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Langue du site : Français - English
Réf : 30362
Evènement :Avoid Documentation 'Time Bombs'

Date :Mercredi 11 Septembre 2019

Lieu :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, California, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

This documentation training will explain regulatory ramification of communication done through Lab books, SOPs, DHF, technical files etc and how to reduce it.

Objectives

Lab books, project and design history files, correspondence including e-mails, websites, and marketing literature may all contain information that can compromise a company and it's regulatory compliance. Major problems with the U.S. FDA and/or in lawsuits have resulted from careless or inappropriate comments or even inaccurrate opinions being "voiced" by employees in controlled or retained documents. Opinionated or accusatory E-mails have been written and sent, where even if deleted, still remain in the public domain where they can effectively "last forever".

In this electronic age of My Space, Face Book, Linked In, Twitter, Blogs and similar instant communication, derogatory information about a company and its products can be published worldwide, and "go viral", whether based on fact or not. Today one's 'opinion' carries the same weight as 'fact'.

But do companies and their employees realize:

  • How long lasting such communication really is; and
  • The regulatory ramifications of such communications. Even the older, hard copy documentation may contain hidden landmines: Lab books, SOPs, drawings and specifications, project and design history files and even technical files / design dossiers. What are such "landmines"? How can they be reduced? Why should companies / employees care?

Attend this documentation training to know the answers to above questions.

 

 

Program

  • The problems.
  • Electronic "eternity".
  • Hard copy headaches.
  • Regulatory issues.
  • Potential legal issues for non-lawyers.
  • Solving the problem - steps to take.
  • Monitoring effectiveness -- integration of corrective / preventive action.

 

Speakers

John E Lincoln
Principal, J E Lincoln and Associates

Lieu

Plan et itinéraire
Adresse de la conférence :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire

Renseignements

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Précisions

Avoid Documentation 'Time Bombs' Management
"documentation training, lab books, sops, dhf, technical files, fda regulations, drawings, specifications
Professionnels, This webinar will provide valuable assistance to all regulated companies that need to be aware of the pitfalls of careless, "stream of consciousness" in appropriate conversation and electronic or written opinions. Once recognizing the danger and likely locations, Then putting in place the necessary policies and training to minimize their occurrence. This information applies to personnel / companies in the Medical Device, Diagnostic, And Biologics fields. The employees who will benefit include: Senior management Regulatory Affairs Quality Assurance Production Engineering All personnel involved in documentation or having access to e-mail / the Internet
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English

Divers

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