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Agenda

The Premier Validation Event for Medical Device and Diagnostics

March 13-15, 2018
  • Minneapolis, MN

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, MARCH 13, 2018

7:30

Conference Registration and Continental Breakfast

8:30

Workshop Leaders' Opening Remarks

CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS

WORKSHOP A Statistics in Validation Bootcamp

I. Learn the Process Capability Statistical Approach for Validation

II. Leverage Statistical Techniques From Process Validation for Design Verification

III. How to Choose Sample Sizes for Variables and Attributes Data

IV. Correlating Risk to Sample Size

V. Ansi Asq Z1.4 and Z1.9 Sampling Plans

VI. Hypothesis Testing and P-Values

WORKSHOP LEADER:

Roberta Goode
Principal
Altrec, LLC

WORKSHOP B Build Strategies and Implementation Plans for Test Method Validation (TMV)

I. TMV Overview

II. Tests vs. Test Methods

III. Strategies for Characterizing Tests for Use

IV. Validating Physical Test Methods

V. Validating Analytical Test Methods

WORKSHOP LEADER:

Tim Carr
Staff Quality Engineer
Abbott – Tendyne

*There will be a 30 minute networking and refreshment break at 10:00

12:00

Close of Workshop; Main Conference Registration

1:00

Chairperson’s Welcome and Opening Remarks

Ivonne del C. Ramos Miranda
Senior Validation Manager
Medtronic

Crucial Regulatory Updates for Medical Devices

1:15

Reevaluate Risk — The Case for Benefit Analysis in Validation

Adam E. Saltman, MD, PhD, FACS
Medical Officer, CDRH Office of Compliance
U.S. FDA

2:00

The FDA’s Case for Quality —
Promoting Organizational Excellence, Collaboration and Simplification

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

2:45

Review Updates in the Medical Device Single Audit Program (MDSAP)

CAPT Kim Lewandowski-Walker
National Expert, Medical Devices, Office of Regulatory Affairs
U.S. FDA

3:30

Networking and Refreshment Break

4:00

Examine the Practical Impact to Medical Device Manufacturers of the Evolving Global Regulatory Landscape (ISO 13485:2016, MDR, MEDDEV)

Donald Henderson
Senior Regulatory and Quality Consultant, ISO/MDR Transition Team
Johnson & Johnson’s Global Surgery Enterprise

4:45

Medical Device Validation Handbook — Ask the Authors Panel

Roberta Goode
Principal
Altrec, LLC

Matt Hedrick
External Manufacturing & Supply Quality Manager
Cordis

Ivonne del C. Ramos Miranda
Senior Validation Manager
Medtronic

William Knab
Principal
Matrix Technology Management

5:30

Close of Day One

PLEASE JOIN US! For our Medical Device Validation Handbook release party and networking reception immediately following the conclusion of Day One.

DAY TWO Wednesday, March 14, 2018

8:00

Continental Breakfast

8:10

Chairperson’s Review of Day One

Ivonne del C. Ramos Miranda
Senior Validation Manager
Medtronic

8:15

EYE-OPENER BREAKFAST DISCUSSION Develop Effective Strategies for Gap Analysis and Remediation Processes

Ivonne del C. Ramos Miranda
Senior Validation Manager
Medtronic

9:00

Discuss Key Considerations in Cleaning Validation

Clayton W. Foutch
Vice President of Sales
Foamtec

9:45

FDA Town Hall

This interactive session allows attendees to discuss pressing issues in validation and verification directly with those that regulate medical devices. All conference attendees will have the opportunity to submit questions in advance for the FDA to discuss during this Town Hall Exchange.

LEADERS:

CAPT Kim Lewandowski-Walker
National Expert, Medical Devices, Office of Regulatory Affairs
U.S. FDA

Adam E. Saltman, MD, PhD, FACS, FACC, FACP, FAHA
Medical Officer, CDRH Office of Compliance
U.S. FDA

11:00 – 12:30

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

SESSION 1 (Skills Lab)
Utilize Risk to Optimize V&V Sampling Plans

I. Define Sampling Plan methods and Techniques

II. Examine Confidence and Reliability levels

III. Explore Different Models

IV. Distribution-Fitting for Variables Plans

V. Distribution-Free Methods

Roberta Goode
Principal
Altrec, LLC

SESSION 2 Mitigation Controls for Medical Device Cybersecurity Vulnerabilities & Risks

I. An Overview of Cybersecurity in Medical Devices

II. Cybersecurity Vulnerabilities

III. FDA Expectations and Recommendations

IV. Cybersecurity Risk Management – Mitigation and Controls

V. Interactive Activity

Mahesh Tangella
President & CEO
BioQuality Inc.

12:30

Networking Luncheon

1:30 – 3:00

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

SESSION 3 Navigate the Complex V&V Landscape for Diagnostics

I. Define Verification and Validation

II. Understand What the FDA Wants

III. Explore How V&V Fits Into The Overall Process and Principals of Design Control

IV. Review Examples of FDA Warning Letters

Daniel Egeland, PhD
Senior Quality Assurance Professional, Design Quality Assurance
Abbott

SESSION 4 Process Characterization Using the Taguchi Method

I. Background in Robust Design

II. Analyzing Output

III. Where Does Taguchi Fit in the Toolkit?

IV. Interactive Exercise

Matt Hedrick
External Manufacturing & Supply Quality Manager
Cordis

3:00

Networking and Refreshment Break

3:30 – 5:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (5-6)

SESSION 5 Implement an Effective Master Validation Plan (MVP)

I. Review types of MVP

II. Define the Meaning and Intended Use of an MVP

III. Develop an MVP

Camille Guzman
Principle Quality Engineer
Medtronic

SESSION 6 Senior-Level Think Tank Examine Current Challenges in the Medical Device Industry

In this closed-door session, senior-level validation and quality professionals engage in open discussions with colleagues about creative strategies for achieving compliant validation in tricky situations (e.g., legacy processes, enforcement actions, acquisitions etc.). The content for this think tank is driven by participants, who are surveyed ahead of time about the details of the topic. The session is open to the first 15 senior-level professionals who preregister 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 medical device company. IVT reserves the right to qualify participants for this workshop.

THINK TANK LEADER:

Roberta Goode
Principal
Altrec, LLC

5:00

Close of Day Two

DAY THREE THURSDAY, MARCH 15, 2018

8:00

Continental Breakfast

8:10

Chairperson’s Review of Day Two

Ivonne del C. Ramos Miranda
Senior Validation Manager
Medtronic

Eye-Opener Breakfast Discussion Implement a
Validation Training Program

I. Validation Training Program Definition

II. Determining Training Program Effectiveness and Maintenance

Michael Zosel
Principal Training Developer
Medtronic

9:00 – 10:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (7-8)

SESSION 7 Tackle Risk Management in Change Control

I. Understand What Risk Management Is as It Relates to Change Control

II. Introduce Changes Driven by Risk

III. Implement Risk Management into the Process

IV. Review Examples of FDA Warning Letters

Daniel Egeland, PhD
Senior Quality Assurance Professional, Design Quality Assurance
Abbott

SESSION 8 Explore Testing Applications in Computer System Validation (CSV)

I. Key Characteristics of CSV

II. Examine Common Pitfalls in Testing and Validation

III. Review Paper-Based Testing and Application-Based Testing Methods

IV. Maintain the Validated State for a Validated Application

V. Improve Regulatory Compliance in CSV

VI. Interactive Activity

Christopher Van Hoof
Senior Software Validation Engineer
Abbott

10:30

Networking and Refreshment Break

11:00 – 12:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (9-10)

SESSION 9 Leverage Key Strategies to Conduct a Lean Validation

I. Fundamental Principles of Validation

II. Establishing an Effective Validated State

III. Challenges to Lean Validation

IV. Characterization

V. Techniques

VI. Revalidation

Tim Carr
Staff Quality Engineer
Abbott – Tendyne

SESSION 10 Build a Strategic Plan for Facilities Validation

I. Facilities Validations Overview

II. Types of Facilities Validations

III. Executing and Documenting Facilities Validations

IV. Q&A — Lessons Learned

Mauricio Chinchilla Romero
Senior Engineer, Quality
Edwards Lifesciences Costa Rica

12:30

Networking Luncheon

1:30 – 3:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (11-12)

SESSION 11 Tackle the Complexities of Supplier Partnerships in Validation

I. Explore Key Aspects of Successful Partnership Management

II. Develop Comprehensive Validation and Quality Monitoring Plans

III. Define Contingency Plans — What to Do When Things Go Wrong

IV. Interactive Activity

William Knab
Principal
Matrix Technology Management

SESSION 12 Explore Best Practices and Lessons Learned for Design Validation of Medical Devices

I. How to avoid restarting a 2 year long development with 100+ team members

II. Interactive Exercise

Miklos Szoke
Verification and Validation Program Manager
GE Healthcare

3:00 – 4:00

CLOSING SESSION

Navigate Risk Management Throughout Product Development

Risk is viewed as one of many requirements in a regulated industry that stands in the way of progress, particularly during the early stages of product development, when knowledge is limited and uncertainty – as well as risk – are correspondingly high. A fundamental question facing practitioners in highly regulated but rapidly changing industry such as the medical device industry is; Is innovation more likely or less likely if all stakeholders have considered risk?

Daniel L. Mooradian, PhD
Honeywell/James J. Renier Chair in Technology Management
Technological Leadership Institute (TLI), University of Minnesota

4:00

Close of Conference

Agenda

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

DAY ONE TUESDAY, MARCH 13, 2018

7:30

Conference Registration and Continental Breakfast

8:30

Workshop Leaders' Opening Remarks

CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS

WORKSHOP A Statistics in Validation Bootcamp

I. Learn the Process Capability Statistical Approach for Validation

II. Leverage Statistical Techniques From Process Validation for Design Verification

III. How to Choose Sample Sizes for Variables and Attributes Data

IV. Correlating Risk to Sample Size

V. Ansi Asq Z1.4 and Z1.9 Sampling Plans

VI. Hypothesis Testing and P-Values

WORKSHOP LEADER:

Roberta Goode
Principal
Altrec, LLC

WORKSHOP B Build Strategies and Implementation Plans for Test Method Validation (TMV)

I. TMV Overview

II. Tests vs. Test Methods

III. Strategies for Characterizing Tests for Use

IV. Validating Physical Test Methods

V. Validating Analytical Test Methods

WORKSHOP LEADER:

Tim Carr
Staff Quality Engineer
Abbott – Tendyne

*There will be a 30 minute networking and refreshment break at 10:00

12:00

Close of Workshop; Main Conference Registration

1:00

Chairperson’s Welcome and Opening Remarks

Ivonne del C. Ramos Miranda
Senior Validation Manager
Medtronic

Crucial Regulatory Updates for Medical Devices

1:15

Reevaluate Risk — The Case for Benefit Analysis in Validation

Adam E. Saltman, MD, PhD, FACS
Medical Officer, CDRH Office of Compliance
U.S. FDA

2:00

The FDA’s Case for Quality —
Promoting Organizational Excellence, Collaboration and Simplification

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

2:45

Review Updates in the Medical Device Single Audit Program (MDSAP)

CAPT Kim Lewandowski-Walker
National Expert, Medical Devices, Office of Regulatory Affairs
U.S. FDA

3:30

Networking and Refreshment Break

4:00

Examine the Practical Impact to Medical Device Manufacturers of the Evolving Global Regulatory Landscape (ISO 13485:2016, MDR, MEDDEV)

Donald Henderson
Senior Regulatory and Quality Consultant, ISO/MDR Transition Team
Johnson & Johnson’s Global Surgery Enterprise

4:45

Medical Device Validation Handbook — Ask the Authors Panel

Roberta Goode
Principal
Altrec, LLC

Matt Hedrick
External Manufacturing & Supply Quality Manager
Cordis

Ivonne del C. Ramos Miranda
Senior Validation Manager
Medtronic

William Knab
Principal
Matrix Technology Management

5:30

Close of Day One

PLEASE JOIN US! For our Medical Device Validation Handbook release party and networking reception immediately following the conclusion of Day One.

DAY TWO Wednesday, March 14, 2018

8:00

Continental Breakfast

8:10

Chairperson’s Review of Day One

Ivonne del C. Ramos Miranda
Senior Validation Manager
Medtronic

8:15

EYE-OPENER BREAKFAST DISCUSSION Develop Effective Strategies for Gap Analysis and Remediation Processes

Ivonne del C. Ramos Miranda
Senior Validation Manager
Medtronic

9:00

Discuss Key Considerations in Cleaning Validation

Clayton W. Foutch
Vice President of Sales
Foamtec

9:45

FDA Town Hall

This interactive session allows attendees to discuss pressing issues in validation and verification directly with those that regulate medical devices. All conference attendees will have the opportunity to submit questions in advance for the FDA to discuss during this Town Hall Exchange.

LEADERS:

CAPT Kim Lewandowski-Walker
National Expert, Medical Devices, Office of Regulatory Affairs
U.S. FDA

Adam E. Saltman, MD, PhD, FACS, FACC, FACP, FAHA
Medical Officer, CDRH Office of Compliance
U.S. FDA

11:00 – 12:30

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

SESSION 1 (Skills Lab)
Utilize Risk to Optimize V&V Sampling Plans

I. Define Sampling Plan methods and Techniques

II. Examine Confidence and Reliability levels

III. Explore Different Models

IV. Distribution-Fitting for Variables Plans

V. Distribution-Free Methods

Roberta Goode
Principal
Altrec, LLC

SESSION 2 Mitigation Controls for Medical Device Cybersecurity Vulnerabilities & Risks

I. An Overview of Cybersecurity in Medical Devices

II. Cybersecurity Vulnerabilities

III. FDA Expectations and Recommendations

IV. Cybersecurity Risk Management – Mitigation and Controls

V. Interactive Activity

Mahesh Tangella
President & CEO
BioQuality Inc.

12:30

Networking Luncheon

1:30 – 3:00

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

SESSION 3 Navigate the Complex V&V Landscape for Diagnostics

I. Define Verification and Validation

II. Understand What the FDA Wants

III. Explore How V&V Fits Into The Overall Process and Principals of Design Control

IV. Review Examples of FDA Warning Letters

Daniel Egeland, PhD
Senior Quality Assurance Professional, Design Quality Assurance
Abbott

SESSION 4 Process Characterization Using the Taguchi Method

I. Background in Robust Design

II. Analyzing Output

III. Where Does Taguchi Fit in the Toolkit?

IV. Interactive Exercise

Matt Hedrick
External Manufacturing & Supply Quality Manager
Cordis

3:00

Networking and Refreshment Break

3:30 – 5:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (5-6)

SESSION 5 Implement an Effective Master Validation Plan (MVP)

I. Review types of MVP

II. Define the Meaning and Intended Use of an MVP

III. Develop an MVP

Camille Guzman
Principle Quality Engineer
Medtronic

SESSION 6 Senior-Level Think Tank Examine Current Challenges in the Medical Device Industry

In this closed-door session, senior-level validation and quality professionals engage in open discussions with colleagues about creative strategies for achieving compliant validation in tricky situations (e.g., legacy processes, enforcement actions, acquisitions etc.). The content for this think tank is driven by participants, who are surveyed ahead of time about the details of the topic. The session is open to the first 15 senior-level professionals who preregister 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 medical device company. IVT reserves the right to qualify participants for this workshop.

THINK TANK LEADER:

Roberta Goode
Principal
Altrec, LLC

5:00

Close of Day Two

DAY THREE THURSDAY, MARCH 15, 2018

8:00

Continental Breakfast

8:10

Chairperson’s Review of Day Two

Ivonne del C. Ramos Miranda
Senior Validation Manager
Medtronic

Eye-Opener Breakfast Discussion Implement a
Validation Training Program

I. Validation Training Program Definition

II. Determining Training Program Effectiveness and Maintenance

Michael Zosel
Principal Training Developer
Medtronic

9:00 – 10:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (7-8)

SESSION 7 Tackle Risk Management in Change Control

I. Understand What Risk Management Is as It Relates to Change Control

II. Introduce Changes Driven by Risk

III. Implement Risk Management into the Process

IV. Review Examples of FDA Warning Letters

Daniel Egeland, PhD
Senior Quality Assurance Professional, Design Quality Assurance
Abbott

SESSION 8 Explore Testing Applications in Computer System Validation (CSV)

I. Key Characteristics of CSV

II. Examine Common Pitfalls in Testing and Validation

III. Review Paper-Based Testing and Application-Based Testing Methods

IV. Maintain the Validated State for a Validated Application

V. Improve Regulatory Compliance in CSV

VI. Interactive Activity

Christopher Van Hoof
Senior Software Validation Engineer
Abbott

10:30

Networking and Refreshment Break

11:00 – 12:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (9-10)

SESSION 9 Leverage Key Strategies to Conduct a Lean Validation

I. Fundamental Principles of Validation

II. Establishing an Effective Validated State

III. Challenges to Lean Validation

IV. Characterization

V. Techniques

VI. Revalidation

Tim Carr
Staff Quality Engineer
Abbott – Tendyne

SESSION 10 Build a Strategic Plan for Facilities Validation

I. Facilities Validations Overview

II. Types of Facilities Validations

III. Executing and Documenting Facilities Validations

IV. Q&A — Lessons Learned

Mauricio Chinchilla Romero
Senior Engineer, Quality
Edwards Lifesciences Costa Rica

12:30

Networking Luncheon

1:30 – 3:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (11-12)

SESSION 11 Tackle the Complexities of Supplier Partnerships in Validation

I. Explore Key Aspects of Successful Partnership Management

II. Develop Comprehensive Validation and Quality Monitoring Plans

III. Define Contingency Plans — What to Do When Things Go Wrong

IV. Interactive Activity

William Knab
Principal
Matrix Technology Management

SESSION 12 Explore Best Practices and Lessons Learned for Design Validation of Medical Devices

I. How to avoid restarting a 2 year long development with 100+ team members

II. Interactive Exercise

Miklos Szoke
Verification and Validation Program Manager
GE Healthcare

3:00 – 4:00

CLOSING SESSION

Navigate Risk Management Throughout Product Development

Risk is viewed as one of many requirements in a regulated industry that stands in the way of progress, particularly during the early stages of product development, when knowledge is limited and uncertainty – as well as risk – are correspondingly high. A fundamental question facing practitioners in highly regulated but rapidly changing industry such as the medical device industry is; Is innovation more likely or less likely if all stakeholders have considered risk?

Daniel L. Mooradian, PhD
Honeywell/James J. Renier Chair in Technology Management
Technological Leadership Institute (TLI), University of Minnesota

4:00

Close of Conference