Expert Profile
John E Lincoln
Principal, J E Lincoln and Associates
John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years’ experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He 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 so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. He is a graduate of UCLA.
Trainings by Expert
10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance
Category:
Medical Devices
,
Risk Management
,
All FDA Regulated Industry
,
QMS, ISO 13485, CAPA
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Life Sciences
Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
Category:
Medical Devices
,
Risk Management
,
All FDA Regulated Industry
,
FDA Validation
,
QMS, ISO 13485, CAPA
,
Life Sciences
Change Control - Implementation and Management
Category:
Medical Devices
,
General Manufacturing
,
Life Sciences
Validation for FDA and ISO 13485 Compliance: Pack of Two Courses
Category:
Medical Devices
,
All FDA Regulated Industry
Medical Device QSR (21 CFR Part 820), Design Control, Hazard Analysis Under ISO 14971 and ICH Q9: Pack of 3 Courses
Category:
Medical Devices
Documenting a Risk-Based Quality System - for Compliance and Cost-Savings
Category:
Risk Management
,
All FDA Regulated Industry
,
Documentation and IT
,
Quality and Safety
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life Sciences
Risk-Based CAPA Systems
Category:
Medical Devices
,
General Manufacturing
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Life Sciences
Implementing a Risk-Based Internal CGMP Annual Audit Program
Category:
Medical Devices
,
Risk Management
,
All FDA Regulated Industry
,
FDA 21 CFR Part 11
,
Audits & Inspections
,
Audit & Inspection-Role
,
Medical Device Inspection
,
Best Practices & GXPs
,
Life Sciences
ISO 14971:2007 -- The Newly Revised Risk Management Standard for Medical Products
Category:
Medical Devices
,
Risk Management
,
All FDA Regulated Industry
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Life Sciences
Hazard Analysis & Risk Management - New 14971
Category:
Medical Devices
,
Risk Management
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Life Sciences
