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Day One | Monday, September 25, 2017

12:15

Conference Registration

1:15

Chairperson’s Welcome and Opening Remarks

Pearley Bhambri
Senior Director, Global Quality Systems
Hill-Rom

1:30

FDA Regulatory Requirements, Expectations and Trends

Israel Santiago
Branch Chief, Recalls and Shortages Branch,
Office of Drug Security, Integrity and Recalls
CDER/Office of Compliance, FDA

2:15

CASE STUDIES Mobilize and Deploy a Field-Based Team During a Recall

Hillary Medina
Senior Director, Recall Solutions
Novasyte

3:00

Networking and Refreshment Break

3:30

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

1 Senior-Level Think Tank — Assessment Leading into a Recall

In this closed-door session, senior-level recall professionals engage in open discussions with colleagues on assessments leading into a recall. 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 seniorlevel professionals who pre-register for the interactive discussion group. To pre-register, you must have over five years of experience and currently work for a pharmaceutical, biotechnology or medical device company.

CBI reserves the right to qualify participants for this workshop.

Pearley Bhambri
Senior Director, Global Quality Systems
Hill-Rom

 
2 Recall Fundamentals and How to Improve Recall Strategies from Start to Finish

It is essential that teams understand effective methods and strategies to successfully manage a recall. Benefit from this in-depth session by learning how to improve recall strategies from start to finish.

Sonali Gunawardhana
Attorney at Law
Wiley Rein LLP

5:00

Close of Day One

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

Day Two | Tuesday, September 26, 2018

8:00

Case Study Breakfast Roundtable

Speakers and the CBI recalls community bring blind case studies to the table and talk them through as a group, identifying challenges faced and walking away with best practices.

8:45

Chairperson’s Review of Day One

Pearley Bhambri
Senior Director, Global Quality Systems
Hill-Rom

9:00

INTERACTIVE SESSION —
Execute a Mock Recall to Ensure Team Readiness

From the passage of the 21st Century Cures Act to increasing challenges with counterfeit drugs, the environment surrounding pharmaceutical regulations is constantly shifting. It is important for pharmaceutical companies to continually reevaluate their recall plans and regularly hold mock recalls to ensure rapid team response. During this interactive session, attendees break into collaborative working groups to execute a mock recall. Teams are provided with key information needed to analyze the severity of the issue and develop a strategy for every stage of the recall lifecycle, including consignee notifications, response management, product processing and close out with the FDA. The groups then come together to share lessons learned and identify techniques for increasing efficiency and effectiveness.

Exercise Outline:

I. Understand the Scope of the Issue

II. Develop a Recall Strategy

III. Collaborate with the FDA and Identify Regulatory Documentation Requirement

IV. Identify Consignees and Construct a Notification Plan

V. Execute a Mock Recall Exercise

VI. Terminate the Mock Recall and Assess Key Takeaways

Lessons Learned and Key Takeaways:

Attendees develop a better understanding of the full recall lifecycle and are able to identify potential gaps in their current plans.

Amanda Combs
Recall Consultant
Stericycle

Willie Bryant
Expert Consultant
Stericycle

Chris Harvey
Director, Recall Solutions
Stericycle

10:30

Networking and Refreshment Break

11:00

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

3 Drug Recalls — An Update with FDA

Join FDA and industry experts for a discussion on effective drug recalls. Learn from the opportunity to hear their diverse experiences with the recall process and lessons learned.

Israel Santiago
Branch Chief, Recalls and Shortages Branch,
Office of Drug Security, Integrity and Recalls
CDER/Office of Compliance, FDA

Ron Brown
Team Leader
CDER/Office of Compliance, FDA

 
4 Device Recalls — An Update with Industry and FDA

Benefit from a discussion between industry experts and the FDA on specific considerations for medical device recalls. This is an opportunity to hear from the FDA and industry stakeholders regarding best practices, regulatory standards and their roles in the recall process.

Maureen Bernier
Biomedical Engineer, Recall Coordinator,
CDRH, FDA Office of Compliance
DAPO, Recall Branch

Hal Baden
Recall Coordinator & Distribution Logistics QA
Cordis, A Cardinal Health Company

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

12:30

Networking Luncheon

1:30

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

5 Ensure Timely and Effective Recall Communication to Minimize the Impacts on Brand and Reputation

Communicating a recall to those involved internally and externally (consumers) greatly impacts the overall effectiveness of the recall. Communicating poorly results in dissatisfied customers and potential legal issues, which negatively affects your brand. This session focuses on best practices for proper targeted communication to relay timely, appropriate information that influences the overall outcome.

Maureen Bernier
Biomedical Engineer, Recall Coordinator,
CDRH, FDA Office of Compliance
DAPO, Recall Branch

 
6 Make Proper Decisions About Initiating a Recall

This session focuses on the recall decision-making process and thought process of those involved when determining to conduct a recall.

Nina Mezu-Nwaba, PharmD, MPH, MSc, CAPT
United States Public Health Service, Senior Scientific Reviewer
CDRH/OC/DMQ/FDA

Ron Brown
Team Leader
CDER/Office of Compliance, FDA

3:00

Networking and Refreshment Break

3:30

Implement Successful Execution Strategies for Voluntary Recalls

Lavinia Marinescu-Pedersen
Senior Product Defects and Recalls Advisor, Customer Complaint Center
Novo Nordisk

4:15

Close of Day Two

Day Three | Wednesday, September 27, 2017

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day Two

Pearley Bhambri
Senior Director, Global Quality Systems
Hill-Rom

8:45

Best Practices to Prepare for Audits and Inspections

Maureen Bernier
Biomedical Engineer, Recall Coordinator,
CDRH, FDA Office of Compliance
DAPO, Recall Branch

9:30

How to Build a Globally Integrated Recall Process

Pearley Bhambri
Senior Director, Global Quality Systems
Hill-Rom

Jeffrey Moster
Director, Post Market Surveillance
Hill-Rom

10:15

Networking and Refreshment Break

10:45

New ORA Program Alignment — How the Restructuring Impacts You!

Ashley Reiber
Recall Coordinator
FDA

Cecilia Wolyniak
Lead, Consumer Safety Officer
OEIO, DE, FDA

11:30

FDA TOWN HALL EXCHANGE

This interactive session allows attendees to communicate directly with those that regulate the recall process. All conference attendees have the opportunity to submit questions in advance for the FDA to discuss during this Town Hall Exchange.

Ron Brown
Team Leader
CDER/Office of Compliance, FDA

Ashley Reiber
Recall Coordinator
FDA

Israel Santiago
Branch Chief, Recalls and Shortages Branch,
Office of Drug Security, Integrity and Recalls
CDER/Office of Compliance, FDA

Maureen Bernier
Biomedical Engineer, Recall Coordinator,
CDRH, FDA Office of Compliance
DAPO, Recall Branch

12:15

Networking Luncheon and Roundtable Discussions

This closing roundtable discussion provides attendees an opportunity to interact with their peers. Participants break into small groups to discuss effective strategies to tackle challenges when encountering a recall.

Jeffrey Moster
Director, Post Market Surveillance
Hill-Rom

1:30

Close of Conference

Want more agenda details? Download the brochure.

Day One | Monday, September 25, 2017

12:15

Conference Registration

1:15

Chairperson’s Welcome and Opening Remarks

Pearley Bhambri
Senior Director, Global Quality Systems
Hill-Rom

1:30

FDA Regulatory Requirements, Expectations and Trends

Israel Santiago
Branch Chief, Recalls and Shortages Branch,
Office of Drug Security, Integrity and Recalls
CDER/Office of Compliance, FDA

2:15

CASE STUDIES Mobilize and Deploy a Field-Based Team During a Recall

Hillary Medina
Senior Director, Recall Solutions
Novasyte

3:00

Networking and Refreshment Break

3:30

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

1 Senior-Level Think Tank — Assessment Leading into a Recall

In this closed-door session, senior-level recall professionals engage in open discussions with colleagues on assessments leading into a recall. 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 seniorlevel professionals who pre-register for the interactive discussion group. To pre-register, you must have over five years of experience and currently work for a pharmaceutical, biotechnology or medical device company.

CBI reserves the right to qualify participants for this workshop.

Pearley Bhambri
Senior Director, Global Quality Systems
Hill-Rom

 
2 Recall Fundamentals and How to Improve Recall Strategies from Start to Finish

It is essential that teams understand effective methods and strategies to successfully manage a recall. Benefit from this in-depth session by learning how to improve recall strategies from start to finish.

Sonali Gunawardhana
Attorney at Law
Wiley Rein LLP

5:00

Close of Day One

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

Day Two | Tuesday, September 26, 2018

8:00

Case Study Breakfast Roundtable

Speakers and the CBI recalls community bring blind case studies to the table and talk them through as a group, identifying challenges faced and walking away with best practices.

8:45

Chairperson’s Review of Day One

Pearley Bhambri
Senior Director, Global Quality Systems
Hill-Rom

9:00

INTERACTIVE SESSION —
Execute a Mock Recall to Ensure Team Readiness

From the passage of the 21st Century Cures Act to increasing challenges with counterfeit drugs, the environment surrounding pharmaceutical regulations is constantly shifting. It is important for pharmaceutical companies to continually reevaluate their recall plans and regularly hold mock recalls to ensure rapid team response. During this interactive session, attendees break into collaborative working groups to execute a mock recall. Teams are provided with key information needed to analyze the severity of the issue and develop a strategy for every stage of the recall lifecycle, including consignee notifications, response management, product processing and close out with the FDA. The groups then come together to share lessons learned and identify techniques for increasing efficiency and effectiveness.

Exercise Outline:

I. Understand the Scope of the Issue

II. Develop a Recall Strategy

III. Collaborate with the FDA and Identify Regulatory Documentation Requirement

IV. Identify Consignees and Construct a Notification Plan

V. Execute a Mock Recall Exercise

VI. Terminate the Mock Recall and Assess Key Takeaways

Lessons Learned and Key Takeaways:

Attendees develop a better understanding of the full recall lifecycle and are able to identify potential gaps in their current plans.

Amanda Combs
Recall Consultant
Stericycle

Willie Bryant
Expert Consultant
Stericycle

Chris Harvey
Director, Recall Solutions
Stericycle

10:30

Networking and Refreshment Break

11:00

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

3 Drug Recalls — An Update with FDA

Join FDA and industry experts for a discussion on effective drug recalls. Learn from the opportunity to hear their diverse experiences with the recall process and lessons learned.

Israel Santiago
Branch Chief, Recalls and Shortages Branch,
Office of Drug Security, Integrity and Recalls
CDER/Office of Compliance, FDA

Ron Brown
Team Leader
CDER/Office of Compliance, FDA

 
4 Device Recalls — An Update with Industry and FDA

Benefit from a discussion between industry experts and the FDA on specific considerations for medical device recalls. This is an opportunity to hear from the FDA and industry stakeholders regarding best practices, regulatory standards and their roles in the recall process.

Maureen Bernier
Biomedical Engineer, Recall Coordinator,
CDRH, FDA Office of Compliance
DAPO, Recall Branch

Hal Baden
Recall Coordinator & Distribution Logistics QA
Cordis, A Cardinal Health Company

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

12:30

Networking Luncheon

1:30

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

5 Ensure Timely and Effective Recall Communication to Minimize the Impacts on Brand and Reputation

Communicating a recall to those involved internally and externally (consumers) greatly impacts the overall effectiveness of the recall. Communicating poorly results in dissatisfied customers and potential legal issues, which negatively affects your brand. This session focuses on best practices for proper targeted communication to relay timely, appropriate information that influences the overall outcome.

Maureen Bernier
Biomedical Engineer, Recall Coordinator,
CDRH, FDA Office of Compliance
DAPO, Recall Branch

 
6 Make Proper Decisions About Initiating a Recall

This session focuses on the recall decision-making process and thought process of those involved when determining to conduct a recall.

Nina Mezu-Nwaba, PharmD, MPH, MSc, CAPT
United States Public Health Service, Senior Scientific Reviewer
CDRH/OC/DMQ/FDA

Ron Brown
Team Leader
CDER/Office of Compliance, FDA

3:00

Networking and Refreshment Break

3:30

Implement Successful Execution Strategies for Voluntary Recalls

Lavinia Marinescu-Pedersen
Senior Product Defects and Recalls Advisor, Customer Complaint Center
Novo Nordisk

4:15

Close of Day Two

Day Three | Wednesday, September 27, 2017

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day Two

Pearley Bhambri
Senior Director, Global Quality Systems
Hill-Rom

8:45

Best Practices to Prepare for Audits and Inspections

Maureen Bernier
Biomedical Engineer, Recall Coordinator,
CDRH, FDA Office of Compliance
DAPO, Recall Branch

9:30

How to Build a Globally Integrated Recall Process

Pearley Bhambri
Senior Director, Global Quality Systems
Hill-Rom

Jeffrey Moster
Director, Post Market Surveillance
Hill-Rom

10:15

Networking and Refreshment Break

10:45

New ORA Program Alignment — How the Restructuring Impacts You!

Ashley Reiber
Recall Coordinator
FDA

Cecilia Wolyniak
Lead, Consumer Safety Officer
OEIO, DE, FDA

11:30

FDA TOWN HALL EXCHANGE

This interactive session allows attendees to communicate directly with those that regulate the recall process. All conference attendees have the opportunity to submit questions in advance for the FDA to discuss during this Town Hall Exchange.

Ron Brown
Team Leader
CDER/Office of Compliance, FDA

Ashley Reiber
Recall Coordinator
FDA

Israel Santiago
Branch Chief, Recalls and Shortages Branch,
Office of Drug Security, Integrity and Recalls
CDER/Office of Compliance, FDA

Maureen Bernier
Biomedical Engineer, Recall Coordinator,
CDRH, FDA Office of Compliance
DAPO, Recall Branch

12:15

Networking Luncheon and Roundtable Discussions

This closing roundtable discussion provides attendees an opportunity to interact with their peers. Participants break into small groups to discuss effective strategies to tackle challenges when encountering a recall.

Jeffrey Moster
Director, Post Market Surveillance
Hill-Rom

1:30

Close of Conference