David A. Manalan, President and founder of INQC Consulting., has over 50 years of experience with companies regulated by FDA, EPA, OSHA and similar agencies. He has a degree in Chemical Engineering from the Massachusetts Institute of Technology and has done post graduate work in Biomedical Engineering at Northeastern University. David is a Fellow of the ASQ, a member of the Boston Section, an ASQ Certified Quality Auditor, Certified Biomedical Auditor, and Certified Software Quality Engineer. David has served on the board of the ASQ Biomedical Division’s New England Discussion Group for ten years, served as Publications Chair and as Program Chair for the ASQ Biomedical Division, and also as the Region 1 Councilor for the Food, Drug, and Cosmetics Division of ASQ. He is currently the Newsletter editor for the Biomedical Division’s newsletter, BIOFEEDBACK.
David has presented on the following topics over the past decade, Putting Closure on Complaints and Audits using CAPA, Non-conformance-Defining the Problem, Annual Product Review as Preventive Action, ASQ Biomedical Auditor Exam Overview, Validation-the big V, Device Establishment Registration & Listing, EN ISO 14971 and the MDD’s Essential Requirements, Combination Products, Complying with FDA GMP-Why It's Important for Life Sciences, Risk Management Guide for Small Businesses, MDSAP & FDA (Medical Device Single Audit Program & CDRH Case for Quality), MDSAP & Critical to Quality-an update, and Quality 2020- FDA.
Tuesday, May 21
4:00 PM – 5:00 PM