Each year, the number of drug and medical device increase on the market and so does the number of recalls. Product recalls in the pharmaceutical industry are not rare. In 2016 alone, manufacturers recalled 4,448 drug and device products, according to the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research. Life science organizations need to understand how to manage recalls and learn how to prevent recalls from occurring. By effectively implementing a recall notification in your organization, you have a better chance warding off product recalls.
Over the course of two days, this forum will not only go in depth with how to understand, anticipate, and prevent recalls, but also explore recent findings and the most common causes of recalls. Attendees will hear case studies, review FDA requirements and expectations, and leave the forum knowing how to tackle product recalls for both drugs and devices.
Top Five Reasons to Attend
- Strategize how to reduce recalls in your organization
- Review adapting to the new medical device regulations
- Explore recent findings and the most common causes of recalls
- Hear multiple examples of medical device and drug recalls and the tools to assist you in understanding the recall process
- Understand the fundamentals on how to effectively manage a recall in all stages from beginning to end
Who Should Attend
This event is designed for pharmaceutical,
biotech and medical device professionals with responsibilities in the
following areas:
- Product Recalls
- Patient Safety
- Product Safety
- Product Quality
- QA/QC
- Postmarketing Surveillance
- Quality Systems and Engineering
- Quality Compliance and Audits
- Complaint Handling
- Medical/Consumer/Regulatory/Clinical Affairs
- Product Complaints
- Compliance
- CMO Management
- Business Support Coordination
- Product Surveillance
- Clinical Operations
- 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
Speakers
- Maureen M. Bernier, MME, PE, Biomedical Engineer, Recall Coordinator, FDA
- Pearley Bhambri, Senior Director Global Quality Systems and Post Market Surveillance, HILL-ROM
- Patrick Caines, Ph.D., Senior Director, Quality and Compliance, BAXTER HEALTHCARE CORPORATION
- Joe Falvo, Senior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS
- Daniel Jacob, Senior Medical Director, Medical Device Vigilance and GPS Quality System, BAXTER HEALTHCARE CORPORATION
- Ravi Kalyanaraman, Ph.D., Associate Director, BRISTOL-MYERS SQUIBB
- Katherine May, APM Predict Product Manager (XLP - Accelerated Leadership Program), GE HEALTHCARE
- Michael Reid, Project Manager – Post Market Quality, RESMED
- Vaishali Shukla, Head of Clinical QA and Product Quality Management, UNIQURE
- Rob Smyth, Product Quality Service Lead, SHIRE
- Melissa Stefko, Senior Director of Quality Assurance, WELLS PHARMACY NETWORK
- Sameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS UNIVERSITY
Please fill in your name and email to receive the summit agenda of this event.
The agenda is available as PDF under downloads at the right side of the page.
Venue
Hilton Washington Dulles Airport
13869 Park Center Rd, 20171
Herndon, VA, USA
Venue
Hilton Washington Dulles Airport13869 Park Center Road Herndon
Herndon, VA 20171
To make reservations over the phone, please call 703-478-2900 and request the negotiated rate for ExL’s May Meetings. To make reservations online, please
click hereYou must book your room by April 20, 2018, in order to receive the group rate. Please book your room early, as rooms available at this rate are limited
