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.
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22/05/2018 Last update