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Agenda

The Premier Validation Event for Medical Device and Diagnostics

March 12-14, 2019
  • Minneapolis, MN

Agenda

Want more agenda details? Download the brochure.

DAY ONE Tuesday, March 12, 2019

12:00

Conference Registration

1:00

Chairman’s Welcome and Opening Remarks

Tim Carr
Staff Quality Engineer
Abbott

Critical Regulatory Developments Affecting QMS and V&V

1:15

KEYNOTE ADDRESS Explore Validation of Digital Therapeutics

David Amor, MS
Vice President, Quality and Regulatory
Pear Therapeutics, Inc.

2:15

GAME CHANGER! Update on FDA and Industry Collaboration on Computer Software Assurance

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

Francesca Bill
IT Manager, Quality Assurance Governance
Medtronic

3:15

Networking and Refreshment Break

3:45

Quality Management Systems (QMS) Implications of EU MDR

Kimberly A. Trautman, MS
Executive Vice President, Medical Device International Services
NSF Medical Devices

4:30

EU MDR —
Understanding the Impact and Developing an Implementation Strategy

Donald Henderson, BS
President
Henderson Quality and Compliance Consulting

5:15

Close of Day One

Networking,
Wine and Cheese
Reception
immediately following the final session on day one

DAY TWO Wednesday, March 13, 2019

8:00

Continental Breakfast and Chairman’s Opening Remarks

Tim Carr
Staff Quality Engineer
Abbott

8:30

Discuss Key Challenges in Data Integrity and Technical Systems Qualification

I. Understanding Data and Data Integrity

II. Data Integrity Considerations During Project Scoping

III. Write the System URS

IV. Configure System

V. Qualification

VI. Ongoing Maintenance

Tim Carr
Staff Quality Engineer
Abbott

10:00

Networking and Refreshment Break

10:30 – 11:30

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

SESSION 1 Good, Cheap AND Fast — Project Management Methods for Validation Success

Validation projects are often subject to pressure to be completed with fixed resources and as quickly as possible, all while maintaining validity and audit robustness. Gantt charts are most commonly used but are seldom robust enough to meet the “game-time” changing events that often come up throughout the project. A more comprehensive approach is required.

In this session, gain a combination of methods and tools that has proven to deliver project excellence time and time again.

Anthony Carra, MBB, PMP
Owner and Principal Consultant
Business Improvement Group Consulting, LLC

SESSION 2 Enhance Documentation Practices and Knowledge Management in V&V Activities

This session provides an overview of Medical Device V&V requirements from an on-the-ground quality management perspective, including consideration of best practices to be followed when writing and executing protocols, along with associated methodologies to ensure that equipment and processes remain in a proactively validated state. Communication strategies are also reviewed to ensure that key personnel are kept in the loop as protocol changes are implemented.

I. Overview of Validation and Verification Requirements

II. Understand What Should be Documented in Test Protocols and Reports

III. Knowledge Management as it pertains to V&V Activities

IV. Case Studies

Daniel Shertok
Director of Quality
Osprey Medical

11:30 – 12:30

CHOOSE BETWEEN TWO 60-MINUTE SESSIONS (3-4)

SESSION 3 Develop Effective Tools and Tactics for
Root Cause Analysis

I. Root Cause

II. Overview of Root Cause Tools

III. Review the Quality System

IV. Investigate

V. What to Do After the RCA

Tim Carr
Staff Quality Engineer
Abbott

SESSION 4 Explore the Journey from Warning Letter
to Integration

Jim Broge
Director, Quality Systems
Boston Scientific

12:30

Networking Luncheon

1:30 – 3:00

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

SESSION 5 Senior Level Think Tank —
Challenges & Best Practices for Incorporating Risk Management in V&V Activities

In this closed-door session, senior-level validation and quality professionals engage in open discussions with colleagues about challenges and best practices for incorporating risk management into verification and validation activities. The detailed content for this topic is driven by participants, who are surveyed ahead of time about their own challenges and solutions in risk management within verification and validation. 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.

Roberta D. Goode, MSBE, CQE
Technical Trainer
Altrec, LLC

SESSION 6 A Roadmap to Implantable Medical Device Cleanliness Validation

I. Device Cleanliness: Learning to Think Differently

II. Definitions

III. Regulatory Trends

IV. Validation Lifecycle

V. Device Cleanliness Reference Documents / Cleanliness Validation Resources

VI. Industry Known Cleanliness Testing Laboratories

VII. Workshop

Denise Paone
Manager QA, Validation Engineering, ASQ: CQE, CMQ/OE and CQA
Exactech, Inc.

3:00

Networking and Refreshment Break

3:30 – 5:00

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

SESSION 7 Address Common Challenges in Test Method Validation (TMV)

I. Test Method Validation Requirements

II. Test Method Validation

III. Review Template for Test Method Validation Protocol and Final Report

IV. Interactive Session —
Dealing with Out-of-Spec (OOS) Test Result From a Validated Test Method

Meena Chettiar
Principal Design Assurance Engineer
Freudenberg Medical

SESSION 8 Statistics for Non-Statisticians — Sampling Plans for Verification and Validation

The practical and compliant use of statistical techniques in validation and verification is among the leading challenges cited by life science professionals. What sample sizes are adequate? How do we incorporate risk into validation practices? What are auditors looking for? In this interactive session, explore strategies for risk-based selection of sampling plans for verification and validation, including attributes and variables sampling, reliability estimates, and balancing consumer and producer risk.

Roberta D. Goode, MSBE, CQE
Technical Trainer
Altrec, LLC

5:00

Close of Day Two

DAY THREE Thursday, March 14, 2019

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One & Two

Tim Carr
Staff Quality Engineer
Abbott

8:45

Effective Strategies for Managing Risk Throughout the Product Lifecycle

Jennifer Zuba
Design Control, Risk Management, & Usability Process Owner
W.L. Gore & Associates

9:30

Ensure Effective Integration and Harmonization of Quality Systems in M&A

Roberta D. Goode, MSBE, CQE
Technical Trainer
Altrec, LLC

10:15

Networking and Refreshment Break

10:45

ROUNDTABLE DISCUSSION BRING YOUR OWN CHALLENGE

During this unique workshop, attendees benefit from an opportunity to share their greatest pain points and collaborate with peers and speakers in small groups to develop strategies for managing their most pressing challenges. The content for the session is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

We encourage you to bring any unique challenges you are currently facing to be worked through during this real-life, discussion-driven session to brainstorm take-home solutions.

Anthony Carra, MBB, PMP
Owner and Principal Consultant
Business Improvement Group Consulting, LLC

11:30

Explore Challenges in Design for Manufacture and Assembly (DFMA)

Asmita Khanolkar
Director, Device Manufacturing
Semma Therapeutics

12:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE Tuesday, March 12, 2019

12:00

Conference Registration

1:00

Chairman’s Welcome and Opening Remarks

Tim Carr
Staff Quality Engineer
Abbott

Critical Regulatory Developments Affecting QMS and V&V

1:15

KEYNOTE ADDRESS Explore Validation of Digital Therapeutics

David Amor, MS
Vice President, Quality and Regulatory
Pear Therapeutics, Inc.

2:15

GAME CHANGER! Update on FDA and Industry Collaboration on Computer Software Assurance

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

Francesca Bill
IT Manager, Quality Assurance Governance
Medtronic

3:15

Networking and Refreshment Break

3:45

Quality Management Systems (QMS) Implications of EU MDR

Kimberly A. Trautman, MS
Executive Vice President, Medical Device International Services
NSF Medical Devices

4:30

EU MDR —
Understanding the Impact and Developing an Implementation Strategy

Donald Henderson, BS
President
Henderson Quality and Compliance Consulting

5:15

Close of Day One

Networking,
Wine and Cheese
Reception
immediately following the final session on day one

DAY TWO Wednesday, March 13, 2019

8:00

Continental Breakfast and Chairman’s Opening Remarks

Tim Carr
Staff Quality Engineer
Abbott

8:30

Discuss Key Challenges in Data Integrity and Technical Systems Qualification

I. Understanding Data and Data Integrity

II. Data Integrity Considerations During Project Scoping

III. Write the System URS

IV. Configure System

V. Qualification

VI. Ongoing Maintenance

Tim Carr
Staff Quality Engineer
Abbott

10:00

Networking and Refreshment Break

10:30 – 11:30

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

SESSION 1 Good, Cheap AND Fast — Project Management Methods for Validation Success

Validation projects are often subject to pressure to be completed with fixed resources and as quickly as possible, all while maintaining validity and audit robustness. Gantt charts are most commonly used but are seldom robust enough to meet the “game-time” changing events that often come up throughout the project. A more comprehensive approach is required.

In this session, gain a combination of methods and tools that has proven to deliver project excellence time and time again.

Anthony Carra, MBB, PMP
Owner and Principal Consultant
Business Improvement Group Consulting, LLC

SESSION 2 Enhance Documentation Practices and Knowledge Management in V&V Activities

This session provides an overview of Medical Device V&V requirements from an on-the-ground quality management perspective, including consideration of best practices to be followed when writing and executing protocols, along with associated methodologies to ensure that equipment and processes remain in a proactively validated state. Communication strategies are also reviewed to ensure that key personnel are kept in the loop as protocol changes are implemented.

I. Overview of Validation and Verification Requirements

II. Understand What Should be Documented in Test Protocols and Reports

III. Knowledge Management as it pertains to V&V Activities

IV. Case Studies

Daniel Shertok
Director of Quality
Osprey Medical

11:30 – 12:30

CHOOSE BETWEEN TWO 60-MINUTE SESSIONS (3-4)

SESSION 3 Develop Effective Tools and Tactics for
Root Cause Analysis

I. Root Cause

II. Overview of Root Cause Tools

III. Review the Quality System

IV. Investigate

V. What to Do After the RCA

Tim Carr
Staff Quality Engineer
Abbott

SESSION 4 Explore the Journey from Warning Letter
to Integration

Jim Broge
Director, Quality Systems
Boston Scientific

12:30

Networking Luncheon

1:30 – 3:00

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

SESSION 5 Senior Level Think Tank —
Challenges & Best Practices for Incorporating Risk Management in V&V Activities

In this closed-door session, senior-level validation and quality professionals engage in open discussions with colleagues about challenges and best practices for incorporating risk management into verification and validation activities. The detailed content for this topic is driven by participants, who are surveyed ahead of time about their own challenges and solutions in risk management within verification and validation. 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.

Roberta D. Goode, MSBE, CQE
Technical Trainer
Altrec, LLC

SESSION 6 A Roadmap to Implantable Medical Device Cleanliness Validation

I. Device Cleanliness: Learning to Think Differently

II. Definitions

III. Regulatory Trends

IV. Validation Lifecycle

V. Device Cleanliness Reference Documents / Cleanliness Validation Resources

VI. Industry Known Cleanliness Testing Laboratories

VII. Workshop

Denise Paone
Manager QA, Validation Engineering, ASQ: CQE, CMQ/OE and CQA
Exactech, Inc.

3:00

Networking and Refreshment Break

3:30 – 5:00

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

SESSION 7 Address Common Challenges in Test Method Validation (TMV)

I. Test Method Validation Requirements

II. Test Method Validation

III. Review Template for Test Method Validation Protocol and Final Report

IV. Interactive Session —
Dealing with Out-of-Spec (OOS) Test Result From a Validated Test Method

Meena Chettiar
Principal Design Assurance Engineer
Freudenberg Medical

SESSION 8 Statistics for Non-Statisticians — Sampling Plans for Verification and Validation

The practical and compliant use of statistical techniques in validation and verification is among the leading challenges cited by life science professionals. What sample sizes are adequate? How do we incorporate risk into validation practices? What are auditors looking for? In this interactive session, explore strategies for risk-based selection of sampling plans for verification and validation, including attributes and variables sampling, reliability estimates, and balancing consumer and producer risk.

Roberta D. Goode, MSBE, CQE
Technical Trainer
Altrec, LLC

5:00

Close of Day Two

DAY THREE Thursday, March 14, 2019

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One & Two

Tim Carr
Staff Quality Engineer
Abbott

8:45

Effective Strategies for Managing Risk Throughout the Product Lifecycle

Jennifer Zuba
Design Control, Risk Management, & Usability Process Owner
W.L. Gore & Associates

9:30

Ensure Effective Integration and Harmonization of Quality Systems in M&A

Roberta D. Goode, MSBE, CQE
Technical Trainer
Altrec, LLC

10:15

Networking and Refreshment Break

10:45

ROUNDTABLE DISCUSSION BRING YOUR OWN CHALLENGE

During this unique workshop, attendees benefit from an opportunity to share their greatest pain points and collaborate with peers and speakers in small groups to develop strategies for managing their most pressing challenges. The content for the session is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

We encourage you to bring any unique challenges you are currently facing to be worked through during this real-life, discussion-driven session to brainstorm take-home solutions.

Anthony Carra, MBB, PMP
Owner and Principal Consultant
Business Improvement Group Consulting, LLC

11:30

Explore Challenges in Design for Manufacture and Assembly (DFMA)

Asmita Khanolkar
Director, Device Manufacturing
Semma Therapeutics

12:15

Close of Conference