Ricki A. Chase, M.S.
Ricki A. Chase, M.S., is Vice President at Lachman Consultants with over twenty-five years of experience in US FDA and similarly regulated industry. While Director of Investigations at FDA, Ms. Chase was responsible for domestic and international markets, inspections, investigations, sample collections, and critical emergency response programs for all FDA regulated commodities. She developed compliance cases to support Agency administrative and legal actions. As an Investigator, Ms. Chase was active in all FDA regulated commodities, with an expertise in medical devices and pharmaceuticals. Ms. Chase taught the basic medical device training course for new Investigators on behalf of the Office of Regulatory Affairs, represented FDA at local and national organizational conferences and received more than twenty accommodations for her work with FDA, including the Commissioner’s Special Citation.
Ms. Chase provides project development and leadership for the most complex, projects and maintains the ability to scale projects to client needs and organizational capabilities. While at Lachman Consultants, Ms. Chase has presented numerous webinars regarding combination products, design control, inspection readiness, remote inspections and developed the medical device forum and medical device week platforms to share relevant and emerging information with industry partners.
Ms. Chase is an accomplished and much-sought-after speaker, especially on the topics of Medical Device Current Events, FDA Compliance Trends, and FDA Inspection Readiness and Response. She has made numerous presentations, including “New Initiatives of FDA, Office of Regulatory Affairs” at ASQ, annual presentations regarding field activities, compliance activities, and trends in medical devices and drug program areas at Association of Food and Drug Officials, and compliance law and field activities at John Marshall Law.
Online, Ms. Chase has contributed her knowledge, insights, and expertise to webinars for the FDA News on Field Alert requirements (FAERS), and is an ongoing contributor to MedTech Insight on current topics in medical device compliance matters. In addition, she is also the host of two installments of Lachman Consultants’ webinar series on FDA-related topics.
Board and Association Participation
Her professional memberships and affiliations include the International Society for Pharmaceutical Engineers (ISPE), Parenteral Drug Association (PDA), Regulatory Affairs Professionals Society (RAPS), and Agence Français de Développment (AFD).