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FDA Inspection and Respond to 483 & How to Prepare them - 2017

Du Mardi 08 Août 2017 au Mardi 08 Août 2017 à CA
A partir de: 10:00
Secteurs concernés: Biomedical -
DESCRIPTION
Overview:
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection.

Why should you Attend:
FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.

Areas Covered in the Session:
Personnel Preparation
Facility needed to support inspection
Behavior during inspection-what not to sign
Internal/ Mock audits
483 response

Who Will Benefit:
Engineering Personnel
Engineering Management
Quality Management
Corporate Management
Manufacturing Management
Division Management

Speaker Profile:
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
PUBLIC, SECTEURS, ACCREDITATION
Accréditations : 0
Public concerné: Tous
Audience: Internationnale
Visiteurs/Participants: 100
Conférenciers: n.r
Exposants: n.r
Type d'événement: Congrès
Secteur principal: BIOMEDICAL
Secteurs concernés: Biomedical -
ORGANISATEUR / ANNONCEUR

COMPLIANCE4ALL

161 Mission Falls Lane, Suite 216,
94539 Fremont
UNITED STATES

COMMENT
REFERENCE
Congrès, formations ou conférences médicales REF #28-7484
FDA Inspection and Respond to 483 & How to Prepare them - 2017
Publié sur congres-medical.com le : 2017-06-30 12:16:38
Congrès, formations ou conférences médicales en BIOMEDICAL
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