Faculty – 2018 Product Recalls Forum

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

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Ravi 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 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

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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 Thapar
Assistant Professor and Advisor, Drug Safety and Pharmacovigilance Rutgers, THE STATE UNIVERSITY OF NEW JERSEY

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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 Ryn
Director, Post Market Regulatory Compliance, STRYKER