Philip Scharago is a pharmaceutical consultant with extensive knowledge of ISO 13485, 14971, QSR GMP 820, ICH, MDD/EU, ICH, CGMP, Quality Systems, Risk-Based Auditing, process validation, and equipment qualification for pharmaceutical manufacturing and testing. He has more than twenty-five years working in the Medical Device and Pharmaceutical Industries in the areas of Quality Assurance and Regulatory Affairs and extensive experience developing and improving quality systems to meet FDA requirements and remediation of FDA-483 observations and Warning Letters.
Kristen Steel is a regulatory professional with a strong background in healthcare marketing, compliance and strategic partnerships within healthcare, CPG, and foodservice environments. She works with project and database management, organizational management, FDA/USDA/DSHEA regulatory and labeling requirements, as well as an international framework as it relates to product labeling.
Beth Ann Crozier-Dodson, Ph.D., is an international consultant on food safety issues for industry, academia, and food and diagnostic kit industries. Dr. Crozier-Dodson has spoken in, designed and taught customized microbiology/food safety workshops across the globe. She is a member of numerous professional and honor societies and has received a USDA Commendation for Contribution to Public Health. Her areas of specialty include microbiology, laboratory setup, environmental testing, aeromicrobiology, validation testing, consulting, and plant and facility audits.