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Agenda

Overcome Roadblocks, Identify Solutions and Implement Processes for a Successful Data Governance Program

August 15-16, 2018
  • Cambridge, MA

Agenda

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, AUGUST 15, 2018

7:30

Registration and Continental Breakfast

8:15

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 Standards

Orlando López
E-Compliance and E-Records Integrity
SME

9:15

Analyze MHRA’s New GXP Data Integrity Guidance

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

10:00

Networking and Refreshment Break
Office Hours — Meet one-on-one w/ speakers to solve your individual data integrity challenges

10:30

“Homo Sapiens atque Integritas Notitia” (Human Beings and 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 Improvements

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

Shaun LeBlanc
Senior Manager, Professional Services
ValGenesis, Inc.

12:00

Networking Luncheon

1:00

Eliminate Risk and Human Error in Manufacturing and Laboratory Processes

Matthew Paquette
Product Specialist
Charles River

1:45

CHOOSE BETWEEN TWO IN-CONFERENCE WORKSHOPS (A-B)

A INTERMEDIATE Implement a Data Governance Plan that Suits
Your Organization’s Processes

I. Understand Regulatory Requirements for Data Integrity (DI)

II. Explore Data Integrity Guidances from Different Regulatory Agencies

III. Learn How to Use “The Least Burdensome Approach” to Develop Your DI Plan

IV. Develop a Data Integrity Management System

V. Interactive Exercise

Chinmoy Roy
Senior Systems Application Engineer, Genentech (retired);
Independent Consultant

B ADVANCED Utilize the GAMP Data Integrity Maturity Model
to Assess Your Effectiveness

I. Overview of the GAMP Guide on Electronic Records and Data Integrity

II. Review the Data Integrity Maturity Model

III. Conducting the Self-Assessment

IV. Interactive Exercise

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

Calvin Kim
Senior GXP IT Auditor
Bayer

There will be a networking and refreshment break at 3:15pm

5:15

Close of Day One

NETWORKING RECEPTION HOSTED BY:
immediately following the final session on day one

DAY TWO THURSDAY, AUGUST 16, 2018

7:30

Continental Breakfast
Office Hours — Meet one-on-one w/ speakers to solve your individual data integrity challenges

8:00

Chairman’s Review of Day One

Robert 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 Process

Bruce Kratz
Chief Technology Officer
Sparta Systems

9:00

Implement Cyber Security Best Practices to Support IT Data Governance Programs

Bryan Blank
Principal & Chief Information Officer
Sharp Point Security Solutions, LLC

Ryan Ott
Managing Partner
Azzur Group, LLC

9:45

Networking and Refreshment Break
Office Hours — Meet one-on-one w/ speakers to solve your individual data integrity challenges

10:15

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (1-2)

1 GMP FOCUS Interpret FDA and MHRA Guidelines From a
Manufacturing Mindset

I. What Is Data Integrity?

II. FDA Regulations and Guidances

III. MHRA

IV. Regulations and Guidance Related to Data Integrity for Computerized Systems

V. From Paper to Electronic

VI. How Do We Ensure the Integrity of Our Electronic Data in Validated Computerized Systems?

Raul Soto
Senior Principal Engineer
Johnson & Johnson Vision Care

2 GCP FOCUS Navigate Data Integrity Expectations in
the GCP Environment

I. Overview of the GCP Data Integrity Requirements

II. e-Clinical Systems and Examples

III. Conduct GCP Data Integrity Assessments

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

11:45

Networking Luncheon

12:45

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (3-4)

3 GMP & GCP FOCUS It’s Elementary! Detecting Data Integrity Lapses in the Laboratory, Manufacturing and Clinical Environments

I. You Keep Using That Word, I Do Not Think It Means What You Think It Means!

II. New Rules

III. Can You See What I See?

IV. Which One of These Things Is Not Like the Other?

V. Let’s Play! Interactive Exercise

Felicia Ford-Rice
Director
PAREXEL International

4 GMP FOCUS Apply Data Governance to Manufacturing Systems
and Process Automation

I. Manufacturing Technology Overview

II. Components of Data Governance

III. Assess Legacy Systems

IV. Interactive Exercise — Assess Legacy Systems

V. Building Data Integrity Into Systems

Steven Brown, BSE, MBA, CSSBB
Senior Manager, Systems and Technology Management
Celgene Corporation

2:15

Networking and Refreshment Break
Office Hours — Meet one-on-one w/ speakers to solve your individual data integrity challenges

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

II. You Still Haven’t Found What They’re Looking For...

III. Inspectional Observations and Responses

IV. Interactive Exercise

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

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 International

Teri Stokes
Director, Quality Assurance Compliance
Cytel

Chinmoy Roy
Senior Systems Application Engineer, Genentech (retired);
Independent Consultant

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

5:00

Chairman’s Closing Remarks and Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, AUGUST 15, 2018

7:30

Registration and Continental Breakfast

8:15

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 Standards

Orlando López
E-Compliance and E-Records Integrity
SME

9:15

Analyze MHRA’s New GXP Data Integrity Guidance

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

10:00

Networking and Refreshment Break
Office Hours — Meet one-on-one w/ speakers to solve your individual data integrity challenges

10:30

“Homo Sapiens atque Integritas Notitia” (Human Beings and 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 Improvements

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

Shaun LeBlanc
Senior Manager, Professional Services
ValGenesis, Inc.

12:00

Networking Luncheon

1:00

Eliminate Risk and Human Error in Manufacturing and Laboratory Processes

Matthew Paquette
Product Specialist
Charles River

1:45

CHOOSE BETWEEN TWO IN-CONFERENCE WORKSHOPS (A-B)

A INTERMEDIATE Implement a Data Governance Plan that Suits
Your Organization’s Processes

I. Understand Regulatory Requirements for Data Integrity (DI)

II. Explore Data Integrity Guidances from Different Regulatory Agencies

III. Learn How to Use “The Least Burdensome Approach” to Develop Your DI Plan

IV. Develop a Data Integrity Management System

V. Interactive Exercise

Chinmoy Roy
Senior Systems Application Engineer, Genentech (retired);
Independent Consultant

B ADVANCED Utilize the GAMP Data Integrity Maturity Model
to Assess Your Effectiveness

I. Overview of the GAMP Guide on Electronic Records and Data Integrity

II. Review the Data Integrity Maturity Model

III. Conducting the Self-Assessment

IV. Interactive Exercise

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

Calvin Kim
Senior GXP IT Auditor
Bayer

There will be a networking and refreshment break at 3:15pm

5:15

Close of Day One

NETWORKING RECEPTION HOSTED BY:
immediately following the final session on day one

DAY TWO THURSDAY, AUGUST 16, 2018

7:30

Continental Breakfast
Office Hours — Meet one-on-one w/ speakers to solve your individual data integrity challenges

8:00

Chairman’s Review of Day One

Robert 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 Process

Bruce Kratz
Chief Technology Officer
Sparta Systems

9:00

Implement Cyber Security Best Practices to Support IT Data Governance Programs

Bryan Blank
Principal & Chief Information Officer
Sharp Point Security Solutions, LLC

Ryan Ott
Managing Partner
Azzur Group, LLC

9:45

Networking and Refreshment Break
Office Hours — Meet one-on-one w/ speakers to solve your individual data integrity challenges

10:15

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (1-2)

1 GMP FOCUS Interpret FDA and MHRA Guidelines From a
Manufacturing Mindset

I. What Is Data Integrity?

II. FDA Regulations and Guidances

III. MHRA

IV. Regulations and Guidance Related to Data Integrity for Computerized Systems

V. From Paper to Electronic

VI. How Do We Ensure the Integrity of Our Electronic Data in Validated Computerized Systems?

Raul Soto
Senior Principal Engineer
Johnson & Johnson Vision Care

2 GCP FOCUS Navigate Data Integrity Expectations in
the GCP Environment

I. Overview of the GCP Data Integrity Requirements

II. e-Clinical Systems and Examples

III. Conduct GCP Data Integrity Assessments

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

11:45

Networking Luncheon

12:45

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (3-4)

3 GMP & GCP FOCUS It’s Elementary! Detecting Data Integrity Lapses in the Laboratory, Manufacturing and Clinical Environments

I. You Keep Using That Word, I Do Not Think It Means What You Think It Means!

II. New Rules

III. Can You See What I See?

IV. Which One of These Things Is Not Like the Other?

V. Let’s Play! Interactive Exercise

Felicia Ford-Rice
Director
PAREXEL International

4 GMP FOCUS Apply Data Governance to Manufacturing Systems
and Process Automation

I. Manufacturing Technology Overview

II. Components of Data Governance

III. Assess Legacy Systems

IV. Interactive Exercise — Assess Legacy Systems

V. Building Data Integrity Into Systems

Steven Brown, BSE, MBA, CSSBB
Senior Manager, Systems and Technology Management
Celgene Corporation

2:15

Networking and Refreshment Break
Office Hours — Meet one-on-one w/ speakers to solve your individual data integrity challenges

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

II. You Still Haven’t Found What They’re Looking For...

III. Inspectional Observations and Responses

IV. Interactive Exercise

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

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 International

Teri Stokes
Director, Quality Assurance Compliance
Cytel

Chinmoy Roy
Senior Systems Application Engineer, Genentech (retired);
Independent Consultant

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

5:00

Chairman’s Closing Remarks and Close of Conference