Anita Thibeault is president and founder of Anita Thibeault & Associates, a medical device international consulting firm located in Roswell, GA. She has 12 years of experience in the device industry. She has held positions as vice president of regulatory affairs, clinical affairs, and quality assurance. Ms. Thibeault was a corporate officer and president for a small start-up medical device company. She has also performed due diligence evaluations for companies interested in acquisitions. Ms. Thibeault has 22 years of experience in process validation, design controls, and quality systems development and their applications in a variety of products including disposables, implantables, instruments, and high-tech products. She has been an adjunct faculty member of California State University, Fullerton, where she taught workshops in process validation, design controls and quality systems, and product submissions. She has a certificate as a lead assessor for ISO 9000 standards and has worked with both industry and FDA as a GMP expert witness in quality systems and process validations. Ms. Thibeault is also a former member of the FDA's GMP Advisory Panel and a voting member during development of the quality system regulation. She is past chairman (1989 and 1991) of the Biomedical Division of the American Society for Quality (ASQ). She has been a member of MD&DI's Editorial Advisory Board since 1991. She has conducted quality system audits since 1977 and was honored as Auditor of the Year in 1997 by the GMP Institute. She has performed gap analysis audits as well as supplier audits, compliance audits, and consent decree certification audits. Ms. Thibeault is an international speaker and provides consulting for companies worldwide. She has a BS in chemistry and has attended law school.