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Event Details


Product Recalls Forum On May 21, 2018

Understand Regulatory Requirements and Expectations to Minimiza the Number and Cost of Product Recalls

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Who should attend?

Open To All


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 To this: 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. - 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, Joe Falvo Senior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS, Noel Gaule Head of Product Quality Surveillance, QP, SHIRE, Jennifer Judge Post Market Compliance, Regulatory Affairs, WELCH ALLYN, Ravi Kalyanaraman, Associate Director, BRISTOL-MYERS SQUIBB Ravi Kalyanaraman, Ph.D. Associate Director, BRISTOL-MYERS SQUIBB, Katherine May APM Predict Product Manager (XLP - Accelerated Leadership Program), GE HEALTHCARE, Alex Patterson Director Post Market Quality, RESMED, Melissa Stefko Senior Director of Quality Assurance, WELLS PHARMACY NETWORK, Sameer Thapar Assistant Professor and Advisor, Drug Safety and Pharmacovigilance Rutgers, THE STATE UNIVERSITY OF NEW JERSEY, Michael Van Ryn Director, Post Market Regulatory Compliance, STRYKER


Early Bird Pricing - Conference Only - Register by April 6, 2018: USD 1895 Standard Pricing - Conference Only: USD 2095 Onsite Pricing - Conference Only: USD 2295


Camille Venturina

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