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Unless otherwise indicated, our workshops focus on the basics.
For this we have sometimes been criticized.
However, the multimillion dollar fines, the countless GMP compliance audit
U.S.
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.
o "Regulatory Leadership Bootcamp" -- Leadership in an FDA-
Regulated Company: Team coaching;
Individual coaching also available
o Software Validation: in-/as-product, process, system/QMS/ERP
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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Vision Systems, Clean Rooms/Hoods, Reuse of SUDs...
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 HACCP (FDA's Hazard Analysis of Critical Control Points)
o ISO 13485:2003 (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); K97-1 Usage
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)
o Coaching: Private / phone and/or group
Note: Additional or custom subjects available on request...
the majority of 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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