3rd Product Complaints Forum

Examine All Aspects of the Product Complaints Process to Obtain, Manage, File, and Respond Properly According to Industry Standards and Guidelines

Philadelphia, PA, United States

With pharmaceutical and medical device companies receiving thousands and thousands of product complaints and potential recalls each year, it's essential that they follow FDA requirements. By having an effective complaint management system, life science organizations have a better chance to ward off inspections by using the appropriate guidelines and regulations. Monitoring complaint trends over time and having a complaint program improves the customer's experience with your products.

The 3rd Product Complaints Forum will expand on last year's conference by providing current trends, best practices, and strategies to reduce product complaints and avoid inspections. Come network and learn from over 65 industry experts and choose between two tracks on Day Two that explore specific industry challenges for the pharmaceutical and medical device industries.

Top Five Reasons to Attend

  1. Understand how to properly prepare for an FDA inspection
  2. Discuss and differentiate best practices in both medical device and pharmaceutical complaints
  3. Navigate the intricacies of the product complaint and recall the regulatory landscape
  4. Improve your complaint and recall management to ensure safety in your products
  5. Review Combination Products, the impact of FDA rulings and regulations

Who Should Attend

This event is designed for pharmaceutical, biotech and medical device professionals with responsibilities in the following areas:
  • Product Complaints
  • Product Quality
  • QA/QC
  • Product Safety
  • Quality System and Engineering
  • Patient Safety
  • Medical Affairs
  • Consumer Affairs
  • Call Centers/Customer Service
  • Compliance
  • Regulatory Affairs
  • Clinical Affairs
  • Sr. Research Investigator
  • CMO Management
  • Business Support Coordinator
  • Global QA Manager
  • Sr. Product Surveillance Specialist
  • Director Clinical Operations
  • Director, Quality Compliance, and Audit
  • Postmarketing Surveillance
  • Quality Specialist, Complaints Handling
  • Associate Director, Quality Compliance
  • Supervisor QA and Supply Integration
  • Quality System and Engineering
  • Quality Engineer
  • Global Device Coordinator
This conference is also of interest to:
  • Drug Safety and Complaint Software Companies
  • Law Firms
  • Inbound Call Centers


  • Craig Adelman, QA Post-Market Surveillance Manager, SHIRE PHARMACEUTICALS
  • Khaudeja Bano, M.D., Senior Medical Director, ABBOTT DIAGNOSTICS
  • Frank Chan, Process and Project Manager; Quality Systems and Quality Management, Global Complaint Management for Combination Products and Devices, GENENTECH
  • Joe Falvo, Senior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS
  • Ingrid Fausset, Associate Director, Quality Post Market Surveillance, SHIRE PHARMACEUTICALS
  • Michael Hunn, ASQ CQE, CQA, EFQM, QA Project Manager, Integrated Management System, DRAGER
  • Bob Miller, Ph.D., Senior VP Quality, GILEAD SCIENCES
  • Jayet Moon, Senior Quality Engineer, TERUMO MEDICAL CORPORATION
  • Rupesh Patel, Director, Product Quality- Product Complaints and Quality Systems, OTSUKA PHARMACEUTICAL
  • Sharon Perez, Director, Global Medical Safety, NOVOCURE
  • Gay Steinbrick, Lead Medical Device and Combination Products, Global Safety, MERCK & CO, INC.
  • Sameer Thapar, Professor, Drug Safety and PV, TEMPLE UNIVERSITY
  • Dhaval Trivedi, Manager, Post Market Surveillance, DRAGER
  • Trudy Yin, Director, QA Systems, PUMA BIOTECHNOLOGY


The Inn at Penn, A Hilton Hotel
3600 Sansom Street
Philadelphia, PA 19104

Discover a huge variety of Philadelphia attractions and activities within minutes of The Inn at Penn, a Hilton hotel. We're right on the campus of the University of Pennsylvania. From museums and tours to art and cultural and family attractions, there's a whole vibrant city to discover.

To make reservations please call 215-823-6240 and request the negotiated rate for ExL's March Meetings. To make reservations online Click Here

The group rate is available until March 4, 2019. Please book your room early as rooms available at this rate are limited.
Event details
Organizer : ExL Events
Venue : The Inn at Penn, A Hilton Hotel, Philadelphia, PA, United States
Event type : Conference
Reference : ASDE-19171