John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
About
John E. Lincoln has over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new/changed product 510(k)s, process/product/equipment including QMS and software validations, ISO 14971 product risk management files/reports, Design Control/Design History Files, and Technical Files. He has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). John has prior experience in military, government, electronics, and aerospace industries. He is a peer-reviewed author, teacher, and speaker, and a graduate of UCLA.
Credentials
- 40+ Years FDA Regulated Industries
- 30 Years Independent Consultant
- UCLA Graduate
- Design Control & Technical File Expert
Topics Taught on EduCraft
- EO Sterilization Validation and Revalidation Under ISO 11135: Practical Implementation and Lifecycle Considerations
- Beyond Digital Batch Records: Managing FDA and EU GMP Documentation While Preserving Data Integrity
- Using SPC and Process Data to Support Quality, Stability, and Manufacturing Decisions
- Root Cause Analysis for GMP Investigations: Identifying Systemic Failures and Building Effective CAPA
- Using SPC and Process Data to Support Quality, Stability, and Manufacturing DecisionsWednesday, October 21, 2026
- IQ, OQ, PQ in the Verification and Validation Process
- FDA's 21 CFR Part 11 Add-On Inspections
- FDA Inspections After QMSR: What Replaces QSIT 2.0 — The New Inspection Reality
- The FDA Medical Device File (DHF, DMR, DHR, Market Authorizations) and EU MDR Technical Documentation
- Root Cause Analysis for GMP Investigations: Identifying Systemic Failures and Building Effective CAPAWednesday, July 8, 2026
- Beyond Digital Batch Records: Managing FDA and EU GMP Documentation While Preserving Data IntegrityTuesday, July 21, 2026
- EO Sterilization Validation and Revalidation Under ISO 11135: Practical Implementation and Lifecycle ConsiderationsMonday, August 3, 2026