Precision Consultants is the world’s premier advisor in matters related to FDA product approval, regulatory affairs and compliance. Through our global presence, we deliver strategy advice, compliance support and quality assurance leadership to clients in over 50 countries. Our evolving team consists of former FDA officials with the experience to ready a company of any size to successfully meet the challenges of today’s device and biopharmaceutical industry.
Carmen Medina. M.P.H., Ph.D.(c) Ms. Medina is 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.
Ms. Medina routinely presents at international and national conferences in the areas of regulatory strategizing, drug development and approval, Good Laboratory Practices (cGLPs), Good Manufacturing Practices (cGMPs), Good Clinical Practices (GCPs) and Quality Systems Regulations (QSR) and Quality System’s Inspection Techniques (QSIT) for Medical Devices. She is the author of various publications related to validation, regulatory and compliance topics, including a new and comprehensive textbook, The Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics published by Marcel Dekker, Inc.
Her presentations provide insights into emerging and current regulatory, compliance and drug approval trends within the FDA. She has assisted with the development and successful approval and commercialization of hundreds of products and continues to do so as the Principal of Precision Consultants, Inc. She also supports the venture capital and institutional funding communities through her evaluation of business plans related to biotechnology, pharmaceutical and device development.
Dr. Brian W. Hagen Dr. Brian W. Hagen is an internationally acknowledged authority and advisor in the field of decision and risk analysis as well as an author, educator, frequent speaker, and seminar leader. He is recognized for his contributions in methods of valuation in the face of decisions, risks, and uncertainties. He has been a practicing decision and risk consultant for over 20 years providing consulting, coaching, and training to more than 30 corporations in the Fortune 200 with primary focus on the life sciences industries. He is the co-author of “Solving the Corporate Value Enigma: A System to Unlock Shareholder Value”. Dr. Hagen holds a Ph.D. in decision and risk analysis from Stanford University.
John Wiskerchen John Wiskerchen is a distinguished chemist formerly with the U.S. Food and Drug Administration for over 30 year, serving the Seattle, San Francisco and Buffalo district offices. Mr. Wiskerchen served as the Seattle laboratory director and managed over 65 chemists, biologists, microbiologists, entomologists and other lab personnel. He received the Commissioners Distinguished Career Service Award in 1999 and received the FDA Group Recognition Award several times in his career. In addition, he earned the Award of Merit for the design and construction of the Seattle lab/office building in1989.
Dr. William White Dr. White is a specialist in Quality Assurance, Quality Control, Manufacturing, and Product Development services for the pharmaceutical and biologics industries. He specializes in qualification audits; gap analyses; corrective action plans; GLP/CGMP compliance assessment and upgrade; pre-approval preparation; process and analytical method development and validation; manufacturing development and validation; site transfer of CGMP manufacturing and testing processes for drugs, biologics, devices, and combination products; quality systems development; computer systems validation; GLP/CGMP training; GLP/CGMP laboratory certification; IND/NDA/PLA preparation (C/M/C section); 510k submissions (devices and combination products). Dr. White holds a Ph.D. from Lehigh University, Bethlehem, PA.
Dr. Janice Callahan Dr. Janice Callahan has been a statistical consultant for over 30 years. Her experience covers clinical trials, quality control, environmental impact studies, econometric modeling and artificial intelligence. She is expert in ANOVAs, linear and non-linear regression, categorical data analyses such as log-linear models and logistic regression, discriminant analysis and CART, and time series analysis such as Box-Jenkins models. (CAI licenses SAS and owns BMDP)
With physician principal investigators she identifies end-points, designs data collection forms, establishes experimental designs, calculates sample sizes, writes Statistical Analysis Plans, analyzes data, generates tables and writes the results into reports submitted to the Food & Drug Administration (FDA) for product approval. Statistical techniques used include ANOVAs, repeated measures ANOVAs, logistic regression, Fisher's Exact tests, Cochran-Mantel-Haenszel tests, and regression. She has participated in the design, analysis and submittal of numerous successful 510Ks, IDEs, BLAs, PMAs, and NDAs.
Dr. Callahan works with design engineers and quality control staffs in determining design and analysis plans for Taguchi-type parameter designs for both control and noise factors. She analyses results of these studies to determine optimal manufacturing parameter settings. She works with assay development teams in developing statistical methods for qualifying and validating assays including parallel line and slope ratio methods. She recently analyzed the Adenovirus Reference Material (ARMWG) standard to establish the label value. She also developed a Maximum Likelihood estimation method to carry out the estimation calculations. She currently serves on the committee that is rewriting section 111 of the USP.
Dr. Callahan’s credentials include:
• Ph.D., Mathematical Statistics from Johns Hopkins University, Baltimore, MD
• B.S., Applied Mathematics and Engineering Physics from University of Wisconsin, Madison, WI
Stephen Cozzette
Stephen Cozzette is a Process Engineering Manager/Director providing R&D and Manufacturing solutions in the international medical diagnostic device sector. Mr. Cozzette has 22 years on the front lines of all i-STAT/Abbott Point of Care cartridge products. He has provided guidance and structure in moving from the science to the solutions, pre-manufacturing to full production and is particularly adept at integrating design controls in an entrepreneurial reality. Mr. Cozzette is broad in knowledge and speaks vertically across companies.
Mr. Cozzette’s expert knowledge of blood diagnostic products and the point of care market is an essential ingredient in the PCI inventory of expertise. Solutions provided for ion selective electrodes (ISE), immunoassays (IA), precision plastic injection molding, pressure sensitive adhesives (PSA), micro dispensing, and thin film wafer processes.
Co-inventor of 9 current patents in the fields of microdispensing, biolayers, microfabricated biosensors and immobilized ligand receptors. Mr. Cozzette combines real world knowledge to the regulatory environment of medical devices.
A chosen speaker for product knowledge internally and externally Mr. Cozzette has made the complex simple to understand to thousands. Some external presentations include Bio MEMs 2002 Columbus Ohio, Telfer School of Management and Department of Chemistry at Ottawa University and the Canadian Forces Medical Group.
Mr. Cozzette received his BSc. Chemistry for State University of New York at Albany.
Serving United Kingdom • Spain • Italy • Croatia • Turkey • Singapore • Malaysia • India
