2018 Product Recalls Forum (exl)

2018 Product Recalls Forum 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 Agenda Day One MONDAY | MAY 218:00AM – 9:00AMRegistration and Continental Breakfast9:00AM – 9:15AMCo-Chairpersons’ Opening Remarks9:15AM – 10:00AMBest Practices to Help Understand the Fundamentals of Recalls in Your OrganizationJoe Falvo, Senior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS10:00AM – 10:45AMMethods and Strategies for a Recall Execution: Why Create a Recall StrategyJoe Falvo, Senior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS10:45AM – 11:15AMNetworking Break11:15AM – 12:00PMFDA KeynoteMaureen M. Bernier, MME, PE, Biomedical Engineer, Recall Coordinator, FDA12:00PM – 1:00PMLuncheon1:00PM – 1:45PMRecall Management Planning for the Unexpected — Prepare for a Mock Recall to Help Strengthen Your Action PlanPearley Bhambri, Senior Director Global Quality Systems and Post Market Surveillance, HILL-ROM1:45PM – 2:30PMDevelop a Recall PlaybookAlex Patterson, Director Post Market Quality, RESMED2:30PM – 3:00PMNetworking Break3:00PM – 3:45PMCase Study: Learn How to Manage Drug Recalls Better in the FutureSameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS UNIVERSITY3:45PM – 4:30PMUnderstand the Operations of Recalls and Field ActionsKatherine May, APM Predict Product Manager (XLP — Accelerated Leadership Program), GE HEALTHCARE4:30PM – 5:15PMAnalytical Testing for Product Complaints and Suspect Products for Product RecallsRavi Kalyanaraman, Ph.D., Associate Director, BRISTOL-MYERS SQUIBB5:15PM – Conference Concludes Day Two TUESDAY | MAY 228:00AM – 8:45AMContinental Breakfast8:45AM – 9:00AMCo-Chairpersons’ Recap of Day One9:00AM – 9:45AMCompounding Recall Process and Industry TrendsMelissa Stefko, Senior Director of Quality Assurance, WELLS PHARMACY NETWORK9:45AM – 10:30AMBest Practices During an InspectionJennifer Judge, Post Market Compliance, Regulatory Affairs, WELCH ALLYN10:30AM – 11:15AMNetworking Break11:15AM – 12:00PMMDR Reporting and Procedures for Completing ReportsMichael Van Ryn, Director, Post Market Regulatory Compliance, STRYKER12:00PM – 1:15PMCase Study: A Strategic Approach to Managing Product Recalls and Common Mistakes That Are Occurring1:15PM – 2:15PMLuncheon2:15PM – 3:00PMEU Perspective to Product Quality Complaints, Defect Reporting and Market ActionNoel Gaule, Head of Product Quality Surveillance, QP, SHIRE3:00PM – Conference Concludes Faculty Maureen M. Bernier, MME, PEBiomedical Engineer, Recall Coordinator, FDA Pearley BhambriSenior Director Global Quality Systems and Post Market Surveillance, HILL-ROM Joe FalvoSenior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS Noel GauleHead of Product Quality Surveillance, QP, SHIRE Jennifer JudgePost Market Compliance, Regulatory Affairs, WELCH ALLYN Ravi Kalyanaraman, Ph.D.Associate Director, BRISTOL-MYERS SQUIBBRavi Kalyanaraman, Ph.D., is an Associate Director at Bristol-Myers Squibb Company in the Global Analytical Technology group with Global Manufacturing and Supply. He received his Ph.D. from the University of Idaho in 1995 and did his post-doctoral work at the University of Puerto Rico. He served as a faculty member in the department of chemistry at Bemidji State University in Minnesota from 1996 to 2001. He has been with Bristol-Myers Squibb since 2002. His past laboratory work with Bristol-Myers Squibb was primarily in developing and validating chromatographic methods for quality control laboratories. For the last six years, he has focused on developing new and novel techniques to detect pharmaceutical counterfeits and raw material identification using vibrational spectroscopic techniques, such as Raman, mid-, and near-infrared (NIR). Currently, he leads a team of analytical scientists who are involved in the forensic and other investigation of products received from product complaints, corporate security and also from various manufacturing sites, including third-party manufacturing sites. Katherine MayAPM Predict Product Manager (XLP - Accelerated Leadership Program), GE HEALTHCARE Alex PattersonDirector Post Market Quality, RESMED Melissa StefkoSenior Director of Quality Assurance, WELLS PHARMACY NETWORK Melissa Stefko is an experienced Pharmaceutical and Biotechnology professional with a background in Quality Assurance and Quality Control in aseptic sterile processing. Prior to joining Wells Pharmacy Network, Ms. Stefko served as Head of Quality with a start-up 503B Outsourcing Pharmacy and gained a strong CGMP understanding through previous positions within pharmaceutical manufacturers. Ms. Stefko is an active member of the American Society for Quality as a Certified Quality Auditor and is a member of Institute of Environmental Sciences and Technology, American Society for Microbiology, Parenteral Drug Association, and IACP. Ms. Stefko holds a Masters in Business Administration, a Masters of Science in Biotechnology, and Regulatory Affairs Certificate. Sameer ThaparAssistant Professor and Advisor, Drug Safety and Pharmacovigilance Rutgers, THE STATE UNIVERSITY OF NEW JERSEY Dr. Sameer Thapar holds a doctorate of pharmacy, is Oracle Health Science Consulting’s Director of Global Pharmacovigilance, and is on faculty as Assistant Professor for the Drug Safety and Pharmacovigilance track of the Master in Clinical Trial Sciences program at Rutgers University. Dr. Thapar has 18 years of experience in operations within the pharmaceutical, biotech and CRO industries, with cross-functional experience in medical affairs, clinical operations, quality assurance and subject matter expertise in pharmacovigilance operations and compliance. He has built global departments and defended in successful FDA, MHRA and EMA health authority inspections. He is an active advisor in several U.S.-based life science industry conferences and participates as an invited speaker and panelist at global industry conferences. Michael Van RynDirector, Post Market Regulatory Compliance, STRYKER Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for: - Multiple participant discounts - Price quotations or visa invitation letters - Payment by alternate channels (PayPal, check, Western Union, wire transfers etc) - Event sponsorship NO REFUNDS ALLOWED ON REGISTRATIONS Prices may go up any time. Service fees included in pricing. ----------------------------------------------------------------- This event is brought to you by: ExL Events, Inc. - NewYorkEventsList http://www.NyEventsList.com http://www.BostonEventsList.com http://www.SFBayEventsList.com -----------------------------------------------------------------MYL171110CEV VIO180131UPD