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Unless otherwise indicated, our webinars focus on basic to intermediate material.
This is because the multimillion dollar fines, the countless GMP compliance audit
FDA Form 483 observations, even the Justice Department actions against regulated
companies have almost always been due to failure to adhere consistently
to the basics. This is in spite of their employing highly trained / educated /
paid staff and consultants.
The secrets to successful compliance lie not in exotic new ideas, but in
consistently implementing straight-forward regulatory systems that provide
individual leeway while meeting US FDA requirements as they grow and change
over time.
YOUR INSTRUCTOR:
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 of which 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, Technical Documentation Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer-reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. See his four chapters in the new 2nd edition RAPs book, "The Medical Device Validation Handbook". John is a graduate of UCLA.
Past Webinars (available "company-customized"):
o DHF, DMR, DHR, Technical Documentation Per US FDA CGMPs and
EU MDR Requirements
o Good Clinical Practices and Good Laboratory Practices
o 21 CFR Part 11, “Electronic Records
and/or Electronic Signatures
o Validations: Product, Production Equipment, Process, Molding
o Master Verification and Validation
Planning – Product, Process / Equipment,
Software
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Mobile Health Apps snd the FDA
o Change Control – Company and Suppliers
o Management Responsibility; Management Review
o Design / Change Control; Design History Files (DHF)
o Risk Management of Medical Devices (ISO 14971)
o Corrective and Preventative Action (CAPA)/Failure Investigation
o NDAs, IDAs, and the Drug CGMPs
o ISO 13485:2016 (ISO 13488, EN 46001) and ISO 9001:2000 Familiarization
o Production and Process Control (P&PC)
o Project/Program Management (PERT/CPM, Gantt)
o Preparing a 510(k) Premarket Notification: The Three Approaches
o Changes and the 510(k) -- Device Hardware and Software Requirements
o Design History Files / Device Master Records / Technical
Files / Design Dossiers
o SPC (Statistical Process Control)
/ Control Charts
o QSIT (FDA's Quality System Inspection Technique
– Medical Devices)
o The Quality System Regulation (cGMP, 21 CFR 210 & 211 and 820)
o Reduced Product Cycle Time -- 'Time-to-Market' – Reduction
o Technical Writing for Technical Personnel (In a Regulated Industry)
If you don't see a title above that you need CONTACT US, and we may have it or can create it.
These workshops are facilitated by John E. Lincoln, principal consultant,
J. E. Lincoln and Associates LLC
Medical Devices / Pharmaceuticals / Dietary
Supplements / QA / RA
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Last updated: 04/13/2023
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