J. E. Lincoln and Associates LLC
is a regulatory management consulting company specializing in regulatory affairs and quality issues
pertaining to medical devices, pharmaceuticals / drugs, and dietary supplements / neutraceuticals.
John E. Lincoln, principal consultant, has worked over 41 years in U.S. FDA-regulated industries, especially
medical devices; in engineering/product development, quality and regulatory affairs. We are now in our
tenth year as an independent consulting organization. We assist companies from start-ups to Fortune 100 / global
multinationals in the following:
ENGINEERING (product, manufacturing and quality):
o New product and/or process development o
Verification and validation (equip., process, software) ;
o DOE (design of experiments);
o Defect identification, testing, reduction
o Flow charting/process mapping
o Risk analysis (ISO 14971), FTA, FMEA, FMCEA, HACCP, Fishbone diagramming, Pareto
o Materials/plastics --
Component specifications o Packaging -- Sterilization
QUALITY SYSTEMS:
o 6-sigma; 7 basic quality tools; SPC/control charts; defects per million
o ISO 13485, and ISO 9001compliant systems implementation
o Quality Manuals -- Technical Files
/ Design Dossiers -- Design History Files
o Nonconformances -- Trending -- Complaint Systems
o Root Cause Analysis
o Sampling plans; C=0,
ANSI/ASQ Z1.4 (Mil Std 105E)
REGULATORY -- Domestic and International:
o 510(k) submission (3 options: Traditional, Special,
Abbreviated)
o Quality System Regulation, Title 21 CFR Part 820 (cGMPs) o Design control -- Change control o MDR's -- MedWatch; post-market surveilance -- Regulatory responses
o Complaint investigations and responses -- Recall programs/coordination
o Title 21 CFR Part 210, 211 (Pharma);
111 (Dietary Supplements) o Title 21 CFR Part 11 (Electronic Records/Signatures); Title 21 CFR Part 4 (Combination Products)
ALL DISCIPLINES:
o Verifications and Validations (IQ, OQ, PQ); Reuse of SUDs
o Software V&V a speciality (in-product, as-product, process, QMS;
the 11 Elements)
o SOP/Work instruction development
o Technical manuals
o Project history files
o Teams (Productivity enhancement, defect reduction...)
o Training -- Product, process, QS Regs., 6-sigma, Safety/OSHA/chemical hazards o MSDS's
o Internal and vendor audits
o FDA responses
o Coaching - individual or team; any of the above as well as "soft skills" (appearance, voice, presentation...)
We fulfill short and long term assignments, with firm proposals
/ price quotes prior to start.
No charge for initial consultation.
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