Daniel Kamm, P.E.,
C.Q.A.Daniel Kamm, P.E.,
C.Q.A.
Daniel Kamm, P.E., C.Q.A., is the Principal Engineer of Kamm & Associates. He is an electronics engineer and regulatory affairs executive with over thirty years experience in the medical device business, specializes in Good Manufacturing Practices auditing, consulting, and training. He has made numerous successful 510(k) submissions. He also designs medical devices and thus has a unique grasp of the problems and solutions to the GMP problems encountered by the device manufacturer. He has assisted the smallest to the largest device manufacturers on a world-wide basis to become GMP compliant and pass FDA inspection. He has directed R&D, regulatory affairs, and quality assurance efforts in companies such as Beckton-Dickinson, Picker International, and Fischer Imaging. He is a Registered Professional Engineer and a Certified Quality Auditor. International experience includes assignments in Canada, China, Finland, France, Germany, Italy, Japan, Korea, Netherlands, and Sweden. Member, Association for the Advancement of Medical Instrumentation, Regulatory Affairs Professional Society. Senior Member, Institute of Electrical and Electronics Engineers. Past participant in standards writing committees of AAMI: Electrical Safety; Diagnostic Electrocardiograph. Mr. Kamm has a B.S. in Electrical Engineering from Washington University. Complete CV for Daniel Kamm, P.E.
To help our clients to economize in the use of contract workers, a group of independent consultants has established a working affiliation. These highly motivated group members work either individually or collaborate in teams to serve your needs. We invite you to look at this list, which includes a summary of their services, contact any or all who might be able to assist you in your work. Alternatively, contact Kamm & Associates and we will be happy to facilitate the communication for you with any of our affiliated consultants. We will be pleased to assist you in assembling an appropriate, qualified consulting team equipped to handle your project expediently, accurately, and economically.
David E. Bright, a regulatory affairs and quality assurance executive with over thirty-five years experience in the health care industry, is skilled in worldwide regulatory affairs and quality assurance strategy development and program implementation, corporate-wide compliance, staff training, and operational consulting to general management. He is effective in building FDA relationships and ensuring compliance with GMPs in diverse businesses, domestically and internationally. He has held senior level corporate regulatory affairs and quality assurance positions with Baxter Healthcare Corporation, American Hospital Supply Corporation, Ciba-Geigy Corporation, and Richardson-Merrell, Inc. He has also held the position of Resident Investigator with FDA. In addition to the Food and Drug Law Institute, he is a member of the Association of Food and Drug Officials, Regulatory Affairs Professional Society, and the American Society for Quality Control. Mr. Bright has a B.S. in Biology and Chemistry from Wake Forest University.
Carl
W. Bruch, Ph.D.
Carl Bruch is a consultant specializing in GMP and GLP compliance, preparation and review of 510(k)'s, IDE's & PMA's and in all forms of sterilization for medical devices and related issues such as cycle validation, particulates, pyrogens, LAL, bioburdens, biological indicators, microbial challenges and accelerated aging of sterile packaged devices. He held several positions while employed by the FDA from 1966 - 1982 including most recently the positions of Deputy Director, Office of Scientific Evaluation and Director of Medical/Scientific in the Bureau of Medical Devices. Prior to working at the FDA, he was Staff Scientist of the Exobiology and Planetary Quarantine Programs, Office of Space Sciences at NASA. Subsequently, his experience includes positions as Vice President of Quality Assurance/Regulatory Affairs at Skyland Scientific Services and Director of Regulatory Affairs at St. Jude Medical, Inc. Dr. Bruch is Co-Chairperson of AAMI's Sterilization Standards Committee and a member of the U.S. Technical Advisory Group to TC 198 (Sterilization of Health Care Products) of ISO. He has B.S. in Soil Microbiology from Michigan State University and a M.S. and Ph.D in Microbiology from the University of Wisconsin.
Carol
J. Carlson
Carol J. Carlson is President of Technical Writing Services, Inc., a technical writing and communications firm she founded in 1987 specializing in technical publications, training, and special event planning for the medical device, pharmaceutical, financial, and related industries. She is skilled in the preparation of required FDA documentation including policies, procedures, specifications, research and clinical data reports, IDE's, PMA's, 510(k)'s, IND's, NDA's, ANDA's, product-use instructions/manuals, as well as other GMP compliance documentation. Previous positions include: Instructor at the Illinois Institute of Technology, Manager of Technical Publications and Training at Baxter Healthcare Corporation, Supervisor of the Editorial Research Department at Encyclopaedia Britannica and Research Assistant at the Argonne National Laboratory. Ms. Carlson has a B.A. in Chemistry and English Literature from the University of Minnesota, and an M.B.A. in Finance and International Business from the University of Chicago.
Donald. P. Cox, Ph.D., M.B.A. is a scientist and business executive with over twenty-four years of diversified experience in the chemical, pharmaceutical, and biotechnology industries. He is academically qualified with scientific and business degrees and has published widely. For five years, he headed the regulatory affairs and science information functions at Janssen Pharmaceutica being responsible for numerous NDA, IND, and 510(k) submissions and approvals. Since 1989, Dr. Cox has owned and managed a research biologicals distribution company servicing the biomedical reagents market with immunology products including antibody gold conjugates for research or diagnostics applications. Dr. Cox also consults to the pharmaceutical industry in areas of quality assurance, regulatory affairs, and new product development. He has worked individually and as part of team efforts. His recent projects include devoting over 85 on-site days to an FDA-organized integrity audit, creating a regulatory strategy for developing a topical prescription product, and researching technical documentation associated with silicone gel breast implant technology for a group of attorneys. Dr. Cox obtained master's and doctorate degrees in bacteriology at the University of Wisconsin, and his EMBA at Temple University.
Eric
Mueller
Eric Mueller is President of EM Associates, a consulting firm serving the pharmaceutical and medical device industries in the areas of ISO 9000 Quality Systems, with particular emphasis on Design Control and Document Control; Product, Process, and Software Validation; and Supplier Quality Management. He is a quality assurance and regulatory affairs executive with over twenty-five years broad experience in the health care industry in the U.S, Europe, and Asia. He creates innovative solutions to customer quality needs, with special emphasis given to ISO 9000 compliance and training for implementation of new requirements. He has held senior level QA/RA positions with Baxter International and Travenol Laboratories. He is a member of the American Society for Quality (ASQ) including the Biomedical, Reliability, and Statistics Divisions, and the Regulatory Affairs Professionals Society (RAPS). Mr. Mueller has a B.S. in Chemistry from Case Institute of Technology.
Jan L. Zorn
Jan Zorn is a regulatory affairs professional with diverse experience in the areas of drugs, medical devices, biologics and pharmacy practice. She specializes in designing and conducting drug and medical device clinical studies and in product submissions. She is also experienced in regulatory compliance and compliance documentation, product labeling/advertising review and in product recall activities. She is a certified medical technologist and has experience directing regulatory programs for Amersham Corporation, Baxter Healthcare Corporation’s Alternate Site Business Group and most recently as Director of Regulatory Affairs for Caremark, Inc. She is a member of the Regulatory Affairs Professional Society (RAPS). Ms. Zorn received her B.S. in Biology from St. Mary’s College of Notre Dame graduating Magna Cum Laude and her MT (ASCP) Certification and Plasma Establishment Director’s Certification from Evanston Hospital.
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