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Agenda

Industry's Leader in CSV Excellence

April 25-27, 2018
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, APRIL 25, 2018

12:00

Conference Registration

1:15

Chairperson’s Welcome and Opening Remarks

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

1:30

Where Do We Stand with Data Integrity in 2018?
An Update on the Regulatory Landscape

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

2:15

SPOTLIGHT SESSIONIdentify and Integrate Best Practices for Maintaining Data Integrity in Emerging Markets

Kevin Martin, General Manager, Azzur Group

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

3:00

Networking and Refreshment Break

Office Hours — Meet one-on-one with speakers to solve your individual computer and software validation challenges

3:30

Automated QMS System and Tools —
Common Challenges and How to Address Them

Michael Viscido
Senior Director, Quality and Technical Services
Mallinckrodt Pharmaceuticals

4:15

GAME CHANGER! An FDA/Industry Collaboration Update on Non-Product CSV

Khaled Moussally
Head of Quality Management Systems
Compliance Group

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

Francisco Vicenty
Program Manager, Case for Quality, Office of Compliance
CDRH, U.S. FDA

5:15

Close of Day One

NETWORKING RECEPTION Join your colleagues for an extra inning after the event. Hosted by IVT’s upcoming 4th Annual Data Integrity Validation event, this year’s networking mixer is themed after the conference’s 2018 location — Boston! Attendees are encouraged to put their baseball caps on, and enjoy a small taste of Fenway — Stadium snacks, beer and wine will be served.

DAY TWO THURSDAY, APRIL 26, 2018

8:30

Continental Breakfast and Office Hours

9:00

CHOOSE BETWEEN THREE 90-MINUTE SESSIONS (1-3)

1 Navigate the Technical, Procedural and Behavioral Controls in 21 CFR Part 11 Compliance

I. Definitions

II. Procedures and Controls

III. Hands-On Exercise

Laurent Saugrin
Computer Validation Specialist IV, IT Compliance
Dexcom

2 Leave Paper Archiving in the Past — Here’s How to Move to a Cost Effective Electronic Validation Solution

I. Electronic Validation Basics

II. Cost Effective Implementation

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

3 Perform a Gap Analysis, Assess Gap Areas and Determine a Plan of Action for Managing Risk in Identified Risk Areas

I. Gap Analysis

II. Assess Gap Areas

III. Plan of Action for Managing Risk in Identified Risk Areas

IV. Hands-On Exercise

J. Sean Osso
Consulting Engineer/Quality Engineer
Osso2 Consulting Group and TMJ Concepts

10:30

Networking and Refreshment Break

Office Hours — Meet one-on-one with speakers to solve your individual computer and software validation challenges

11:00

CHOOSE FROM THREE 90-MINUTE SESSIONS (4-6)

4 Evaluate and Improve Emergency Change Control Procedures

I. What Is an Emergency Change Control?

II. Testing, Documentation and Lessons Learned

III. Hands-On Exercise

Holly Baldwin
Senior Validation Advisor
UL Compliance to Performance

5 SENIOR-LEVEL THINK TANK Gain Best Practices and Proven Techniques for Achieving CSV Excellence

In this closed-door session, senior-level validation and quality professionals engage in open discussions with colleagues about strategies for computer software and systems validation excellence. 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 in validation and currently work for a bio/ pharmaceutical or medical device company.

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

6 Deploy and Validate Tools for Agile Systems Implementation — Insight to a Validation Approach Suited for Agile Systems Deployment

I. Overview of Agile

II. Hands-On Exercise — Use the Least Burdensome Approach

III. Automation Is Key

Atulkumar Darji, PMP, CISA
Senior Manager, Technology and Quality
Johnson & Johnson

11:00

CHOOSE BETWEEN TWO
INTERACTIVE 3-HOUR WORKSHOPS (7-8)

7 Establish a Plan for Transitioning to a Cloud-Based Validation Environment

I. Understanding Cloud vs. Physical Environments

II. Risks and Rewards of a Cloud-Based Environment

III. Prepare a Validation Plan for Transition to a Cloud-Based Environment

IV. On-Going Monitoring and Support

V. Hands-On Exercise

Holly Baldwin
Senior Validation Advisor
UL Compliance to Performance

 
8 Conduct a Self-Assessment of Your Data Integrity Effectiveness through the GAMP Data Integrity Maturity Model

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

II. Review the Data Integrity Maturity Model

III. Conduct the Self-Assessment

IV. Hands-On Exercise

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

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

5:00

Close of Day Two

ENHANCED NETWORKING Convene with conference peers in the hotel lobby at 5:30 to
meet dinner companions! The IVT Team will provide restaurant recommendations within walking distance for you to enjoy together!

DAY THREE FRIDAY, APRIL 27, 2018

8:30

Continental Breakfast and Office Hours

CHOOSE BETWEEN THREE 90-MINUTE SESSIONS (9-11)

9 CASE STUDY SHOWDOWN Examine Organizational Experiences Transitioning to an Agile System

I. Case Study I — Sharing Agile Transition Experience from J&J

II. Case Study II — Integrating Agile Software Development with the Traditional Computer Systems Validation Lifecycle

Jim Gunning
Director, Quality CSV
Johnson & Johnson

Jason Tepfenhardt, Co-Founder and Managing Partner, Tx3 Services LLC

10 Documents Part I — Death by Documents and How to Avoid It

I. Introduction — How Healthy Is Your Process?

II. Document Development — How to Get it Right the First Time

III. Document Review — How to Make it Happen Fast

IV. Document Approval — How to Avoid Last Minute Surprises

V. Hands-On Exercise

Cynthia Pleach
Information Technology Compliance and Governance Manager
NewLink Genetics

11 Establish GMP Compliant Cloud Software Validation Procedures

I. Cloud Provider Audit Procedure and Documentation

II. Validation Procedure and Deliverables

III. Hands-On Exercise

Laurent Saugrin
Computer Validation Specialist IV, IT Compliance
Dexcom

10:30

Networking and Refreshment Break

Office Hours — Meet one-on-one with speakers to solve your individual computer and software validation challenges

11:00

CHOOSE FROM TWO 90-MINUTE SESSIONS (12-13)

12 Create Strategic Alliances between IT and Quality to Achieve Compliance

I. Successful Delivery of Quality and IT Services to the Business

II. Effective Use of Quality and IT Resources (People, Process, Technology)

III. Implement the “Lean Compliance” Initiative

IV. Hands-On Exercise

Manuel Torres, PhD
A-Director, Quality Systems and Compliance Systems Validation
Ironwood Pharmaceuticals

13 Collaborative Power Hour Documents Part II — Exchange Strategies for Efficient Software Documentation and SOP Development

Join us in this interactive session to discuss best practices, successes and challenges in dealing with documentation. Participants use key documents to discuss high-level content, regulatory challenges and trends, based on the interest of the audience. Bring your documents or process questions and be prepared to share your successes and/or challenges.

I. Software Documentation

II. Procedure Development

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

12:30

Lunch Buffet Opens

12:45

LUNCHEON AND CLOSING SESSION | Prepare Your Systems for a Comprehensive Data Integrity Audit

I. Regulations, Standards and Expectations

II. Data Integrity Review for the System

III. Data Integrity Methodology

IV. Perform a Data Integrity Audit using Simulated Data Scenario(s)

V. Establish and Integrate Data Management System

VI. Hands-On Exercise

J. Sean Osso
Consulting Engineer/Quality Engineer
Osso2 Consulting Group and TMJ Concepts

2:15

Close of Conference

Agenda

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

DAY ONE WEDNESDAY, APRIL 25, 2018

12:00

Conference Registration

1:15

Chairperson’s Welcome and Opening Remarks

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

1:30

Where Do We Stand with Data Integrity in 2018?
An Update on the Regulatory Landscape

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

2:15

SPOTLIGHT SESSIONIdentify and Integrate Best Practices for Maintaining Data Integrity in Emerging Markets

Kevin Martin, General Manager, Azzur Group

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

3:00

Networking and Refreshment Break

Office Hours — Meet one-on-one with speakers to solve your individual computer and software validation challenges

3:30

Automated QMS System and Tools —
Common Challenges and How to Address Them

Michael Viscido
Senior Director, Quality and Technical Services
Mallinckrodt Pharmaceuticals

4:15

GAME CHANGER! An FDA/Industry Collaboration Update on Non-Product CSV

Khaled Moussally
Head of Quality Management Systems
Compliance Group

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

Francisco Vicenty
Program Manager, Case for Quality, Office of Compliance
CDRH, U.S. FDA

5:15

Close of Day One

NETWORKING RECEPTION Join your colleagues for an extra inning after the event. Hosted by IVT’s upcoming 4th Annual Data Integrity Validation event, this year’s networking mixer is themed after the conference’s 2018 location — Boston! Attendees are encouraged to put their baseball caps on, and enjoy a small taste of Fenway — Stadium snacks, beer and wine will be served.

DAY TWO THURSDAY, APRIL 26, 2018

8:30

Continental Breakfast and Office Hours

9:00

CHOOSE BETWEEN THREE 90-MINUTE SESSIONS (1-3)

1 Navigate the Technical, Procedural and Behavioral Controls in 21 CFR Part 11 Compliance

I. Definitions

II. Procedures and Controls

III. Hands-On Exercise

Laurent Saugrin
Computer Validation Specialist IV, IT Compliance
Dexcom

2 Leave Paper Archiving in the Past — Here’s How to Move to a Cost Effective Electronic Validation Solution

I. Electronic Validation Basics

II. Cost Effective Implementation

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

3 Perform a Gap Analysis, Assess Gap Areas and Determine a Plan of Action for Managing Risk in Identified Risk Areas

I. Gap Analysis

II. Assess Gap Areas

III. Plan of Action for Managing Risk in Identified Risk Areas

IV. Hands-On Exercise

J. Sean Osso
Consulting Engineer/Quality Engineer
Osso2 Consulting Group and TMJ Concepts

10:30

Networking and Refreshment Break

Office Hours — Meet one-on-one with speakers to solve your individual computer and software validation challenges

11:00

CHOOSE FROM THREE 90-MINUTE SESSIONS (4-6)

4 Evaluate and Improve Emergency Change Control Procedures

I. What Is an Emergency Change Control?

II. Testing, Documentation and Lessons Learned

III. Hands-On Exercise

Holly Baldwin
Senior Validation Advisor
UL Compliance to Performance

5 SENIOR-LEVEL THINK TANK Gain Best Practices and Proven Techniques for Achieving CSV Excellence

In this closed-door session, senior-level validation and quality professionals engage in open discussions with colleagues about strategies for computer software and systems validation excellence. 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 in validation and currently work for a bio/ pharmaceutical or medical device company.

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

6 Deploy and Validate Tools for Agile Systems Implementation — Insight to a Validation Approach Suited for Agile Systems Deployment

I. Overview of Agile

II. Hands-On Exercise — Use the Least Burdensome Approach

III. Automation Is Key

Atulkumar Darji, PMP, CISA
Senior Manager, Technology and Quality
Johnson & Johnson

11:00

CHOOSE BETWEEN TWO
INTERACTIVE 3-HOUR WORKSHOPS (7-8)

7 Establish a Plan for Transitioning to a Cloud-Based Validation Environment

I. Understanding Cloud vs. Physical Environments

II. Risks and Rewards of a Cloud-Based Environment

III. Prepare a Validation Plan for Transition to a Cloud-Based Environment

IV. On-Going Monitoring and Support

V. Hands-On Exercise

Holly Baldwin
Senior Validation Advisor
UL Compliance to Performance

 
8 Conduct a Self-Assessment of Your Data Integrity Effectiveness through the GAMP Data Integrity Maturity Model

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

II. Review the Data Integrity Maturity Model

III. Conduct the Self-Assessment

IV. Hands-On Exercise

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

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

5:00

Close of Day Two

ENHANCED NETWORKING Convene with conference peers in the hotel lobby at 5:30 to
meet dinner companions! The IVT Team will provide restaurant recommendations within walking distance for you to enjoy together!

DAY THREE FRIDAY, APRIL 27, 2018

8:30

Continental Breakfast and Office Hours

CHOOSE BETWEEN THREE 90-MINUTE SESSIONS (9-11)

9 CASE STUDY SHOWDOWN Examine Organizational Experiences Transitioning to an Agile System

I. Case Study I — Sharing Agile Transition Experience from J&J

II. Case Study II — Integrating Agile Software Development with the Traditional Computer Systems Validation Lifecycle

Jim Gunning
Director, Quality CSV
Johnson & Johnson

Jason Tepfenhardt, Co-Founder and Managing Partner, Tx3 Services LLC

10 Documents Part I — Death by Documents and How to Avoid It

I. Introduction — How Healthy Is Your Process?

II. Document Development — How to Get it Right the First Time

III. Document Review — How to Make it Happen Fast

IV. Document Approval — How to Avoid Last Minute Surprises

V. Hands-On Exercise

Cynthia Pleach
Information Technology Compliance and Governance Manager
NewLink Genetics

11 Establish GMP Compliant Cloud Software Validation Procedures

I. Cloud Provider Audit Procedure and Documentation

II. Validation Procedure and Deliverables

III. Hands-On Exercise

Laurent Saugrin
Computer Validation Specialist IV, IT Compliance
Dexcom

10:30

Networking and Refreshment Break

Office Hours — Meet one-on-one with speakers to solve your individual computer and software validation challenges

11:00

CHOOSE FROM TWO 90-MINUTE SESSIONS (12-13)

12 Create Strategic Alliances between IT and Quality to Achieve Compliance

I. Successful Delivery of Quality and IT Services to the Business

II. Effective Use of Quality and IT Resources (People, Process, Technology)

III. Implement the “Lean Compliance” Initiative

IV. Hands-On Exercise

Manuel Torres, PhD
A-Director, Quality Systems and Compliance Systems Validation
Ironwood Pharmaceuticals

13 Collaborative Power Hour Documents Part II — Exchange Strategies for Efficient Software Documentation and SOP Development

Join us in this interactive session to discuss best practices, successes and challenges in dealing with documentation. Participants use key documents to discuss high-level content, regulatory challenges and trends, based on the interest of the audience. Bring your documents or process questions and be prepared to share your successes and/or challenges.

I. Software Documentation

II. Procedure Development

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

12:30

Lunch Buffet Opens

12:45

LUNCHEON AND CLOSING SESSION | Prepare Your Systems for a Comprehensive Data Integrity Audit

I. Regulations, Standards and Expectations

II. Data Integrity Review for the System

III. Data Integrity Methodology

IV. Perform a Data Integrity Audit using Simulated Data Scenario(s)

V. Establish and Integrate Data Management System

VI. Hands-On Exercise

J. Sean Osso
Consulting Engineer/Quality Engineer
Osso2 Consulting Group and TMJ Concepts

2:15

Close of Conference