GMP and cGMP Training Systems - About Us
GMP Training Systems, Inc.
David Markovitz, Founder and President, GMP Training Systems, Inc.
and creator of the GMP Training System™
Experience you can trust! With over three decades experience in the Life Sciences industry, David knows what it takes to keep your operation in Compliance with FDA regulations. He has assembled a team of highly qualified experts to ensure that you receive the highest quality consulting and training in a wide range of compliance topics. Each of our consultants has hands-on experience working in industry.
David Markovitz, Founder and President of GMP Training Systems, Inc., has over three decades of leadership and management experience in the FDA regulated industries. Having held positions as Manufacturing Laboratory Manager, Packaging and Filling Manager, Pilot Plant Manager, Manufacturing Engineer, Technical Training Manager, and Corporate Director of Education and Training, he has hands-on experience in effectively managing complexity with limited resources. David’s corporate experience was acquired at Nutrilite Products, SmithKline Beckman, Organon Diagnostics, and Ortho Diagnostics.
David had the rare privilege of assisting Dr. W. Edwards Deming, the 20th century’s leading quality guru, in several of his famed Four-Day Seminars. David created and led the Deming Roundtable, an intensive year-long cooperative effort involving eight different organizations working to implement Deming’s teachings. An internationally recognized and award winning speaker and workshop leader, David has been invited to present at conferences and meetings throughout the world. He is the recipient of the Gold Microphone Award (National Speakers Association) and the 2004 winner of the prestigious Connie Award for Professionalism on the Speaking Platform.
Gamal Amer, Ph.D. is Principal at Premier Compliance Services, Inc. He holds a Ph.D. in Chemical Engineering and has over three decades of experience in the pharmaceutical and related industries. Dr. Amer's experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publications.
Lynda Curtin is known as The Opportunity Thinker. She is President of deBono for Business and is an expert practitioner of world renowned de Bono Thinking Systems methods — the most powerful, proven and practical creativity and innovation tools available anywhere. Her extensive business background in a broad range of industries — product manager responsible for managing a variety of product lines from $20.0 million to over $100.0 million in sales connects with clients — she understands the fast pace of work having thrived on the firing line everyday for 18 years to deliver hefty sales and profit goals in the midst of rapid and revolutionary change. Lynda is well equipped to help clients tackle their business challenges with fresh new thinking. She has conducted workshops around the world for clients, including Hewlett Packard and Astra Zeneca.
David R. Dills has provided consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Through his work, Mr. Dills has been affiliated within the life sciences industry for two decades with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers.
John Dolan Ph.D. is most widely known as the author of LCGC’s popular LC Troubleshooting column. As editor of this column for over 20 years, Dr. Dolan has contributed more than 250 installments of practical advice to practicing chromatographers. John has written over 100 technical papers, many of which support the development and practical application of gradient elution LC. His books (with Lloyd Snyder), Troubleshooting LC Systems and High-Performance Gradient Elution, are standard references in laboratories worldwide. Dr. Dolan managed a regional contract research laboratory for 11 years for LC Resources and later Bioanalytical Systems, Inc. The lab, which he helped found in 1988, specializes in the development, validation, and application of LC-MS/MS methods to determine pharmaceutical compounds in biological matrices. In addition, he is one of the founders of LC Resources, Inc., a company dedicated to training chromatographers around the world. As an instructor for LCR and the American Chemical Society, John has instructed more than 10,000 students in practical LC techniques.
Matthew Gay has extensive hands-on experience in the Dietary Supplement and Pharmaceutical industries in both the Manufacturing and Quality Assurance areas. Proven expertise in solid dosage manufacturing, blister packaging, CAPA, NCR systems, product release, experimental studies, process controls, and process optimization.
Jim Gerner Ed.D., M.S., M.T.(ASCP) has over two decades experience as a consultant in the Pharmaceutical, Medical Device, and Food Industries and in a corporate manufacturing environment. Dr. Gerner is a registered Medical Technologist - M.T. (ASCP), and his education includes a B.A. in Medical Technology, M.S. in Curriculum and Instruction, an M.S. degree in Clinical Microbiology, and a doctorate degree, Ed.D., in Corporate Training and Development.
David Inglis Ph.D. is director of Ulverston GMP Consulting Ltd, specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry. He has extensive experience in assessment and improvement of QA/GMP systems, auditing, GMP training, inspection preparation and plant cleaning/decontamination, especially in bulk intermediates and APIs. During more than three decades in Quality Assurance in the pharmaceutical industry, Dr Inglis has gained extensive experience of Quality Management, through roles in QA laboratories, GMP compliance and regulatory compliance. He is a Qualified Person under EU Regulations.
Tom Jupille is President of LC Resources, a Consulting Editor for LCGC, and associate director of the California Separation Science Society (CASSS). Tom is the founder and moderator of Chromatography Forum, an on-line discussion group focused on providing practical support to practicing chromatographers. He has been a practicing chromatographer for more than 30 years, during which he has written more than 30 papers on chromatography and related subjects. He worked primarily in gas chromatography in the late ‘60s, switching to thin-layer chromatography in the early ‘70s and then to HPLC and ion chromatography in the late ‘70s. Over the past 20 years, Tom Jupille has presented courses and seminars in the field of chromatography to more than 5000 students. In addition to teaching, he has been involved in the development and support of computer modeling techniques for chromatography method development.
Carmen Medina is President of Precision Consultants, Inc. and is a former FDA investigator and a leading thinker in the field of Pharmaceutical Compliance and Quality Assurance. She is an international consultant with extensive experience in the medical device, pharmaceutical, and biotech industries. Ms. Medina was a Commissioned Officer in the United States Public Health Service from 1986 to 1992 during which time she served as a Field Investigator for the U.S. Food & Drug Administration, specializing in pre-approval inspections. Her experience includes being Director of Regulatory Affairs and Product Development at Ivax Corp. Having worked on both sides of the industry, the regulator and the regulated, Ms. Medina has a unique understanding of what it takes to be compliant. In addition, she is a Professor of “Advanced Quality Assurance for Biotechnology” at the University of California, San Diego.
Shib Mookherjea Ph.D. has has a proven track record in problem solving and extensive accomplishments in the areas of pharmaceutical development, marketing, quality assurance, quality control, process upgrade, analytical support for stability studies, environmental studies, worker exposure (OSHA), and validation in the laboratory. He has held senior scientist and management positions with multinational organizations, including Colgate Palmolive, Johnson & Johnson, Troy Corporation, BASF, and several academic institutions.
Miguel Montalvo is the President of Expert Validation Consulting, Inc. Before forming EVC, he was a Vice-President for AAC Consulting Group where he directed the business unit for the Validation Compliance Group at AAC, providing specialized compliance-focused consulting and management of validation projects for customers around the world. Previously, Mr. Montalvo held positions of increasing responsibility in the areas of Validation, Technical Services and Quality Operations for Millipore Corporation, Raytheon Engineers and Constructors, Mova Pharmaceutical Corp., Bristol-Myers Squibb and Baxter Healthcare Corporation. Miguel has assisted pharmaceutical, biotechnology, OTC and medical device firms in the areas of validation and quality systems for over two decades.
Douglas Platt is the Senior Technical Advisor for EWT Consultant Group and brings close the three decades experience in satisfying compliance and qualification requirements for global regulating bodies. His current focus is on helping companies manufacturing dietary supplements attain and maintain compliance with the new cGMPs for Dietary Supplements. His corporate experience includes positions with Chiron Corp., Baxter BioScience, International BioMedical Group, and Alpha Therapeutics, Inc.
Steven Walfish is President of Statistical Outsourcing Services and brings close to two decades of industrial experience providing statistical solutions to complex business problems. He was Senior Manager Biostatistics, Nonclinical at Human Genome Sciences in Rockville MD. Steven has held positions with PricewaterhouseCoopers, Chiron Diagnostics and Johnson & Johnson. He holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.