Skip navigation

DAY ONE TUESDAY, APRIL 23, 2019

12:00

Conference Registration

1:00

Chairman’s Welcome and Opening Remarks

Harsha Chulki
Head of Global IT Quality & CSV
ICU Medical

1:15

CIO ADDRESS Engaging Digital Transformation — Achieve Increased Collaboration Through Innovations in Technology and Facility Design

With a unique combination of responsibilities as Chief Information Officer and Global Head of Facilities, Norm Fjeldheim shares his experiences in IT infrastructure, facility design and project implementation. Discover how these advances streamline overall business efficiencies and specifically influence the responsibilities of validation, engineering, IT and quality teams.

Norm Fjeldheim
Senior Vice President, Chief Information Officer
and Global Head of Facilities
Illumina

2:00

News Flash! Analyze FDA’s Data Integrity and Compliance with Drug CGMP Final Guidance for Industry

Chris Wubbolt
Principal
QACV Consulting, LLC

2:45

CSV TRENDS ADDRESS Innovations in Technology, Regulatory Shifts and Navigating the Global Data Privacy Landscape

Saurav Ghosh
Consulting Director
NNIT

3:30

Networking and Refreshment Break

4:00

REGULATORY INSIGHT PANEL Game Changer!
Update on FDA and Industry Collaboration on Computer Software Assurance

Moderator:

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

Panelists:

Jason Spiegler
Senior Director, Industry Portfolio Development
Siemens Product Lifecycle Management Software Inc.

Harsha Chulki
Head of Global IT Quality & CSV
ICU Medical

Kurt Weber
Director of IT
Vericel Corporation

Ken Shitamoto, MS
Senior Director, IT
Gilead Sciences

4:45

Validation for the Cloud —
Using Agile and Automation to Meet Validation Requirements

Loan Quach
Senior Manager, Quality Management Services
Box, Inc.

Jimmy Yeh
Validation Manager, Quality Management Services
Box, Inc.

5:30

Leaner and Efficient — Digital Validation Reimagined

Satyanarayana Patloori
Managing Director, Risk and Financial Advisory
Deloitte & Touche LLP

Vamsee Dasaka
Senior Manager, Risk and Financial Advisory
Deloitte & Touche LLP

6:00

Close of Day One

Please Join Us for a Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO WEDNESDAY, APRIL 24, 2019

8:00

Breakfast Buffet Opens

8:30

CHOOSE BETWEEN 2 EYE-OPENER BREAKFAST SESSIONS (A-B)

A Approach the Vendor Selection Process for Clinical Trials from a CSV Perspective —
Insights from a Virtual Pharma Company

Michael Gameng
Associate Director, GxP Enterprise Applications
MyoKardia

B Review 20 Years of e-Systems Compliance —
Then and Now

Chris Wubbolt
Principal
QACV Consulting, LLC

9:30

CHOOSE BETWEEN 3 EDUCATIONAL BREAKOUT SESSIONS (1-3)

1 ADVANCED/LEADERSHIP Building Collaborative Teams for Successful Validation

Joe Pierce
Founder, CEO
Endpoint Technologies

2 TECHNICAL PRACTICE Computer System Validation Process Innovation in Molecular Diagnostics

Shane Pew
Director of Quality Assurance
Myriad Genetics

3 IT/DATA MANAGEMENT Utilize a Lifecycle and Risk-Based Approach to Streamline the CSV Process for Clinical Trial SaaS

Doug Shaw, CISA
Director of IT & CSV Consulting
Azzur Group

Shana Kinney
Senior Manager, Computer Systems Validation
REGENXBIO Inc.

10:30

Networking and Refreshment Break

11:00

CHOOSE BETWEEN 2 EDUCATIONAL BREAKOUT SESSIONS (5-6)

5 TECHNICAL PRACTICE Risk-Based Computer Systems Validation — A Holistic Model

I. Background

II. System-Level Risk (SLR)

III. Leveraging Software Quality Assurance (SQA)

IV. Non-Product CSV

V. Interactive Exercise

Ken Shitamoto, MS
Senior Director, IT
Gilead Sciences

Senthil Gurumoorthi
Associate Director, IT Quality Assurance
Gilead Sciences

6 IT/DATA MANAGEMENT Bridging the Gaps in Data Integrity — Assess Risk to Streamline
Audit Trail Review

I. Define Data Integrity and Audit Trail Review

II. Understand Industry Guidelines

III. Develop a Risk-Based Approach (RBA) —
Know Your System and How Data Integrity Relates to It

IV. Interactive Exercise

V. Effectively Implement an Audit Trail Review Process

Denise Diehr-New
Validation Engineer III
Hikma

12:30

Networking Luncheon

1:30

CHOOSE BETWEEN 2 INTERACTIVE WORKSHOPS (7-8)

7 Cloud Computing and Cloud Validation Masterclass

In this 101-level workshop, participants compare and contrast the different types of cloud environments used in biopharma and medical device manufacturing, and learn how to maintain quality and data integrity in the cloud.

I. Evaluate the Different Cloud Environments

II. Manage Quality and Data Integrity in the Cloud

III. Case Study

IV. Interactive Audience Q&A

Workshop Leaders:

Lance Smith
IT Associate Director
Celgene

David Liu
Associate Director
Celgene

 
8 Managing Computer Systems Controls

Participants learn how to create appropriate processes and collaborate with vendors to ensure the overall quality of computer systems controls.

I. Identify Controls

II. Create a Data Flow Diagram and Assess Risks

III. Reconcile the Computer Systems Lifecycle with the Data Lifecycle

IV. Collaborate with Vendors to Manage Controls

V. Interactive Exercise

Workshop Leaders:

Calvin Kim
GXP IT Compliance Manager
Bayer

Chris Wubbolt
Principal
QACV Consulting, LLC

There will be a 30-minute break at approximately 3:00pm

5:00

Close of Day Two

DAY THREE THURSDAY, APRIL 25, 2019

8:30

Breakfast Buffet Opens

9:00

CHOOSE BETWEEN 3 EDUCATIONAL BREAKOUT SESSIONS (9-11)

9 ADVANCED/LEADERSHIP Advanced Collaborative Session — Strategies for Identifying and Procuring Resources to Meet CSV Business Needs

In this advanced collaborative, senior-level professionals engage in open discussions around managing CSV and IT teams, adapting to the changing regulatory environment and ensuring teams have the resources they need.

Harsha Chulki
Head of Global IT Quality & CSV
ICU Medical

10 TECHNICAL PRACTICE Effective Risk Management in
Validation

Regulators have historically suggested that industry take a risk-based approach to compliance. Guidance indicated that the preferred approach was to base the rigor of validations and other regulatory compliance issues on a documented and justified risk assessment. So, what does this mean in practice? This session presents a practical approach to incorporating risk management activities into the validation lifecycle.

Joseph Zec
Associate Director, CSV and Compliance
Shire plc

11 IT/DATA MANAGEMENT Implement or Migrate GXP Document and Quality Management Systems

Whether you’re going from pure paper to your first electronic system or upgrading/migrating to a new electronic system, there are many important decisions to make and considerations to plan for.

I. The Basics

II. How to Pick an Application

III. Implementation Considerations

IV. Case study

Jerry Anderson
Director, Quality Assurance
Ionis Pharmaceuticals

Paola DePaso
Director, Vault Quality
Veeva Systems

10:30

Networking and Refreshment Break

11:00

CHOOSE BETWEEN 3 EDUCATIONAL BREAKOUT SESSIONS (12-14)

12 ADVANCED/LEADERSHIP SaaS Validation Roundtable — Navigating the Challenging Single and Multi-Tenant SaaS Landscape

What exactly is SaaS? What is the risk of changing to a SaaS model? How does it impact the validation process? If you are thinking about changing to SaaS or struggling with implementing SaaS, join this roundtable to share experiences and hear from others.

I. Software as a Service

II. Impact to Validation and Supporting Processes

III. What to Do? What Not to Do?

Cynthia Pleach
Manager, Quality Assurance IT
Sage Therapeutics

13 TECHNICAL PRACTICE Prepare for FDA Audits and Inspections — The Ultimate CSV Handbook

I. Understand the Key Topics in CSV

II. A Practical Implementation of RiskBased Computerized System Validation

III. Interactive Exercise — Knowledge Exchange

Calvin Kim
GXP IT Compliance Manager
Bayer

14 IT/DATA MANAGEMENT Create Your Own Go-To Guide for GXP Systems Compliance — Documents, SOPs, Change Control and Audit Trails

I. Overview

II. Document Lifecycle

III. Interactive Exercise — A Day in the Life

Christine Foley Nash
Senior Manager, Validation
Kedrion Biopharma Inc.

12:30

Networking Luncheon and Vendor Prize Drawing

1:30

TOWN HALL Industry Benchmarking to Identify Gaps in Regulatory Guidance

Joseph Zec
Associate Director, CSV and Compliance
Shire plc

2:15

Chairman’s Closing Remarks

Harsha Chulki
Head of Global IT Quality & CSV
ICU Medical

2:30

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, APRIL 23, 2019

12:00

Conference Registration

1:00

Chairman’s Welcome and Opening Remarks

Harsha Chulki
Head of Global IT Quality & CSV
ICU Medical

1:15

CIO ADDRESS Engaging Digital Transformation — Achieve Increased Collaboration Through Innovations in Technology and Facility Design

With a unique combination of responsibilities as Chief Information Officer and Global Head of Facilities, Norm Fjeldheim shares his experiences in IT infrastructure, facility design and project implementation. Discover how these advances streamline overall business efficiencies and specifically influence the responsibilities of validation, engineering, IT and quality teams.

Norm Fjeldheim
Senior Vice President, Chief Information Officer
and Global Head of Facilities
Illumina

2:00

News Flash! Analyze FDA’s Data Integrity and Compliance with Drug CGMP Final Guidance for Industry

Chris Wubbolt
Principal
QACV Consulting, LLC

2:45

CSV TRENDS ADDRESS Innovations in Technology, Regulatory Shifts and Navigating the Global Data Privacy Landscape

Saurav Ghosh
Consulting Director
NNIT

3:30

Networking and Refreshment Break

4:00

REGULATORY INSIGHT PANEL Game Changer!
Update on FDA and Industry Collaboration on Computer Software Assurance

Moderator:

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

Panelists:

Jason Spiegler
Senior Director, Industry Portfolio Development
Siemens Product Lifecycle Management Software Inc.

Harsha Chulki
Head of Global IT Quality & CSV
ICU Medical

Kurt Weber
Director of IT
Vericel Corporation

Ken Shitamoto, MS
Senior Director, IT
Gilead Sciences

4:45

Validation for the Cloud —
Using Agile and Automation to Meet Validation Requirements

Loan Quach
Senior Manager, Quality Management Services
Box, Inc.

Jimmy Yeh
Validation Manager, Quality Management Services
Box, Inc.

5:30

Leaner and Efficient — Digital Validation Reimagined

Satyanarayana Patloori
Managing Director, Risk and Financial Advisory
Deloitte & Touche LLP

Vamsee Dasaka
Senior Manager, Risk and Financial Advisory
Deloitte & Touche LLP

6:00

Close of Day One

Please Join Us for a Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO WEDNESDAY, APRIL 24, 2019

8:00

Breakfast Buffet Opens

8:30

CHOOSE BETWEEN 2 EYE-OPENER BREAKFAST SESSIONS (A-B)

A Approach the Vendor Selection Process for Clinical Trials from a CSV Perspective —
Insights from a Virtual Pharma Company

Michael Gameng
Associate Director, GxP Enterprise Applications
MyoKardia

B Review 20 Years of e-Systems Compliance —
Then and Now

Chris Wubbolt
Principal
QACV Consulting, LLC

9:30

CHOOSE BETWEEN 3 EDUCATIONAL BREAKOUT SESSIONS (1-3)

1 ADVANCED/LEADERSHIP Building Collaborative Teams for Successful Validation

Joe Pierce
Founder, CEO
Endpoint Technologies

2 TECHNICAL PRACTICE Computer System Validation Process Innovation in Molecular Diagnostics

Shane Pew
Director of Quality Assurance
Myriad Genetics

3 IT/DATA MANAGEMENT Utilize a Lifecycle and Risk-Based Approach to Streamline the CSV Process for Clinical Trial SaaS

Doug Shaw, CISA
Director of IT & CSV Consulting
Azzur Group

Shana Kinney
Senior Manager, Computer Systems Validation
REGENXBIO Inc.

10:30

Networking and Refreshment Break

11:00

CHOOSE BETWEEN 2 EDUCATIONAL BREAKOUT SESSIONS (5-6)

5 TECHNICAL PRACTICE Risk-Based Computer Systems Validation — A Holistic Model

I. Background

II. System-Level Risk (SLR)

III. Leveraging Software Quality Assurance (SQA)

IV. Non-Product CSV

V. Interactive Exercise

Ken Shitamoto, MS
Senior Director, IT
Gilead Sciences

Senthil Gurumoorthi
Associate Director, IT Quality Assurance
Gilead Sciences

6 IT/DATA MANAGEMENT Bridging the Gaps in Data Integrity — Assess Risk to Streamline
Audit Trail Review

I. Define Data Integrity and Audit Trail Review

II. Understand Industry Guidelines

III. Develop a Risk-Based Approach (RBA) —
Know Your System and How Data Integrity Relates to It

IV. Interactive Exercise

V. Effectively Implement an Audit Trail Review Process

Denise Diehr-New
Validation Engineer III
Hikma

12:30

Networking Luncheon

1:30

CHOOSE BETWEEN 2 INTERACTIVE WORKSHOPS (7-8)

7 Cloud Computing and Cloud Validation Masterclass

In this 101-level workshop, participants compare and contrast the different types of cloud environments used in biopharma and medical device manufacturing, and learn how to maintain quality and data integrity in the cloud.

I. Evaluate the Different Cloud Environments

II. Manage Quality and Data Integrity in the Cloud

III. Case Study

IV. Interactive Audience Q&A

Workshop Leaders:

Lance Smith
IT Associate Director
Celgene

David Liu
Associate Director
Celgene

 
8 Managing Computer Systems Controls

Participants learn how to create appropriate processes and collaborate with vendors to ensure the overall quality of computer systems controls.

I. Identify Controls

II. Create a Data Flow Diagram and Assess Risks

III. Reconcile the Computer Systems Lifecycle with the Data Lifecycle

IV. Collaborate with Vendors to Manage Controls

V. Interactive Exercise

Workshop Leaders:

Calvin Kim
GXP IT Compliance Manager
Bayer

Chris Wubbolt
Principal
QACV Consulting, LLC

There will be a 30-minute break at approximately 3:00pm

5:00

Close of Day Two

DAY THREE THURSDAY, APRIL 25, 2019

8:30

Breakfast Buffet Opens

9:00

CHOOSE BETWEEN 3 EDUCATIONAL BREAKOUT SESSIONS (9-11)

9 ADVANCED/LEADERSHIP Advanced Collaborative Session — Strategies for Identifying and Procuring Resources to Meet CSV Business Needs

In this advanced collaborative, senior-level professionals engage in open discussions around managing CSV and IT teams, adapting to the changing regulatory environment and ensuring teams have the resources they need.

Harsha Chulki
Head of Global IT Quality & CSV
ICU Medical

10 TECHNICAL PRACTICE Effective Risk Management in
Validation

Regulators have historically suggested that industry take a risk-based approach to compliance. Guidance indicated that the preferred approach was to base the rigor of validations and other regulatory compliance issues on a documented and justified risk assessment. So, what does this mean in practice? This session presents a practical approach to incorporating risk management activities into the validation lifecycle.

Joseph Zec
Associate Director, CSV and Compliance
Shire plc

11 IT/DATA MANAGEMENT Implement or Migrate GXP Document and Quality Management Systems

Whether you’re going from pure paper to your first electronic system or upgrading/migrating to a new electronic system, there are many important decisions to make and considerations to plan for.

I. The Basics

II. How to Pick an Application

III. Implementation Considerations

IV. Case study

Jerry Anderson
Director, Quality Assurance
Ionis Pharmaceuticals

Paola DePaso
Director, Vault Quality
Veeva Systems

10:30

Networking and Refreshment Break

11:00

CHOOSE BETWEEN 3 EDUCATIONAL BREAKOUT SESSIONS (12-14)

12 ADVANCED/LEADERSHIP SaaS Validation Roundtable — Navigating the Challenging Single and Multi-Tenant SaaS Landscape

What exactly is SaaS? What is the risk of changing to a SaaS model? How does it impact the validation process? If you are thinking about changing to SaaS or struggling with implementing SaaS, join this roundtable to share experiences and hear from others.

I. Software as a Service

II. Impact to Validation and Supporting Processes

III. What to Do? What Not to Do?

Cynthia Pleach
Manager, Quality Assurance IT
Sage Therapeutics

13 TECHNICAL PRACTICE Prepare for FDA Audits and Inspections — The Ultimate CSV Handbook

I. Understand the Key Topics in CSV

II. A Practical Implementation of RiskBased Computerized System Validation

III. Interactive Exercise — Knowledge Exchange

Calvin Kim
GXP IT Compliance Manager
Bayer

14 IT/DATA MANAGEMENT Create Your Own Go-To Guide for GXP Systems Compliance — Documents, SOPs, Change Control and Audit Trails

I. Overview

II. Document Lifecycle

III. Interactive Exercise — A Day in the Life

Christine Foley Nash
Senior Manager, Validation
Kedrion Biopharma Inc.

12:30

Networking Luncheon and Vendor Prize Drawing

1:30

TOWN HALL Industry Benchmarking to Identify Gaps in Regulatory Guidance

Joseph Zec
Associate Director, CSV and Compliance
Shire plc

2:15

Chairman’s Closing Remarks

Harsha Chulki
Head of Global IT Quality & CSV
ICU Medical

2:30

Close of Conference