Recent projects include mentoring and coaching roles in design control documentation; design of a combination product quality risk management system; performing investigations and CAPA; technical document writing and requirements, and ISO13485:2016 auditing and audit prep. I assist pharmaceutical and medical device manufacturers; analytical testing laboratories; and API manufacturers of all sizes with quality system requirements and implementation - current with industry best practices and US and OUS regulatory requirements and expectations. I also provide hands-on assistance on-site as an Interim Quality Manager, Director, etc. See description below under AccuReg for further details of my consulting experience.

Professional consultant in cGMP and ISO compliance and regulatory activities for FDA regulated companies. In this role I have performed many different types of quality system projects at medical device and pharmaceutical companies, such as: development and implementation of quality systems; consolidation of quality systems within corporate organizations; compliance gap analyses; design control and risk management projects; internal and 3rd party auditing; Quality Feedback systems design, implementation, assessment, and reporting; analysis of data and information using statistical process control and analyses; Annual Product Quality reporting; Management Review reporting; laboratory controls and test method validation; process validation; test method R&R: validation of qualitative and quantitative medical device inspection methods; CMC and DMF submissions; FDA 483, warning letter, and consent decree remediation, and more.

FluoroMed is a novel API and medical device manufacturing company specializing in fluorinated hydrocarbons for medical applications. I worked to design and commission the plant and implement a Quality System for both drug and medical device manufacturing, including aseptic processing. I was responsible for all aspects of drug and device cGMP and EU compliance and regulatory affairs for marketed and development drugs and APIs, and for providing quality services to our customers.