Preparing for an FDA Inspection in IT operations
Notre partenaire américain, Johnny GUERRA, ex-membre de la FDA organise le 22 mars 2013 de 15h à 17h30 un Webinar en anglais de deux heures sur le thème "comment préparer une inspection informatique FDA sous l'angle documentaire".
Les sujets suivants seront abordés :
- Business vs. cGMP activities.
- FDA and the Predicate Rule: Code of Federal Regulations (CFR) and cGMP
Tools of the trade in IT operations:
- FDA Guidelines, FDA Inspection Guides, FDA Compliance Programs, FDA Policy Statements, IOM, and others
IT and cGMPs:
- How much regulatory knowledge is required?
- Key cGMP regulations impacting IT operations: 21 CFR 210, 21 CFR 211 and others.
IT Activities supporting cGMP operations:
- A cGMP approach to Data Accuracy, Data Integrity and Data Security.
- Computer System Validation (CSV) in manufacturing and laboratory operations.
- An FDA approach to “Off-The-Shelf Software” auditing.
- Part 11; Electronic Records; Electronic Signatures.
- Current FDA enforcement strategies under Part 11:
- FDA Guidance for Industry: “Scope and Application.”
- FDA enforcement discretion.
- Part 11 Inspection Challenges: FDA and “Cloud Computing.”
Presenting the documentation to FDA investigators:
- What FDA investigators will ask for during the inspection?
- How to manage the FDA inspection from an IT perspective:
- Due diligence: What to do before inspections?
- Do's and Don’ts during the inspection.
- Following an FDA-483 and/or Warning Letter: IT responsibilities
Objectionable observations taken from FDA-483 and Warning letters:
- What was the problem? How IT was impacted?
- How could it have been avoided?
Les participants à ce séminaire disposeront d'un certificat de formation de la part de Johnny GUERRA ; Un minimum de 5 participants est nécessaire pour que le webinar soit réalisé.
Le coût d'inscription individuel à ce webinar est de 250€.
Pour vous inscrire :
Par mail
Par téléphone : +33 681 325 747
