FDA
Compliance Help Experienced • Effective •
Affordable
FDA
Compliance Help Experienced • Effective •
Affordable
Clients get better results through outsourcing - FDA submissions, documentation, procedure writing, validations, internal auditing, employee training, complaint handling (MDR), and CAPA projects.
About Us
Walt Brittle, M.B.A.
Managing Partner
Walt Brittle has more than 35 years experience and an in-depth knowledge of manufacturing, regulatory compliance, research and development, quality assurance and marketing. He has managed businesses offering sterility assurance products, endoscopes, surgical drapes, medical textiles, biological products, hospital supplies, specialized medical electronic devices, complex diagnostic systems, optics, laser systems, surgical instruments, microsurgery, and fiber optics. Brittle’s regulatory compliance work includes conducting quality system inspection technique (QSIT) audits addressing all ten elements in the FDA inspector’s guide and implemented follow-on system improvements. He has designed and implemented cGMP compliant quality systems; completed FDA warning letter recovery projects; and reviewed, submitted, and contributed to 510(k) applications for a number of firms. He has served in the clinical and surgical practice setting, followed by an extensive executive career with manufacturing, new product development, and contract engineering firms in North America, Europe, Japan, and Australia. Brittle has worked as a full-time business consultant since 1998 providing project based business improvement engineering services through Brittle & Company, SCORE Chapel Hill and FDA Compliance Help Desk, Inc.
EDUCATION AND TRAINING:
· University of Miami, MBA in Finance and Marketing
· University of Miami, BBA in General Management
· Undergraduate course work in biology and physiology
· Hospital Corpsman Training, Great Lakes U.S. Naval Hospital
· Clinical and Surgical Care Training (OJT), U.S. Naval Hospital and Dispensary
· Post-graduate study in information systems and inventory and process controls
· U.S. Coast Guard Reserve Officer Training
· Columbia University Executive Program
· Executive Technique, communication workshop
· New Product Development and Engineering course, New York University Extension
· American Hospital Supply Corporation, cGMP training, 1978
· Narco Scientific, regulatory compliance and cGMP training, 1982
· Surgicot, cGMP and Quality System (QS) Regulation training, 1997
· Steris Corporation, CAPA, design control, and MDR training, 1998
· Rx Textiles, Laragh course, 2004, including Fundamentals of Quality Management, ISO 9001:2000, Certification, and Auditing
Christine Brittle, Ph.D.
Christine@FDAcomplianceHelp.com
Dr. Brittle has over 9 years of work experience in qualitative and quantitative research including recruiting and site selection. She has served the U.S. Environmental Protection Agency, Washington, DC. as Environmental Protection Specialist in the Office of Ground Water and Drinking Water and has worked as a Research Analyst with The Media Network, Inc. designing and conducting research projects for government and private sector clients. Mrs. Brittle focuses on health, safety, risk and related issues.
EDUCATION
· Ph.D., Communication Studies University of Michigan, Ann Arbor, April 2005 GPA: 4.0/4.0
· A.B., Political Science Washington University, St. Louis, May 1997 GPA: 3.8/4.0, summa cum laude, Phi Beta Kappa
HONORS AND AWARDS
· Dissertation Enhancement Award, National Science Foundation (2004)
· Margaret Ayers Host Award for Women Graduate Students, University of Michigan (2004)
· Dissertation Research Award, University of Michigan (2003)
· Top Graduate Student Paper, Midwest Association for Public Opinion Research (2001)
· Regent’s Fellowship, University of Michigan (2000-2002)
· Bronze Medal, Environmental Protection Agency (2000)
· Customer Service Award, Environmental Protection Agency (1999)
· Arnold J. Lien Prize (Outstanding Graduate in Political Science), Washington University (1997)
· Academic All-American, GTE (1997)
· Woodward Fellow, Washington University (1993-1997)
AFFILIATIONS
· Society for Risk Analysis: Risk Communication Specialty Group
· American Association of Public Opinion Research
· National Communication Association
Tim Hubbard, B.S.E., J.D.
Dr. Hubbard is a biomedical engineer and attorney with more than 20 years of compliance consulting experience serving the medical device industry is a specialist in serving as U.S. Agent for foreign firms, new product pre-market approvals, product submissions, designing and managing preclinical data collection, and clinical trials. He has completed over 30 clinical data supported submissions. Dr. Hubbard has served as Adjunct Instructor, UNC Law School; Chief House Counsel for General Medical Corporation; Director, Regulatory Affairs, Associate Director, Clinical Affairs, for Zimmer USA (former division of Bristol Myers); and the Food and Drug Administration, Bureau of Medical Devices. Education: BSE, Biomedical Engineering, Duke University; Graduate work, Biomedical Engineering, Department of Surgery, Duke University and Department of Chemical Engineering, NC State University; and Juris Doctor, UNC Law School, Chapel Hill, NC.
ASSOCIATIONS AND RECOGNITION:
• Who’s Who in: (numerous editions), in American Law; in the South and Southwestern United States; of Emerging Leaders in America; in Industry and Finance; in the World; and in America (Marquis).
• American Bar Association, Vice Chair, Health Law Committee of General Practice Section, 1991 – 1993.
• North State Legal Services, President of Board, 1986 – 1989.
• Speaker of the House, NC Student Legislature, 1970; Duke delegate, 1968 – 1970; Chair, Duke delegation, 1970.
Teri C. "T.C." Soli, Ph.D.
Dr. Soli has 25 years of pharmaceutical industry experience covering chemical and microbiological analytical troubleshooting and development, quality control, quality assurance, project management, regulatory affairs, business development, process validation and troubleshooting, and all aspects of pharmaceutical water systems. His expertise with pharmaceutical water is extensive. He has been a private consultant and a trainer to the pharmaceutical industry in the areas of Pharmaceutical Water, Aseptic Processing & Sterilization, and Microbiological Troubleshooting for the last nine of those years and has served as an expert witness in several of his clients’ litigations. He is currently a member of the USP Pharmaceutical Water Expert Committee and has authored numerous papers, USP Chapters and Monograph revisions, and lectured extensively on various aspects of pharmaceutical water. He holds B.S. and M.S. degrees in Microbiology from Texas A&M University and a Ph.D. in Microbiology and Immunology with a Minor in Biochemistry from the University of Arizona.
PROFESSIONAL TASK FORCE MEMBERSHIPS AND ACCOMPLISHMENTS:
• Pharmaceutical Research and Manufacturers of America -- Water Quality Group Working member since 1982 and still active
• Concept originator (and author of proposed text) of the USP-23 changes for Purified Water and Water for Injection monographs relative to conductivity, TOC, and pH.
• Numerous publications in Pharmacopeial Forum providing conceptual background and rationale to Conductivity, TOC, pH and other water test changes.
• Numerous publications in Pharmaceutical Technology on water system design, operation, validation and troubleshooting.
• Frequent conference presenter on all above topics. USP Expert Advisory Panel on Microbiological Control and Process Validation Working member for 1995-2000 Revision Cycle
• Data development/evaluation affecting adoption of USP/NF standards for strength, quality, purity, bioavailability, packaging and labeling.
• Information evaluation/development related to adoption/modification of USP standards for microbiological quality of pharmaceutical and medical products
• Information evaluation/development related to adoption/modification of USP standards for validation of processes designed for microbiological control of products USP Pharmaceutical Water Committee of Experts Working member for 2000-2005 Revision Cycle
• Develop strategy and implement pharmaceutical water harmonization in USP, EP, and JP.
• Address attribute tests for packaged waters • Address other issues as assigned by USP
For a free consultation call
Washington, DC 1-202-241-3407
Chapel Hill, NC 1-919-942-1634
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FDA Compliance Help Desk, Inc. is a for profit NC corporation and is not affiliated with the U.S. Department of Health and Human Service
