Upcomining Webinars:


Webinar Number: / Title

CONDUCTING   REMOTE   CGMP   INSPECTIONS   DURING   COVID-19

PER US FDA CGMPs and EU ISO

-- New and Expanded Webinar Content


o CGMP Requirements; EU / ISO Requirements

o Typical CGMP Inspection Criteria

o Internal and Vendor Inspections / Audits

o Remote Audit / Inspection Preparation

o Remote Audit / Inspection Techniques

o The Remote "Tour"

o Remote Documentation Review

o Remote Meetings

o Test Report / Protocol structure

o Q&A - no time limit post-webinar

o CEUs = 0.15



90 minute presentation, including Q&A

Wednesday, November 25, 2020, 10:00 AM PDT, 01:00 PM EDT

$249.00 (USD) for dial-in for one attendee at one location

 



$649.00 (USD) for up to 10 attendees at one dial-in location

 



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 38 years experience in U.S. FDA-regulated industries, 24 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  "Regulatory Leadership Bootcamp" -- Leadership in an FDA-Regulated          

    Company:  Team coaching;  
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 13485:2016 (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: 10/13/2020