Agenda – 2nd Product Complaints Forum

  • Day One
  • Day Two

Day One

 Monday, March 26

8:45AM – 9:00AM

Chairperson’s Opening Remarks
Vaishali Shukla, Director, Due Diligence and Quality Integration, SHIRE
Michael Van Ryn, Sr. Staff Regulatory Compliance Specialist, STRYKER

9:00AM – 9:45AM

Audit Preparation: New Incoming Challenges With Product Complaints
Lawrence Perruzza, Director/Head, Case Investigation and Resolution, ROCHE

9:45AM – 10:30AM

Impact of Monitoring Trending and Metrics Impact on Product Complaints
Gregory Ellis, Senior Manager Product Monitoring, Quality Assurance, ALEXION PHARMACEUTICALS

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Identify All Risks Throughout the Product’s Life Cycle
Sonny T. Nguyen, Director of Quality Assurance and Regulatory Affairs, PERIGEN

11:45AM – 12:30PM

Drug Safety and Risk Management Complaints
Jaylaxmi Nalawade, Senior Manager — Drug Safety and Risk Management, LUPIN LIMITED

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Explore How to Monitor Worldwide Inspections to Help Protect Your Brand
Sophie Vaillot, Regulatory Affairs Director and Leader of Global Postmarket, GE HEALTHCARE

2:15PM – 3:00PM

Navigate the Fundamentals of Recalls
Joe Falvo, Senior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS

3:00PM – 3:30PM

Networking Break

3:30PM – 4:15PM

Utilizing Social Media to Actively Engage With Customers and Encourage Product Feedback
Sharon Perez, Ph.D., Director, Global Medical Safety, NOVOCURE

4:15PM – 5:00PM

CAPA System Within the Pharmaceutical Quality System
Krishna Kotha, Associate Director — External Manufacturing, DR. REDDY’S LABORATORIES

5:00PM – 5:45PM

Prepare for an Inspection to Avoid Inspection Findings — Pharma/Medical Device Perspectives
Michael Van Ryn, Sr. Staff Regulatory Compliance Specialist, STRYKER
Vaishali Shukla, Director, Due Diligence and Quality Integration, SHIRE


Day Two

 Tuesday, March 27

 

Medical Device

9:15AM – 9:30AM

Chairperson’s Recap of Day One

Michael Van Ryn, Sr. Staff Regulatory Compliance Specialist, STRYKER

9:30AM – 10:30AM

Medical Device Reporting and Recall

Michael Van Ryn, Sr. Staff Regulatory Compliance Specialist, STRYKER

10:30AM – 11:00AM

Implement How to Handle Medical Device Complaints

Sonny T. Nguyen, Director of Quality Assurance and Regulatory Affairs, PERIGEN

Pharma/Biotech

9:15AM – 9:30AM

Chairperson’s Recap of Day One

Vaishali Shukla, Director, Due Diligence and Quality Integration, SHIRE

9:30AM – 10:30AM

Risk Management Metrics and Product Complaint Expectations

Krishna Kotha, Associate Director — External Manufacturing, DR. REDDY’S LABORATORIES

10:30AM – 11:00AM

Regulatory Requirements for Safety-Related Product Quality Complaints Surpass Product Quality Issues and Drug Safety

Linda Lum, Team Lead Pharmacovigilance Science, Global Pharmacovigilance and Epidemiology, BRISTOL-MYERS SQUIBB

 

11:00AM – 11:30AM

Networking Break

 

Medical Device

11:30AM – 12:15PM

Use Statistically-Based Quality Metrics in Complaint Trending to Ensure FDA Compliance

Julii Lindquist, VP Quality and Regulatory, WESTERN ENTERPRISES

Pharma/ Biotech

11:30AM – 12:15PM

Quality Risk Management in Handling Pharmaceutical Product Complaints

Vaishali Shukla, Director, Due Diligence and Quality Integration, SHIRE

12:15PM – 1:00PM

Benchmarking What Should (and Shouldn’t) go into a Consumer Complaint Investigation

Richard Shields, Consumer Complaint Investigator, Consumer Health, BAYER

 

1:00PM – 2:00PM

Luncheon

 

Medical Device

2:00PM – 2:45PM

Combination Products and the Impact of FDA Rulings

Khaudeja Bano, M.D., Senior Medical Director, ABBOTT

2:45PM – 3:15PM

Risk-Based Customer Complaint Handling for Medical Devices

Sophie Vaillot, Regulatory Affairs Director and Leader of Global Postmarket, GE HEALTHCARE

Pharma/ Biotech

2:00PM – 2:45PM

Creative Strategies on How to Manage Drug Recalls

Sameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS UNIVERSITY

2:45PM – 3:15PM

Consumer and Customer Complaint Trending

Rupesh Patel, Product Quality Complaint Lead, Associate Director, OTSUKA