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Agenda

Learn and Refine Data Integrity Best Practices for Cloud, Agile, Waterfall and SaaS Models

August 14-15, 2019
  • Waltham, MA

Agenda

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, AUGUST 14, 2019

8:00

Registration and Continental Breakfast

8:45

Chairman’s Welcome and Opening Remarks

Ed Eirikis
Senior Computer Validation and Compliance Manager
Janssen BioTherapeutics

9:00

TRAILBLAZER TALK Cognitive Disruption — Prepare for a New Way of Thinking about Processes, Computerized Systems and Holistic IT Solutions

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

9:45

Game Changer! Update on FDA and Industry Collaboration on Computer Software Assurance (CSA)

Khaled Moussally
Head of Quality
Compliance Group

Kurt Weber
Director of Information Technology
Vericel Corporation

Lou Poirier
Director IT, Quality Systems
Lantheus Medical Imaging

10:30

Networking and Refreshment Break

11:00

Process Makes Perfect —
Control Strategies for Supporting Data Integrity Compliance

Matthew Paquette
Product Specialist
Charles River

11:45

ROUNDTABLE DISCUSSION Discuss the Importance and Evolving Nature of Data Traceability

Stephen R. Ferrell CISA CRISC
Managing Director
Compliance Path

Kevin C. Martin
Managing Partner
Azzur Group LLC

12:30

Networking Luncheon

1:30

Promote a Systemic Culture of Data Integrity within Your
Department and Organization —
Learn How to Train Your Teams to Become Data Integrity Inspectors

Ruth Vale, PhD
Privacy and Compliance Officer
Express Scripts Canada

2:15

Walk Through the Evolution of Paper-Based, Paperless and Cloud-Based Data Systems to Discover the Best Data Governance Practices

Stephen R. Ferrell, CISA, CRISC
Managing Director
Compliance Path

Kevin C. Martin
Managing Partner
Azzur Group LLC

3:00

Networking and Refreshment Break

3:30

Minimize Risk During Your Digital Upgrade

Karen O’Connell
Director, Quality Compliance
Sanofi Genzyme

4:15

Bridge the Gaps in Data Integrity — Assess Risk to Streamline Audit Trail Review

Denise Diehr-New
Validation Engineer III
Hikma

5:30

Close of Day One

Networking, Wine & Cheese Reception immediately following the conclusion of day one

DAY TWO THURSDAY, AUGUST 15, 2019

8:00

Networking Breakfast

8:30

CHOOSE BETWEEN TWO CONCURRENT SESSIONS (1-2)

1 Extensions to FDA’s Non-Product CSV Model

Ed Eirikis
Senior Computer Validation and Compliance Manager
Janssen BioTherapeutics

2 Electronic Systems for Maintaining Lab Data Integrity

Ed Eirikis
Senior Computer Validation and Compliance Manager
Janssen BioTherapeutics

10:00

Networking and Refreshment Break

10:30

CHOOSE BETWEEN TWO CONCURRENT ACTIVITIES (3-4)

3 BYOC — Bring Your Own
Data Integrity Challenge Workshop

During this unique workshop, data integrity professionals share their greatest pain points and then collaborate with peers to develop strategies for managing their most pressing challenges. The content for the workshop is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

Chinmoy Roy
Industry Consultant, CSV and Data Integrity
ValGenesis

4 Senior-Level Think Tank —
Unpacking the Complexities of Big Data

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

12:00

Networking Luncheon

1:00

CHOOSE BETWEEN TWO CONCURRENT SESSIONS (5-6)

5 An Auditor’s Perspective on Data Integrity —
Evaluate Responsibilities for CMOs, CROs & CTLs

George Kuniholm, MBA
Principal
Cypress Compliance

6 Implement Cloud Solutions and
Best Practices for Vendor Management

Naveen Madaboina
Computer Systems Validation Engineer
Cook Myosite

2:30

Networking and Refreshment Break

3:00

MOCK INSPECTION Learn What to Expect from Auditors and Proactively Mitigate Potential Risks

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

3:45

Implementation of Effective Audit Trail Policy, Procedure and Technology

Matthew LaPierre
Data Integrity Industry Expert

4:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.
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Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, AUGUST 14, 2019

8:00

Registration and Continental Breakfast

8:45

Chairman’s Welcome and Opening Remarks

Ed Eirikis
Senior Computer Validation and Compliance Manager
Janssen BioTherapeutics

9:00

TRAILBLAZER TALK Cognitive Disruption — Prepare for a New Way of Thinking about Processes, Computerized Systems and Holistic IT Solutions

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

9:45

Game Changer! Update on FDA and Industry Collaboration on Computer Software Assurance (CSA)

Khaled Moussally
Head of Quality
Compliance Group

Kurt Weber
Director of Information Technology
Vericel Corporation

Lou Poirier
Director IT, Quality Systems
Lantheus Medical Imaging

10:30

Networking and Refreshment Break

11:00

Process Makes Perfect —
Control Strategies for Supporting Data Integrity Compliance

Matthew Paquette
Product Specialist
Charles River

11:45

ROUNDTABLE DISCUSSION Discuss the Importance and Evolving Nature of Data Traceability

Stephen R. Ferrell CISA CRISC
Managing Director
Compliance Path

Kevin C. Martin
Managing Partner
Azzur Group LLC

12:30

Networking Luncheon

1:30

Promote a Systemic Culture of Data Integrity within Your
Department and Organization —
Learn How to Train Your Teams to Become Data Integrity Inspectors

Ruth Vale, PhD
Privacy and Compliance Officer
Express Scripts Canada

2:15

Walk Through the Evolution of Paper-Based, Paperless and Cloud-Based Data Systems to Discover the Best Data Governance Practices

Stephen R. Ferrell, CISA, CRISC
Managing Director
Compliance Path

Kevin C. Martin
Managing Partner
Azzur Group LLC

3:00

Networking and Refreshment Break

3:30

Minimize Risk During Your Digital Upgrade

Karen O’Connell
Director, Quality Compliance
Sanofi Genzyme

4:15

Bridge the Gaps in Data Integrity — Assess Risk to Streamline Audit Trail Review

Denise Diehr-New
Validation Engineer III
Hikma

5:30

Close of Day One

Networking, Wine & Cheese Reception immediately following the conclusion of day one

DAY TWO THURSDAY, AUGUST 15, 2019

8:00

Networking Breakfast

8:30

CHOOSE BETWEEN TWO CONCURRENT SESSIONS (1-2)

1 Extensions to FDA’s Non-Product CSV Model

Ed Eirikis
Senior Computer Validation and Compliance Manager
Janssen BioTherapeutics

2 Electronic Systems for Maintaining Lab Data Integrity

Ed Eirikis
Senior Computer Validation and Compliance Manager
Janssen BioTherapeutics

10:00

Networking and Refreshment Break

10:30

CHOOSE BETWEEN TWO CONCURRENT ACTIVITIES (3-4)

3 BYOC — Bring Your Own
Data Integrity Challenge Workshop

During this unique workshop, data integrity professionals share their greatest pain points and then collaborate with peers to develop strategies for managing their most pressing challenges. The content for the workshop is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

Chinmoy Roy
Industry Consultant, CSV and Data Integrity
ValGenesis

4 Senior-Level Think Tank —
Unpacking the Complexities of Big Data

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

12:00

Networking Luncheon

1:00

CHOOSE BETWEEN TWO CONCURRENT SESSIONS (5-6)

5 An Auditor’s Perspective on Data Integrity —
Evaluate Responsibilities for CMOs, CROs & CTLs

George Kuniholm, MBA
Principal
Cypress Compliance

6 Implement Cloud Solutions and
Best Practices for Vendor Management

Naveen Madaboina
Computer Systems Validation Engineer
Cook Myosite

2:30

Networking and Refreshment Break

3:00

MOCK INSPECTION Learn What to Expect from Auditors and Proactively Mitigate Potential Risks

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

3:45

Implementation of Effective Audit Trail Policy, Procedure and Technology

Matthew LaPierre
Data Integrity Industry Expert

4:30

Close of Conference