trail Monitoring as a Part of Data Quality Review Processes

4:45 Cultivate Robust CAPA for Common Data Integrity Non-Compliance

5:45 Close of Day One | Cocktail Reception hosted by:

DAY TWO THURSDAY, AUGUST 17, 20177:30 Continental Breakfast

7:45 CHOOSE BETWEEN TWO EYE-OPENER BREAKFAST DISCUSSIONS (A-B)

Perform Laboratory Assessments for Data Integrity Compliance

A Practical Approach to Performing Data Integrity Gap Analysis for Laboratory

8:30 CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (1-2)



SESSION 3 Configuring Software for Data Integrity

SESSION 4 Translate Strategy into Action in Procedures and Effectively Create SOPs



SESSION 6 Utilize Forensic Methodology to Determine the Root Cause of a Data Integrity Issue

SESSION 5 The How To’s and How Not To’s — A Case Study of Data Integrity Governance Implementation

2:45 Networking Refreshment Break

3:00Mock Audit 360° — Applying Data Integrity Learnings from Health Authority Inspections

4:30 Close of Conference

ALIDATION WEEK23RD ANNUAL

OCTOBER 17-19, 2017 • DOUBLE TREE BY HILTON • PHILADELPHIA, PA

A. B.

Premier Media Partners: Supporting Media Partner:

SESSION 1 Discuss Key Data Integrity Challenges and Brainstorm Solutions

Senior-Level Think

Tank

SESSION 2 Incorporate Design Controls for Data Integrity in a Paperless World



1:15 Data Integrity — A Brief History and Regulatory UpdateIn this session, learn about historical events that led to regulatory changes and how these same events continue to occur today. Discuss the recent industry guidance documents and current regulatory trends to facilitate learning from the many mistakes of the past.

• Brief history of data integrity

• Regulatory changes resulting from historical data integrity events

• Current guidance documents from health authorities and industry organizations

• Current regulatory trends

Bonus Material:• “Data Integrity Déjà Vu”, an article co-authored

by Mr. Stumpff

James P. Stumpff, RPh, Principal Consultant, PAREXEL International, Former Supervisory Investigator, FDA

2:15 Leverage ALCOA+ Principles and Beyond for Assurance of Data IntegrityTraditional validation using the CSV lifecycle approach is not sufficient to ensure data integrity. In this session, learn how to implement a data lifecycle approach to validation that emphasizes ALCOA+ data integrity concepts to ensure systems are validated for their intended use.

Attendees gain an in-depth look at the practical implementation of the data lifecycle.

• Review of ALCOA+ principles

• Gain an understanding of the data lifecycle

• Apply ALCOA+ to data integrity core principles

• Use ALCOA+ to validate with respect to data integrity

Bradford Allen, Global GMP Computer Systems Quality, Genentech


3:45 Utilize Efficient Audit Trail Monitoring as a Part of Data Quality Review ProcessesDo you understand audit trail requirements and how to implement them with practical quality? Participate in a discussion about audit trails and the objectives you are trying to achieve with monitoring data..

• What do the regulators expect?

• Audit trail required features

• Audit trail capture of Reasons (Why? or Why Not?)

• What extra information do audit trails provide over simple data review?

• Leveraging error messages/codes to troubleshoot data or audit trail anomalies

• Designing Data Review processes that include audit trails where appropriate.

• Everyday Review vs Periodic Review

• Documenting Data Review (including audit trails)

Heather Longden, Informatics and Regulatory Compliance Marketing Manager, Waters Corporation


7:30 Conference Registration and Continental Breakfast 8:15 Chairman’s Welcome and Opening Remarks

James Waterbury, MBA, Associate Director, Computer Systems/Data Integrity, Global Compliance and Ethics, BioMarin Pharmaceutical Inc.

8:30–12:00 I N - C O N F E R E N C E W O R K S H O P

Implement Risk-Based Approaches for Data Integrity

DAY ONE WEDNESDAY, AUGUST 16, 2017

I. Understand Requirements for Data Integrity • Regulatory requirements for

data integrity • Industry guidance requirements • Inspectional observations

II. How to Develop a Data Integrity Program• Define the elements for a data

integrity program• Identify risk factors of

data integrity• Evaluate techniques for detecting

data integrity issues • Defining controls to minimize data

integrity issues

III. Include Data Integrity with Your Contractors • Understand who should be

included based on risk• Learn about approaches to assess

the contractors• Implement and document

the assessment

IV. On-Going Monitoring, Evaluation and Governance • Understand what should be

monitored on an on-going basis• Learn techniques for identifying

data integrity issues • Learn techniques for developing a

data mapping process

V. Interactive Exercise During this session, participants use the principles from the class to identify types of data integrity issues from several examples provided and where they should monitor the types of controls that should be implemented.

Bob Buhlmann, Director Corporate Quality Assurance, Amgen, Inc.

Steven Brown, Senior Manager, Systems and Technology Management, Celgene Corporation

There will be a networking and refreshment break at 10:00am



4:45 Cultivate Robust CAPA for Common Data Integrity Non-Compliance What does data integrity mean to the industry? In this session, learn how data integrity has an impact on the regulated industry and which requirements are applicable to maintain data integrity.

• Address data integrity shortfalls and challenges and learn how to identify them

• Determine which deliverables are needed to correct data integrity issues

• Effective use of CAPAs for corrective data integrity shortfalls

• Overcome challenges during the creation, management and closure of data integrity CAPAs

• Discuss the benefits of implementing effective data integrity CAPAs

Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems

5:45 Close of Day One

COCKTAIL RECEPTION HOSTED BY:

ALIDATION WEEK23RD ANNUAL

OCTOBER 17-19, 2017 • DOUBLE TREE BY HILTON • PHILADELPHIA, PA

immediately following the final session on day one

7:45 CHOOSE BETWEEN TWO EYE -OPENER BREAKFAST DISCUSSIONS (A-B)


7:30 CONTINENTAL BREAKFAST

I. Identification of Existing (Hybrid or Paper-Based) Processes• Identify the compliance and

process gaps

• Identify the challenges of using electronic systems

• Detect opportunities to control for gaps in compliance

II. Scrutinize Existing or Potential Electronic Systems • Find process gaps

• Discover compliance gaps

• Implement technical controls

• Implement procedural controls

• Discuss ways to automate processes rather than rely on human intervention

III. Interactive ExerciseParticipants list electronic and paper-based (if hybrid) systems then review processes from beginning to end (i.e., sample receipt through final data report). Participants discuss or brainstorm on ways to seal these gaps.

Bonus Material:• Examples of electronic systems

and their configurations• Examples of controls we have

put in place for our electronic systems

Ed Eirikis, Computer Validation & Compliance Manager, Janssen BioTherapeutics

DAY TWO THURSDAY, AUGUST 17, 2017

Incorporate Design Controls for Data Integrity in a Paperless World

A. A Practical Approach to Performing Data Integrity Gap Analysis for Laboratory

Paul Smith, Global Strategic Compliance Specialist, Agilent Technologies

B. Perform Laboratory Assessments for Data Integrity ComplianceChris Wubbolt, Principal Consultant, QACV Consulting, LLC

2

In this closed-door session, senior-level validation and quality professionals engage in open discussions with colleagues about strategies for data integrity compliance. The content for this summit is driven by participants, who are surveyed ahead of

time about the topics they wish to discuss. The session is open to the first 15 senior-level professionals who pre-register for the interactive discussion group. In order to pre-register, you must have over five years of experience and currently work for

a pharmaceutical, biotechnology or medical device company. *IVT reserves the right to qualify

participants for this workshop.

Bob Buhlmann, Director Corporate Quality Assurance, Amgen, Inc.

Discuss Key Data Integrity Challenges and Brainstorm Solutions

Senior-Level Think

Tank1


Are you trying to develop and implement a global data integrity governance program, or get one back on track to meet the current regulatory guidelines? This session provides you real-life examples of both challenges and winning strategies to successfully run a global program.

I. Design Your Data Integrity Program• Establish the design of the structure and resources of

the program and how to engage senior management

• Define the scope of business processes and systems

II. Detect and Remediate Gaps• Determine the tools for assessment and data process

mapping to find gaps and define critical data• Standardize gap remediation and harmonize across

many sites

III. Inspection Preparation• Prepare for inspections and explain your program

• Plan training and communicationsCathlin Shapiro, MBA, CISA, Associate Director, eSystems Compliance and Quality Programs, Global Quality, Bristol-Myers Squibb


Translate Strategy into Action — Create Effective Procedures to Support Your Data Integrity Program

I. Governance Documents• Documenting your strategy

• Data integrity basics — ALCOA+

• Procedure basics — What makes a procedure effective?

II. Data Integrity Program• What procedures

are impacted?

• Write actionable procedures to support your data integrity program

• Identify your procedural gaps

• Maintain procedure compliance

III. Interactive ExerciseSelecting a specific data integrity requirement, participants drill down on how to document strategy in actionable procedures.

Lizzandra Rivera, Senior Manager, IT Quality, Alexion Pharmaceuticals

4

Applying the appropriate configuration management to software is an aspect of data integrity that is sometimes under-appreciated, yet it is fundamental to compliant use of the system. This session evaluates the relationship between roles/software access privileges and use of the system. Practical examples include review of a Chromatography Data System (CDS) and other laboratory systems.

I. Workflow Mapping• Understand the workflow

fundamental to configuring the system for use

• Workflow mapping for system usage

• Gap analysis and options

• Example workflows for different types of laboratory systems

II. Consideration of Access Configuration• Logistics for business

continuity

• Data integrity risks associated with configurations

• Gap Analysis — How to review system configuration

• What auditors will look for

III. Data Life Cycle Mapping• Understanding the data life is

fundamental to data integrity and “defence” of the system

• Review examples of data lifecycle mapping

• Risk categorization

IV. Interactive Exercise• Workflow mapping

• Review of CDS configurations

Bonus Material• Summary of regulatory

actions associated with system configuration

Paul Smith, Global Strategic Compliance Manager, Agilent Technologies


10:15 NETWORKING AND REFRESHMENT BREAK


Configuring Software for Data Integrity

12:15 NETWORKING LUNCHEON

The How To’s and How Not To’s — A Case Study of Data Integrity Governance Implementation

3

5



2:45 NETWORKING AND REFRESHMENT BREAK

4:30 CLOSE OF CONFERENCE

3:00 MOCK AUDIT 360°Applying Data Integrity Learnings from Health Authority Inspections

I. Collection• Identify, label, record and

acquire digital assets from all possible quality sources, while following procedures that preserve the integrity of the data

II. Examination• Forensically process collected

data using a combination of automated and manual methods

• Assess and extract data of particular interest, while preserving the data’s chain of custody

III. Analysis• Analyze the results of the

examination, using legally justifiable methods and techniques

• Derive useful information that addresses the questions that were the impetus for performing the collection and examination

IV. Reporting• Report the results of

the analysis

• Describe the incident and how it occurred

• Discuss which factors contributed to the incident and how to prevent future incidents

• Provide recommendations for

remedial corrective actions

as appropriate

• Document conclusions derived

from the analysis

V. Interactive ExerciseUsing a real-life example,

participants break into teams

and perform an examination

and analysis of a data integrity

scenario. The teams then report

the results of their findings.

Armin Torres, Principal,

Qualified Data SystemsJavier Dominguez, Senior Consultant,

Qualified Data Systems

Utilize Forensic Methodology to Determine the Root Cause of a Data Integrity Issue6

I. Preparation, Preparation, Preparation• Know your technical landscape

• Know your processes and controls

• Know your data

• Know your company’s culture

• Roles and responsibilities

• Strategies and practice

II. Regulatory Objectives• Ensure patient safety, product quality and

data integrity

• Ensure comprehensive understanding of the data to support decisions

• Evaluation of controls and behaviors to protect the records

III. Interactive Exercise• Group role play with presenters and audience

Bonus Material:• Warning letter – A Roadmap to Data Integrity

Presented By: James Waterbury, MBA, Associate Director, Computer Systems/Data Integrity, Global Compliance and Ethics, BioMarin Pharmaceutical Inc.

Jay Waterbury joined BioMarin in 2015 as the initial member of its Global Compliance & Ethics group to establish a center of excellence focusing on computer systems and data integrity. Jay has 20+ years of experience specializing in computer systems compliance in a variety biotech and pharmaceutical companies ranging from mid-sized to global.

Loren Smith, Senior Manager, Computer Systems/Data Integrity, Global Compliance and Ethics, BioMarin Pharmaceutical Inc.

Loren Smith joined BioMarin in 2017 as a senior member of its Global Compliance and Ethics group, focusing on computer systems and data integrity. Loren came to BioMarin with 28 years of experience specializing in computer systems compliance in medical device, biotech, pharmaceutical, and analytical instrumentation companies. Loren has also been an instructor at University of California Berkeley, since 2006, teaching computer systems compliance to students in clinical research.



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A GREAT PLACE TO MEET YOUR MARKET

Take 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:

PREVIOUS ATTENDEE ACCLAIM:“If you need ideas to mitigate data integrity issues, you have to join this conference.”

— Head, GYPIT Audit Management, Bayer Pharma

“Very nice discussions and presenters that help us to have an industry perspective on new trends.”

— QA Specialist, Corp. GxPCRs, Amgen

“I always take away some useful information. This conference provided good, useful information and some practical examples.”

— Director/Head of QA, CSV, Daiichi Sankyo

“Great industry insight into data integrity calculation, audit trail reviews and cloud data storage notes and benefits.”

— Specialist, Global QA-CSV, Apotex


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IVT’s Data Integrity Validation PI17123

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Register by June 16, 2017 and SAVE $300. Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.) PLEASE NOTE: All advertised discounts are taken from the full, Standard Rate.

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CHOOSE BREAKOUT SESS IONS BELOW

Thursday, August 17, 20177:45 - 8:30 A B

8:30 - 10:00 1 2

10:30 - 12:00 3 4

1:15 - 2:45 5 6

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 1 6 , 2 0 1 7 A N D S AV E $ 3 0 0 !

A U G U S T 1 6 - 1 7 , 2 0 1 7 • W E S T I N S A N D I E G O • S A N D I E G O , CA

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Data Integrity Validation

AU G U S T 1 6 - 1 7 , 2 0 1 7 • W E S T I N S A N D I E G O • S A N D I E G O, CA


3rd Annual









