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The Alliance Training Cadre
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Kaiser J. Aziz, Ph.D.
Managing Director
KJ Biomedical Consulting LLC
Bowie, MD 20715
Work: (301) 805-0764
e-mail: kashj@juno.com
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Eoin Barry
ARV Excellence Ltd.
Enterprise Acceleration Centre
Moylish Park
Limerick, Ireland
+353 61 448 508 (Direct)
+353 87 280 6075 (Mobile)
e-mail: eoin@arvexcellence.com
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Biography: Kaiser J. Aziz
Kaiser J. Aziz, Ph.D., (Biochemistry – American University), Post-Doctorate (Health Sciences – University of Southern California), Graduate Certificate (Business Administration) – Georgetown University). Kaiser completed a 29-year career with FDA as a clinical regulatory scientist and manager of drug and device evaluations, approvals, reengineering, standards, good manufacturing and quality system applications. Kaiser worked with individual and industry organizations in design and total product life cycle (TPLC) approaches to premarket applications for medical devices, pharmaceuticals, and combination products PMAs and NDAs. Prior to joining FDA, he developed and implemented quality assurance standard operating procedures and protocols for medical diagnostic systems in hospitals, physicians’ offices, and clinical reference laboratories.
During his tenure at FDA, he served as an adjunct faculty in the Department of Medicine and Physiology, NIH Graduate School, where he developed and taught courses in Clinical Pharmacology, Toxicology, Therapeutic Drug Monitoring, and Clinical Laboratory Medicine. Currently he serves as an adjunct faculty at Virginia Tech’s Medical HACCP Alliance Program, where he teaches Risk Management Using HACCP Principles for the Pharmaceutical Industry. He has published numerous scientific and regulatory articles in professional and trade journals and serves as a member of editorial advisory boards of professional journals performing various functions such as writing editorials, evaluating manuscripts for suitability for publication, and technical review. He was an invited guest editor on Nanotechnology and Clinical Trials in the Journal of Clinical Ligand Assay in 2006.
Biography: Eoin Barry
Eoin Barry is programme director of ARV Excellence Ltd. a consultancy specialising in operational improvement, training and development. He is a graduate of the University of Limerick, Ireland we here he studied materials science (BSc) and business administration (MBA). Eoin certified as a six sigma black belt with AlliedSignal turbo charging division in 1996. He worked with organisations such as Stryker, Guidant and Boston scientific as a research scientist and senior quality engineer, validation subject matter expert and trainer in the DMAIC methodology. As programme director with ARV excellence Eoin designs and delivers training programmes that improve processes, operating profits and manage risk. These include lean six sigma green and black belt courses.
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Tony Chan, MBA, MSQA
Adjunct Professor, Virgina Tech
21520 Yorba Linda Blvd. Suite G288
Yorba Linda, CA 92887
U.S.A.
Phone & Fax: +1-714-779-8298
e-mail: ChanT@VT.edu
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Biography: Tony C. Chan
Mr. Tony C. Chan, MBA, MSQA, MS Reg. Sc., is Professor and Director of Risk Management Programs at Virginia Tech’s Center for Applied Health Sciences. He involves heavily in risk management standard activities for medical products both nationally and internationally. His work includes the research, development, training, and implementation of risk, quality and compliance management systems, system approach to total life cycle risk management, hazard analysis and critical control point programs, and a unified enterprise risk management. One of his latest efforts is working with healthcare facilities in preventing medical and medication errors. He has a total of close to thirty years of experience in the field of quality and reliability engineering from various industries, including pharmaceuticals, biological products, ophthalmic products, combination medical products, medical devices, in-vitro diagnostic devices, pathology laboratory equipment, computers, consumer electronics, and aircraft engineering. He was the Quality Development Advisor for the Vascular Intervention Division of Guidant Corporation responsible for the Quality Risk Management implementation. He led the implementation of a corporate risk management policy and a comprehensive risk management approach for the total product life cycle of vascular intervention products. His total life cycle HACCP Risk Management approach integrated with CAPA was recognized by the US FDA CDRH as the industry standard of practice. He has been training and consulting for both American and Asian Medical Product Industries including matured and start-up companies as well as institutions such as the US FDA Staff College, Association for the Advancement of Medical Instrumentation (AAMI), Advanced Medical Technology Association (AdvaMed), Beijing Hua Guang Certification of Medical Devices Co. Ltd. (CMD), Hong Kong Productivity Council (HKPC), Taiwan Industrial Technology Research Institute (ITRI), Taiwan Parenteral Drug Association (TPDA), and Enhealth Sdn Bhd., Malaysia. He won the 2008 AAMI Technical Committee Excellent Service Award.
International Activities:
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Senior Advisor, Asian Harmonization Working Party (AHWP) Work Group 3 on Quality Management System
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Expert Advisor, Global Harmonization Task Force (GHTF) Study Group 3 on Quality Risk Management System
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U.S. Co-Chair, U.S. Sub-TAG for ISO/IEC JWG1 – Medical Device Risk Management
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U.S. Technical Expert, ISO 31000 – Guidelines on Risk Management Principles
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Expert Member, IEC/TC56 PT 3.16 Technical Risk Management and PT 5.2 Risk Management, and IEC TC56 – Dependability
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Expert Member, AHWP, WG6 on Capacity Building and Regulatory Training
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Expert Member, IEC/SC62A, JWG – Usability
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Expert Member, Parenteral Drug Association (PDA) ICH Q9 Quality Risk Management Review Committee
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National and Local Activities:
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Trainer at the US FDA Staff College on HACCP Risk Management
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Senior ASQ Member, 7 Certifications (CQM, CQE, CRE, CQA, CHA, CBA, and CQI)
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Co-Founder & 2007-2009 Chairman, ASQ Temecula Valley Section (0713)
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Founder/Facilitator, Orange County Regulatory Affairs’ Risk Management Discussion Group
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Co-Founder, Orange County Chapter of Society of Reliability Engineers; four term President
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Member of U.S. TAG & Z1 for Dependability Management
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CSUs and USC Industry Advisor
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Biography: Jose Cotto
Mr. Jose Antonio Cotto brings over thirty (30) years of value added experience in FDA, USDA and EPA regulated Industry developing and implementing quality systems, auditing for regulatory compliance, Risk Management/Vulnerability assessment and support of the validation and technical service areas with extensive experience on analytical systems and environmental health and safety issues in chemical plants, pharmaceuticals, medical devices, food/beverage and healthcare providers. His experience covers the entire lifecycle of healthcare products from Design Review, sales & marketing to after Market surveillance for Companies such as Eli lilly, CibaVision, Warner Lambert, Schering, Abbott, BD and Millipore.
Mr. Cotto has successfully completed project management works with companies under regulatory enforcement action such as: Recalls, Product seizure, Warning Letters and Consent Decrees.
He has successfully developed and implemented Regulatory Compliance Projects in: Validation Management, Programs , Hazard Analysis & Critical Control Points (HACCP) Program for Medical devices & Food processors(qualified instructor), Environmental Monitoring Program Development For laboratories & Manufacturing Facilities, Laboratory design review & equipment qualification, Analyst Job Skills Training Certification Program, Bioterrorism Act of 2002 Titles 2 ,3 & 4 (food , Drug & water, Food Allergen & Consumer Protection Act of 2004.He has also managed Security and Vulnerability for Chemical and Microbiological laboratories and potable water plans following the Sandia National Laboratory’s (RAM-W) security risk assessment methodology for small and medium water utilities.
Mr. Cotto is the Founder and Principal Partner of CMC Xpert Group Inc a Blinded Veteran owned Enterprise dedicated to Strategic Technology Review, Specification, Procurement, supply, commission, Qualify& Training for Chemical & Microbiology laboratory equipment to Clients in Latin America and the Caribbean. He was a Histo-technology and Medical Technology Specialist in the USAF during the Vietnam War.
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William H. Duffell, Jr., Ph.D.
652 Wilds Cove Road
Franklin, NC 28734
Home: (828) 369-3355
Mobile: (303) 668-1691
e-mail: Bill@TheDuffells.com
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Biography: Antonio Duarte (Tony)
Tony has been in Quality Engineering for over 25 years and has experience with Nuclear, Aerospace, Military, Commercial Manufacturers and Medical Devices Industries.
Tony currently is a consultant and teaches courses in Hazard Analysis Critical Control Point (HACCP) and Risk Management/ Hazard Analysis. He has also taught classes in Quality Engineering, Quality Auditing & Mechanical Inspections. He has participated in several HACCP training courses. He holds ASQ Certifications for the CQE, CQA, CQA-HACCP, and CMI. Tony has a Bachelor’s Degree in Manufacturing Operations Management, and Associate of Arts degree’s in Quality Assurance & Industrial Technology. Tony is the West Coast Program Coordinator for Virginia Tech’s Center for Applied Sciences in Irvine Ca.
Tony is an active member of the American Society for Quality (ASQ) and has held positions as Section Chair, Vice-Chair and Treasurer for the San Diego and Temecula Valley Sections. Tony was Co-Founder of the ASQ Section in Temecula Valley (0713) and supported the establishment of the Medical HACCP Alliance.
Biography: William (Bill) H. Duffell, Jr.
William (Bill) H. Duffell, Jr., Ph.D. was recently appointed Sr. Vice President of Global Government Affairs for Gambro (based in Stockholm, Sweden) after having served as Gambro’s VP of Global Regulatory & Quality Assurance. Dr. Duffell has over 25 years of experience in regulatory, quality and clinical research with both small Venture Capitol companies and large multi-billion dollar corporations in the pharmaceutical, medical device and biotech industries. His experience includes business development for new innovative medical products, research and development, clinical research, quality assurance, regulatory affairs, reimbursement for new technologies, product launch, field sales support and product liability. Dr. Duffell has provided strategic and crisis leadership in the development and defense of a number of high profile medical products including breast implants, innovative biomaterials for the treatment of urological disorders and GMP violations resulting in import bans, warning letters and product recalls.
Dr. Duffell has twice served on FDA Advisory Panels – ENT and Hematology / Pathology Advisory Panels – and in January 2006 Dr. Duffell was confirmed by the White House and HHS Secretary Michael Leavitt as a member of one his committees in his Office of Public Health & Emergency Preparedness. In October, 1998, Dr. Duffell was called upon by Congressmen Tom Bliley and John Dingell to testify at a full Committee hearing on the Implementation of the Food and Drug Administration Modernization Act (FDAMA) and its impact on the development and market introduction of medical products and reimbursement for new technology healthcare products. In 1999, he was again called upon by both the U.S. Congress and the U.S. Senate, to provide an Industry update and a progress report on the implementation of FDAMA and to address global business issues affecting the healthcare industry.
Dr. Duffell received his B.S. in Biology from Rutgers University and his doctorate in Business Administration / Behavioral Sciences from Clayton University.
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George Flick, Jr., Ph.D.
University Distinguished Professor
Food Science and Technology Dept. (0418)
Virginia Polytechnic Institute & State University
Blacksburg, VA 24061
Work: (540) 231-6965
FAX: (540) 231-9293
e-mail: flickg@vt.edu
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John D. Menna
WSMS Mid-America LLC
105 Mitchell Road, Suite 200
Oak Ridge, TN 37830
Work: (303) 843-3097
FAX: (303) 843-2179
e-mail: john.menna@wxsms.com
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Biography: George J. Flick, Jr
George J. Flick, Jr. received his Ph.D. degree from Louisiana State University in 1969. He was employed at Virginia Tech as an Assistant Professor in 1969 and was promoted to University Distinguished Professor in 1996. He was a Visiting Professor in 1973 at the National University of Mexico (Chemistry Department) in Mexico City, Mexico under sponsorship through the Organization of American States. In 1985, he was a Visiting Professor (Department of Marine Biochemistry) at Tokyo University, Tokyo, Japan, through a Japan Society for the Promotion of Science fellowship. He is a co-author on risk management manuals for the seafood, medical device, and pharmaceutical industries. He assisted in developing two graduate programs (Graduate Professional Certificate and Master of Science Degree in Life Sciences) in Health Product Risk Management offered by Virginia Tech. He is the co-author of four books, forty-two book chapters, and over 175 journal articles on food product quality and safety. He is a Fellow of the American Association for the Advancement of Science and the Institute of Food Technologists. He has received numerous awards which include: Certificate of Appreciation, Department of the Army, United States Army Veterinary Command; Vice-President Al Gore National Performance Review Hammer Award; United States Department of Agriculture (USDA) Secretary´s Honor Award; United States Department of Agriculture (USDA) Secretary´s Group Honor Award; Institute of Food Technologists´ Elizabeth Fleming Stier Award; and Institute of Food Technologists´ Myron Solberg Award.
Biography: John Menna
Dr. Menna is Project Director for Washington Safety Management Solutions Mid America, a subsidiary of URS Washington Division, in Oak Ridge Tennessee. He has 24 years experience in regulatory affairs, risk management and safety engineering in the defense nuclear industry. His responsibilities have included the development and approval of licensing documentation for some of the Nation’s most hazardous nuclear and chemical facilities in the Defense Nuclear Complex.
Technical disciplines under Dr. Menna’s management purview have included hazard, accident, and risk analyses technology, model development and software V&V, human factors engineering and human reliability analysis, fire protection and emergency preparedness as well as quality assurance and the facility qualification testing. The governing DOE and industry standards included ASME/NQA-1 (Quality Assurance Requirements for Nuclear Facility Applications) and numerous federal regulations that address chemical process and nuclear safety and analysis.
Dr. Menna has mentored management and staff in the areas of integrated safety and risk management, implementation, operational readiness at a number of National Laboratories and nuclear facilities including: the Savannah River Site in Aiken, South Carolina, the Waste Isolation Pilot Plant (WIPP) facility in Carlsbad, New Mexico, the Oak Ridge National Laboratory in Tennessee, the Rocky Flats Environmental Technology Site in Golden, Colorado, the Plutonium Finishing Plant at Hanford, Washington, and the Idaho National Laboratory, and the Los Alamos National Laboratory, New Mexico.
Dr. Menna is a member of URS Washington Division’s Corporate Nuclear Safety Council. He holds a BS degree in Mechanical Engineering from the University of Rhode Island, MS and Ph. D. in Mechanical Engineering from Virginia Dr. Currently, he serves on the board of the HACCP (Hazard Analysis and Critical Control Point) Alliance, which is involved in applying hazard and risk management technologies from the food industry to the medical device and pharmaceutical industries.
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Captain Joseph L. Salyer, RS, MPH
Consumer Safety Officer
FDA/CDRH/OC/DOE A/GSDB
10903 New Hampshire Avenue
Building 66, Room 3554
Silver Spring, MD 20993
Phone: (301) 796-5468
Cell/Text: (703) 554-3777
Fax: (301) 847-8137
e-mail: joseph.salyer@fda.hhs.gov
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Biography: Valerie S. Rosemond
Ms. Valerie Rosemond has extensive experience in the Healthcare Industry, with emphasis in Biotechnology. She has worked as a Clinical Research Manager, a Project Quality Assurance Manager, a Medical and Pharmaceutical Consultant, a Director of Sterilization and Quality Improvement, and a Director of Quality Assurance and Regulatory Affairs for companies such as Mentor Urology, Inc., Cyberonics, Inc., Quality Management Systems, Baylor College of Medicine, and US Oncology, Inc.
Valerie received her B.S. in Biology from Gustavus Adolphus College, in St. Peter, Minnesota. She has certifications from the American Society for Clinical Pathology, Medical Technologist (MT 09168); from the American Society for Quality as a Certified Quality Manager/Organization Excellence (ASQ 6848); and from the American Society for Quality as a Certified Quality Auditor (ASQ 29370). Ms. Rosemond is a member the Regulatory Affairs Professional Society; the American Society for Quality, and the Society for Clinical Research Associates.
Her responsibilities have included:
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Project Management
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GMP/GCP/GLP training and skills development
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In-depth knowledge of Quality System Regulations
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Biomedical operating systems expertise
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Regulatory submissions and product approval (IND, NDA, IDE, BLA, 510K, PMA)
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Manufacturing methodology, tools and process development ( Pareto, DMAIC, Fishbone, Charts)
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Process improvement strategies (Six sigma, PDCA)
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Clinical trial research and adverse event reporting
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Internal and external auditing expertise
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Innovative process design & validation ISO 13485 & 14971
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OSHA regulations (hazards and blood-borne pathogens)
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Product marketing strategies & Design Dossier
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Oncology human research participant protection regulations 21 CFR PART 50, 56, 312,820, 314,210,211
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Business systems and financial planning
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Pharmaceutical drug, device, biologic, IVD consulting
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Overhead costs reduction, budget planning
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Product safety analysis pharmacoviligance, MDR, MDV
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MS Word, Excel, PowerPoint, Access, Project,
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Ms. Rosemond’s accomplishments have been many and varied. She has standardized the biomedical operating system including any contract specifications for an independent review of clinical trials. She discovered procedural, record omissions and corrected serious operator and compliance errors. These initiatives resulted in a successful FDA inspection and consistent workflow that improved the accuracy and reporting of document control data among 25 regulatory staff, while remaining within time and budget constraints.
Additionally, Ms. Rosemond managed and directed the consolidation of three independent business units addressing operational and compliance disparities. She lead the team effort in project implementation, and developed plans focused on correction and tracking of critical operations to include suppliers, test plans, and targeting key operating performance requirements. These efforts resulted in a 6-month accelerated European product CE Mark license, completion of EU design dossier and company-wide market launch.
Ms. Rosemond has also managed and directed the conversion of a manual vs. automated manufacturing system addressing operational disparities and product quality variability for Class II urology devices. She developed and reported on business improvement plans consistent with customer specifications that focused on supplier oversight and operating performance improvements. These initiatives resulted in 100% retention of customer base, consistent and uniform product quality, timely manufacturing product launch with minimum expenses and product liability issues, for an overhead cost savings of more than $250,000.
Biography: Joseph L. Salyer
CAPT Joseph L. Salyer, RS, MPH, is an Environmental Health Specialist in the U.S. Public Health Service. He is a Supervisor on the Preventative Medicine Team for the PHS-1 Rapid Deployment Force for disaster response.
CAPT Salyer has twelve years of experience with the U.S. Food and Drug Administration. He is currently a Compliance Officer in the General Surgery Device Branch, Division of Enforcement A, in the Center for Device and Radiological Health. He has served six years in this office and six years as a Field Investigator. While in the FDA, CAPT Salyer has worked with foods, drugs, devices, as well as imports. He also has industry experience in food, drugs, and device manufacturing.
CAPT Salyer completed a five year detail to the U.S. Coast Guard where he served as the Division Officer for Environmental Compliance on a major base. He was assigned to the Indian Health Service where he worked in general environmental health and injury prevention on an Indian reservation. CAPT Salyer also served in the U.S. Army at the Medical Research Institute for Chemical Defense. He has provided risk management training for the Department of Homeland Security, Transportation Security Administration, Freight Rail Industry Division.
Additionally, CAPT Salyer serves as Federal Liaison for the Global Risk Management Alliance (GRMA). GRMA is a non-profit tax exempt training organization. He is an expert in Hazard Analysis and Critical Control Points (HACCP) and editor of various HACCP related training manuals. CAPT Salyer is a Federal Liaison at Virginia Tech’s Center for Applied Health Sciences, Blacksburg, VA. He assisted in the preparation of the American Society for Quality Certified HACCP Auditor Exam. And he has conducted training and made presentations throughout the United States, Canada, Puerto Rico, Egypt, Ireland, and China. CAPT Salyer received his BS from Emory and Henry College, Emory, VA and his MPH from The Johns Hopkins University, Baltimore, MD. He currently resides in Leesburg, VA.
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Lorena Williams
Nuclear Safety Analyst and Risk Management Professional
WSMS Mid-America LLC
105 Mitchell Road, Suite 200
Oak Ridge, TN 37830
Work: (865) 425-7026
e-mail: lorena.williams@wsms.com
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Biography: Anshu Vashishtha
Dr. Anshu Vashishtha is a board certified internist with a PhD from The Rockefeller University, an adjunct professor at Virginia Tech Center for Applied Health Sciences, providing consultation services to the pharmaceutical industry for product safety and risk management. He has provided medical leadership at several multinational pharmaceutical companies for over a decade, and has been on the faculty of courses offered by organizations like the Drug Information Association, Food and Drug Law Institute & Drug Safety Research Unit in the areas of pharmacovigilance and risk management.
Biography: Lorena Williams
Lorena Williams is an accomplished Loss Control/Risk Management and Safety Analyst Professional with expertise in asset protection, loss prevention, product and process hazard analysis, exposure evaluation, and risk assessment and control in the insurance industry. In addition, Ms. Williams has 3 years experience in the development of technical basis and safety basis documentation for emergency management hazards screening and assessment in the nuclear industry. Ms. Williams has over 15 years combined experience and demonstrated leadership in risk evaluation, professional consulting, and customer relations within property and casualty insurance, nuclear, and healthcare industry environments.
Ms. Williams has lead risk assessment and exposure analysis tasks forces globally for life sciences customers ranging from biotechnology, medical device, pharmaceutical, and clinical trials companies. She served as a Global Life Sciences Risk Management Technical Lead and provided expert leadership and education for Loss Control Professionals at the Chubb Group of Insurance Companies. She has also developed guidance in the evaluation of property, liability, and environmental exposures and authored articles in disaster recovery, business contingency planning, and hazards analysis for medical products manufacturers.
Areas of expertise include:
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Healthcare risk analysis and control measure identification and implementation for patient safety risk management work.
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Hazards screening, analysis, and risk calculations for DOE nuclear facilities performing a various research projects and handling a variety of radiological and non-radiological materials.
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Development of technical basis documentation for emergency planning and response at DOE facilities handling chemicals and radiological materials.
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Risk assessment and business impact analysis for loss potential introduced throughout different stages of medical product development, including human clinical trials.
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Process hazard analysis and environmental impact analysis to determine liability exposures for a variety of companies in the manufacturing industry.
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