See / hear / read about John at the following venues:

 

 

Institute of Validation Technology

Compliance On-Line

Global Compliance Panel

LinkedIn Profile

 

Seminar / Workshop Titles:

(available off- or on-site)



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         

o  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

 

CONTACT US

 

 

Check out our GMP Training website for some additional information, at

www.gmp-trainingcourses.com

 

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                                                                                                                  Last updated on 02/12/2013.