Life science companies receive thousands of product complaints each year, which can lead to recalls. With an effective complaint management mechanism, life science organizations have a better chance to ward off inspections when using the appropriate guidelines and regulations. This year's event will focus on current trends, combination products, and strategies to reduce product complaints and inspections.
Our
2nd Product Complaints Forum will provide insight into how to improve the management of product complaints and potential recalls. This program will feature case studies, panel sessions, and two tracks designed to deliver information for pharmaceutical, biotechnology, and medical device professionals involved in all stages of handling product complaints and potential recalls.
Top Five Reasons to Attend
- Understand how to properly prepare for an FDA inspection
- Discuss and differentiate best practices in both medical device and pharmaceutical complaints
- Navigate the intricacies of the product complaint and recall regulatory landscape
- Improve your complaint and recall management to ensure safety in your products
- Review Combination Products, the impact of FDA rulings and regulations
Speakers
- Kaudeja Bano, M.D., Senior Medical Director, ABBOTT UNIVERSITY
- Gregory Ellis, Senior Manager Product Monitoring, Quality Assurance, ALEXION PHARMACEUTICALS
- Joe Falvo, Senior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS
- Krishna Kotha, Associate Director- External Manufacturing, DR. REDDY’S LABORATORIES
- Julii Lindquist, VP Quality and Regulatory, WESTERN ENTERPRISES
- Linda Lum, Team Lead Pharmacovigilance Science, Global Pharmacovigilance and Epidemiology, BRISTOL-MYERS SQUIBB
- Tom Middleton, Solutions Consultant, SPARTA SYSTEMS
- Jaylaxmi Nalawade, Senior Manager – Drug Safety and Risk Management, LUPIN LIMITED
- Sonny T. Nguyen, Director of Quality Assurance and Regulatory Affairs, PERIGEN
- Rupesh Patel, Product Quality Complaint Lead, Associate Director, OTSUKA
- Sharon Perez, Ph.D., Director, Global Medical Safety, NOVOCURE
- Lawrence Perruzza, Director/Head, Case Investigation and Resolution, ROCHE
- Richard Shields, Consumer Complaint Investigator, Consumer Health, BAYER
- Vaishali Shukla, Director, Due Diligence and Quality Integration, SHIRE
- Sameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance Rutgers, THE STATE UNIVERSITY OF NEW JERSEY
- Sophie Vaillot, Regulatory Affairs Director and Leader of Global Postmarket, GE HEALTHCARE
Please fill in your name and email to receive the conference agenda of this event.
Conference Day One - Monday, March 26, 2018
Conference Day Two - Tuesday, March 27, 2018
The agenda is available as PDF under downloads at the right side of the page.
Venue
Sheraton Philadelphia University City Hotel
3549 Chestnut St, 19104
Philadelphia, PA, USA
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
- Product Recalls
- Quality Systems and Engineering
- Patient Safety
- Medical/Consumer/Regulatory/Clinical Affairs
- Call Centers/Customer Service
- Compliance
- CMO Management
- Business Support Coordination
- Product Surveillance
- Clinical Operations
- Quality Compliance and Audits
- Postmarketing Surveillance
- Complaint Handling
- Quality Compliance
- QA and Supply Integration
- Global Device Coordination
This conference is also of interest to:
- Drug Safety and Complaint Software Companies
- Consulting Firms
- Law Firms
- Inbound Call Centers
Venue
Sheraton Philadelphia University City Hotel3549 Chestnut Street
Philadelphia, PA 19104
Sheraton Philadelphia University City is a dynamic lifestyle hotel with a contemporary urban design and lifestyle amenities for business and leisure travelers. Our beautifully renovated hotel offers cutting-edge technology, warm hospitality and beautiful social spaces where you are free to relax, meet, work, dine and do your thing. Our hotel is immersed in the culture and history of Philadelphia, from museums that trace world civilizations to ethnic eateries and elite universities.
To make reservations over the phone, please call 1-888-627-7071 and request the negotiated rate for “ExL’s March Meetings.”. To make reservations online
Click HereYou must book your room by March 12, 2018, in order to receive the group rate. Please book your room early, as rooms available at this rate are limited.
