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Agenda

Recent Enforcement Updates • Risk-based Decision Making • Navigation of Global Requirements

September 16-18, 2019
  • Silver Spring, MD

Agenda

Want more agenda details? Download the brochure.
Product Quality Complaints Management Seminar

12:00

Summit Registration and Lunch

1:00

Summit Leader’s Welcome and Opening Remarks

1:20

PANEL Industry Best Practices for Quality Compliant Management

MODERATOR:

Darin Oppenheimer
Executive Director, Drug-Device Center of Excellence
Merck

PANELISTS:

Larry Perruzza, MSc, RAC
Director, Product Quality Vigilance - Combination Products NA/LATAM
Janssen Pharmaceuticals

Edgardo Colon
Product Complaint Process Owner
Amgen

Lea Ngar Tan
Global System Owner for Product Complaints, Alert and Recalls
EMD Serono

2:20

Networking and Refreshment Break

3:00

FDA Regulatory Update

Steven Niedelman
Lead Quality System and Compliance Consultant
King and Spalding

3:45

Closing Conversation and Discussion on Trend Analytics and Solutions

4:30

Close of Seminar and Wine and Cheese Networking

DAY ONE | TUESDAY, SEPTEMBER 17, 2019

7:30

Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

George Cusatis
Associate Director Device & Digital Health
Merck

8:45

FDA KEYNOTE ADDRESS Recalls — Past, Present and Future

Erik P. Mettler
Assistant Commissioner, MPA, MPH, ORA
FDA

9:45

Examine FDA Local Coordination Requirements to Effectively Work with Industry

Cecilia Wolyniak
Lead Consumer Safety Officer, ORA
FDA

Dyana Stone
Consumer Safety Officer, ORA
FDA

10:30

Networking and Refreshment Break

11:00

Recall Prevention —
Using the QMS to Prevent Recalls and Enable Successful Management

Patrick Caines, PhD
Senior Director, Quality & Compliance
Baxter Healthcare

11:45

Consumer Feedback — Processes, Issues and Streamlining

MODERATOR:

Geetha Rao
CEO
Springborne Life Sciences

PANELISTS:

George Cusatis
Associate Director Device & Digital Health
Merck

Patrick Caines, PhD
Senior Director, Quality & Compliance
Baxter Healthcare

12:30

Networking Luncheon

1:15

ROUNDTABLE DISCUSSION Critical Thinking Processes to Conduct Health Hazard Evaluations (HHE)

Beverly Lorell, MD, FACC
Senior Medical and Policy Advisor, FDA Life Sciences Group
King & Spalding LLP

Kevin Escapule
Director, Post Market Surveillance
Zimmer Biomet

Thomas Morrissey, MD
Vice President, Product Safety
Edwards Lifesciences

2:00

CASE STUDIES Mitigate Risk to Avoid Field Corrections and Recalls

George Cusatis
Associate Director, Device & Digital Health
Merck

2:45

Networking and Refreshment Break

3:15

Transforming to a Digital Recalls Network — A Review of the Current 2019 FDA DSCSA Digital Recalls Pilot Program

Brian Daleiden
VP Industry Marketing/Community and Co-Founder
TraceLink

4:00

EXTENDED SESSION Post-Market Risk Monitoring for Digital Medical Devices

Geetha Rao
CEO
Springborne Life Sciences

Sandy Weininger
Senior Electrical/Biomedical Engineer
FDA

5:30

Close of Day One

JOIN US! Networking Reception immediately following final session

DAY TWO | Wednesday, September 18, 2019

8:00

Continental Breakfast

8:30

Chairman’s Review of Day One

George Cusatis
Associate Director, Device & Digital Health
Merck

8:45

Successful Recall Strategies to Ensure Compliance with Global Regulations and FDA Protocols

Doris M. Apel, JD, RAC
Manager, Regulatory Affairs
Varian Medical Systems, Inc.

9:30

CHOOSE BETWEEN TWO 45-MINUTE LEARNING LABS (1-2) Learning labs provide multi-stakeholder perspectives in order to derive insights and
an all-encompassing view of end-to-end recall execution.

COMBINATION PRODUCTS

1 Strategic Approach to Executing a Recall

Stine Jacobsen
Senior Complaint and Recall Advisor
Novo Nordisk A/S

Christina Wøhlk Nielsen
Complaint and Recall Advisor
Novo Nordisk A/S

MEDICAL DEVICES

2 GS1 Standards Applied to Supply Chain or UDI

Beth Wells
Senior Director, Community Engagement
GS1 US

10:15

Networking and Refreshment Break

10:45

CHOOSE BETWEEN TWO 45-MINUTE LEARNING LABS (3-4)

HEALTH SYSTEMS

3 Hospital Recall Practices

NiCole Head
Buy to Pay, National Product Safety & Recall –
Demand Planning & Inventory Management
Kaiser Permanente

MEDICAL DEVICES

4 Regulatory Dynamics in Risk Management and
its Impact on Recalls Decision Making

Darin Oppenheimer
Executive Director, Drug-Device Center of Excellence
Merck

11:30

Networking Luncheon

12:30

CHOOSE BETWEEN TWO 45-MINUTE LEARNING LABS (5-6)

MEDICAL DEVICES

5 Handling Post-Market Design Changes to Software-Centric Devices

Eric Henry
Senior Quality Systems & Compliance Consultant, FDA and Life Sciences Practice
King & Spalding

PHARMACEUTICAL

6 How to Avoid Packaging and Mislabeling Errors

Hernan Gonzalez
Manager, External Supply
Pfizer

1:15

FDA Town Hall Exchange

Cecilia Wolyniak
Lead Consumer Safety Officer, ORA
FDA

Ileana Elder, PhD
Branch Chief, Recalls and Shortages Branch
CDER|FDA

2:15

End of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.
Product Quality Complaints Management Seminar

12:00

Summit Registration and Lunch

1:00

Summit Leader’s Welcome and Opening Remarks

1:20

PANEL Industry Best Practices for Quality Compliant Management

MODERATOR:

Darin Oppenheimer
Executive Director, Drug-Device Center of Excellence
Merck

PANELISTS:

Larry Perruzza, MSc, RAC
Director, Product Quality Vigilance - Combination Products NA/LATAM
Janssen Pharmaceuticals

Edgardo Colon
Product Complaint Process Owner
Amgen

Lea Ngar Tan
Global System Owner for Product Complaints, Alert and Recalls
EMD Serono

2:20

Networking and Refreshment Break

3:00

FDA Regulatory Update

Steven Niedelman
Lead Quality System and Compliance Consultant
King and Spalding

3:45

Closing Conversation and Discussion on Trend Analytics and Solutions

4:30

Close of Seminar and Wine and Cheese Networking

DAY ONE | TUESDAY, SEPTEMBER 17, 2019

7:30

Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

George Cusatis
Associate Director Device & Digital Health
Merck

8:45

FDA KEYNOTE ADDRESS Recalls — Past, Present and Future

Erik P. Mettler
Assistant Commissioner, MPA, MPH, ORA
FDA

9:45

Examine FDA Local Coordination Requirements to Effectively Work with Industry

Cecilia Wolyniak
Lead Consumer Safety Officer, ORA
FDA

Dyana Stone
Consumer Safety Officer, ORA
FDA

10:30

Networking and Refreshment Break

11:00

Recall Prevention —
Using the QMS to Prevent Recalls and Enable Successful Management

Patrick Caines, PhD
Senior Director, Quality & Compliance
Baxter Healthcare

11:45

Consumer Feedback — Processes, Issues and Streamlining

MODERATOR:

Geetha Rao
CEO
Springborne Life Sciences

PANELISTS:

George Cusatis
Associate Director Device & Digital Health
Merck

Patrick Caines, PhD
Senior Director, Quality & Compliance
Baxter Healthcare

12:30

Networking Luncheon

1:15

ROUNDTABLE DISCUSSION Critical Thinking Processes to Conduct Health Hazard Evaluations (HHE)

Beverly Lorell, MD, FACC
Senior Medical and Policy Advisor, FDA Life Sciences Group
King & Spalding LLP

Kevin Escapule
Director, Post Market Surveillance
Zimmer Biomet

Thomas Morrissey, MD
Vice President, Product Safety
Edwards Lifesciences

2:00

CASE STUDIES Mitigate Risk to Avoid Field Corrections and Recalls

George Cusatis
Associate Director, Device & Digital Health
Merck

2:45

Networking and Refreshment Break

3:15

Transforming to a Digital Recalls Network — A Review of the Current 2019 FDA DSCSA Digital Recalls Pilot Program

Brian Daleiden
VP Industry Marketing/Community and Co-Founder
TraceLink

4:00

EXTENDED SESSION Post-Market Risk Monitoring for Digital Medical Devices

Geetha Rao
CEO
Springborne Life Sciences

Sandy Weininger
Senior Electrical/Biomedical Engineer
FDA

5:30

Close of Day One

JOIN US! Networking Reception immediately following final session

DAY TWO | Wednesday, September 18, 2019

8:00

Continental Breakfast

8:30

Chairman’s Review of Day One

George Cusatis
Associate Director, Device & Digital Health
Merck

8:45

Successful Recall Strategies to Ensure Compliance with Global Regulations and FDA Protocols

Doris M. Apel, JD, RAC
Manager, Regulatory Affairs
Varian Medical Systems, Inc.

9:30

CHOOSE BETWEEN TWO 45-MINUTE LEARNING LABS (1-2) Learning labs provide multi-stakeholder perspectives in order to derive insights and
an all-encompassing view of end-to-end recall execution.

COMBINATION PRODUCTS

1 Strategic Approach to Executing a Recall

Stine Jacobsen
Senior Complaint and Recall Advisor
Novo Nordisk A/S

Christina Wøhlk Nielsen
Complaint and Recall Advisor
Novo Nordisk A/S

MEDICAL DEVICES

2 GS1 Standards Applied to Supply Chain or UDI

Beth Wells
Senior Director, Community Engagement
GS1 US

10:15

Networking and Refreshment Break

10:45

CHOOSE BETWEEN TWO 45-MINUTE LEARNING LABS (3-4)

HEALTH SYSTEMS

3 Hospital Recall Practices

NiCole Head
Buy to Pay, National Product Safety & Recall –
Demand Planning & Inventory Management
Kaiser Permanente

MEDICAL DEVICES

4 Regulatory Dynamics in Risk Management and
its Impact on Recalls Decision Making

Darin Oppenheimer
Executive Director, Drug-Device Center of Excellence
Merck

11:30

Networking Luncheon

12:30

CHOOSE BETWEEN TWO 45-MINUTE LEARNING LABS (5-6)

MEDICAL DEVICES

5 Handling Post-Market Design Changes to Software-Centric Devices

Eric Henry
Senior Quality Systems & Compliance Consultant, FDA and Life Sciences Practice
King & Spalding

PHARMACEUTICAL

6 How to Avoid Packaging and Mislabeling Errors

Hernan Gonzalez
Manager, External Supply
Pfizer

1:15

FDA Town Hall Exchange

Cecilia Wolyniak
Lead Consumer Safety Officer, ORA
FDA

Ileana Elder, PhD
Branch Chief, Recalls and Shortages Branch
CDER|FDA

2:15

End of Conference