J. E. Lincoln and Associates LLC

 

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Regulatory Affairs - Quality Systems

Medical Devices - Pharmaceuticals 

- Combination Products

- Dietary Supplements

- Validations

- Product Risk Management

Consulting 

- over 34 years cGMP experience

"Business Success From Regulatory Compliance"™


 

Helping companies to understand

and meet regulatory requirements --

Improved cGMP compliance through...

 

                                                           "Completed Staff Work"(TM)

 

 


Phone 435-840-0252  (use Skype only for prearranged calls)               

E-mail   jel@jelincoln.com

www.jelincoln.com

 

 

TOP 10 FAQ  | ABOUT US  | A TYPICAL PROJECT  | WHY HIRE US?  |  CLIENTS  TESTIMONIALS  |  US FDA QS REG  |  SOFTWARE V&V  |  SOPS/QM 

 NEW PROJECTS  |  PRODUCTS  |  DISCLAIMER  |  ETHICS         

 GUARANTEED CONSULTING 


 

CURRENT  NEWS  LINK(S):       What's Changed With ISO 13485:2016?;

And:        Draft Guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device , released by U.S. FDA August 08, 2016; 

And:        
Draft Guidance on Deciding When to Submit a 510(k) for a Software Change to an Existing Device, released by U.S. FDA August 08, 2016. 

And:       
Draft Guidance on Cybersecurity in Networked Medical Devices, released by U.S. FDA January 22, 2016; 


JOHN'S  FEATURED  WEBINAR:  FDAs New Draft Guidance on Data Integrity for CGMP Compliance; Sep 21, 2016; 12 pm ET, 11 am CT, 10 am MT, 9 am PT; 90 mins.

JOHN'S  NEXT  WORKSHOP:  Verification vs. Validation - Product, Process Software and QMS (21 CFR Part 11); Las Vegas NV; Sep 29-30, 2016.

Visit John's blog on CGMP ISSUES

See John's Profile on LINKEDIN


Site created/updated by John E. Lincoln.

Copyright 1996 - 2016 J. E. Lincoln and Associates LLC.      All rights reserved

                            Site last updated on 08/08/2016.