Faculty – 2018 Product Recalls Forum

Maureen M. Bernier, MME, PE
Biomedical Engineer, Recall Coordinator, FDA

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Maureen Bernier, a Biomedical Engineer with FDA, has worked in CDRH Recalls for 17 years, as well as other departments in CDRH. She is a licensed Professional Engineer. Maureen has designed and developed medical devices at the National Institutes of Health (NIH) and in the diagnostic device and orthopedic industries, including two patents for hip implants. Her industry experience has given her insight into the design, manufacture, and use of many types of medical devices, as well as the procedures that manufacturers use for problem evaluation and corrective actions.

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

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Patrick Caines is Senior Director, Quality and Compliance, Baxter Healthcare where he is responsible for the company’s global quality systems and compliance and postmarket surveillance.

Patrick has over 20 years experience in quality systems and compliance for both medical devices and in-vitro diagnostics and served as Director, Corporate Postmarket surveillance, Boston Scientific, and GE Healthcare and Quality Director and Director of Worldwide Customer Quality at Johnson and Johnson.

Patrick served on the FDA Case for Quality where he led the post-production team and is currently leading his company’s postmarket surveillance and quality alignment with EU MDR, MDSAP, and ISO 13485 2016.

Patrick began his career as a hospital-based clinical chemist and held faculty appointments at the University of Windsor and Wayne State University. He holds a Ph.D. in Clinical Biochemistry from the University of Windsor, Ontario, Canada as well as an MBA from St. John Fisher College, Rochester, New York.

Joe Falvo
Senior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS

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With over 32 years of industry experience in Research & Development along with Quality, Regulatory and Compliance responsibilities, Joe has managed recalls and development of worldwide recall strategies for Ortho-Clinical Diagnostics for over 19 years. He liaises with numerous FDA District Offices (CDRH and CBER) regarding initial and follow-up recall reports, as well as supports the reporting of field actions to global Competent Authorities such as MHRA, ANSM, MHLW, etc. Joe expanded his responsibilities to Managing the Complaint Handling Unit in 2007, which included reportability determination, Regulatory Reporting (MDRs, Adverse Event Reporting, etc.), authoring of Health Hazard Evaluations, etc. As a recall/field action Subject Matter Expert, Joe has also provided expertise to other companies.

Daniel Jacob
Senior Medical Director, Medical Device Vigilance and GPS Quality System, BAXTER HEALTHCARE CORPORATION

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Board-certified internal medicine physician with 10 years of clinical practice experience both in the outpatient and inpatient settings. 13 years of industry experience primarily in Quality with focus on product complaints, recalls, adverse events (both drug and device), health hazard/medical product risk management and PV safety operations, compliance and technology. Presently, also the leader of the EU-MDR implementation project at Baxter Healthcare.

Ravi Kalyanaraman, Associate Director, BRISTOL-MYERS SQUIBB

Ravi Kalyanaraman, Ph.D.

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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

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Katherine “Katie” May is the Director of Workforce Deployment at GE Healthcare. Her focus is on the development of tools and processes to assist in strategic workforce decisions involving service engineers in the United States and Canada. She is currently leading the development of a simulation and modeling application that will help regional operations managers predict the impact of a retiring workforce on customer service level and key business metrics, as well as minimize customer and business impact.

Katie has 13 years of experience with the General Electric company, starting as an intern at the GE Aviation business in Cincinnati and moving to a full-time role as part of the Edison Engineering Development Program at GE Healthcare in Waukesha, WI in 2005. Previous to her current role, Katie was leading the implementation of a series of strategic initiatives to improve the service delivery model in Nigeria. She spent one year based in Lagos, Nigeria, embedded with the field service and service sales teams, focused on improving customer service, field engineering competency, service part logistics, and service sales. After her time in Nigeria, Katie spent six months building the commercial strategy for predictive service offerings in the US and Europe.

Prior to her role in Nigeria, Katie was the Global Services Manager for Recalls and Field Actions, with responsibility for service execution and process improvement of field actions across all service regions globally. She delivered a massive reduction in the number of open and late recalls and field actions across every product segment and every region. She established the operational rigor and built the operating model still in use today at GE Healthcare. Other previous roles include the Service Segment Leader for Nuclear Medicine and Advantage Workstation, Program Manager for the Maternal Infant Care segment, and the Lead Systems and Reliability engineer in the Radiography and Fluoroscopy segment.

Katie is also the business leader for the GE Healthcare’s Gay, Lesbian, Bisexual, Transgender, Ally (GLBTA) Alliance. Katie holds a B.S. in Mechanical Engineering from the University of Notre Dame and M.S. in Mechanical Engineering from Marquette University.

Michael Reid
Project Manager – Post Market Quality, RESMED

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Michael Reid is an experienced Product Development professional working across New Product Development, Global Product Management and Quality at ResMed. More recently, Michael has been focussing on Post Market Quality, managing recalls and field actions, and working to create more effective processes for global quality projects. As part of his current role Michael also manages the team responsible for global service delivery, and developing new processes in this key area of the business. Michael holds a Bachelor of Industrial Design (Hons), and a Masters in Project Management.

Vaishali Shukla
Head of Clinical QA and Product Quality Management, UNIQURE

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Vaishali Shukla is the Head of Clinical QA and Product Quality Management at uniQure. Vaishali is a Quality Compliance leader with over 14 years’ of experience in the biopharmaceutical industry, with expertise in a broad variety of subjects ranging from early clinical development (IND/NDA/ANDA/BLA) to commercialization of biologics & small molecules (solid oral dosage forms/liquid/inhaled). Vaishali started her career in Quality Assurance at BioVest Internationals, where she implemented novel processes for continuous development. She went on receive recognition for her contributions to the Quality systems at both Takeda and Shire Pharmaceuticals. In her current role at uniQure she is leading Quality Management and Clinical QA Teams responsible for Clinical Quality, Quality Systems, Partnerships, and Continuous Improvement. Vaishali holds a BS in Biology, a Masters in Botany, a Masters in Regulatory Affairs for Drugs, Biologics and Medical Devices, MS in Pharmaceutical Economics and Policy and is currently a Ph.D. candidate for Pharmaceutical Science.

Rob Smyth
Product Quality Service Lead, SHIRE

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Rob Smyth has a Masters Degree in Pharmaceutical Quality Assurance and Biotechnology. Rob works in Shire’s Product Quality Surveillance Section, as PQS Lead, responsible for complaints, escalations, Health Authority notifications and market actions, including recalls. PQS owns the recall procedure and is the core member of the Global Recall Team.
Prior to joining Shire, Rob worked for 10 years as a regulator with the Irish Medicines Board / Health Products Regulatory Authority, in the Quality Defects and Recall Programme. For recalls, this involved assisting with and coordinating recalls on the Irish market, providing industry guidance and presenting at IMB/HPRA information seminars. I also was an internal auditor and performed for-cause GMP and GDP inspections. Rob created the HPRA Guide to Reporting and Initial Investigation of Quality Defects in Medicinal Products.

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
Adjunct Professor, Drug Safety and Pharmacovigilance, Department of Pharmaceutical Sciences, TEMPLE UNIVERSITY SCHOOL OF PHARMACY

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Dr. Sameer Thapar holds a doctorate of pharmacy (Pharm.D.) and is Oracle Health Science Consulting’s Global Pharmacovigilance Director, based in the US and concurrently, holds an academic role of Professor, Drug Safety and Pharmacovigilance with a major US University. Dr. Thapar has over 20 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. Dr. Thapar is an active advisor in U.S.-based life science industry conferences and participates as an invited speaker and panelist at global industry conferences.