Your event should be here ! To publish, manage, promote... To learn or to be formed ... Online registrations

Site language : English - Français
Ref : 29288
Event :FDA 21 CFR Part 11 Compliance: Streamline Your Transition to Electronic Records

Date :Tuesday April 16th, 2019

Location :Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016
80016-6104 Aurora, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

 

OVERVIEW

FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient.

FDA has set up regulations that address both data security and patient safety. We will show how FDA 21 CFR Part 11 compliance checklist considers both.

The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained. FDA requirements for electronic record and signature validation will be explained. The requirements are composed of technical and procedural aspects. Open, closed and hybrid (paper and electronic) systems will be explained.

WHY SHOULD YOU ATTEND

Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11.

After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would “selectively enforce” sections of the regulation. This webinar will explain what all of this mean.

An FDA 21 CFR Part 11 compliance checklist and a test protocol form will be given as handouts.

AREAS COVERED

  • Origin of the FDA regulation and changes in interpretation
  • Electronic records
  • CFR electronic signature
  • Data security
  • Open, closed and hybrid systems
  • Validation methods
  • Risk analysis

LEARNING OBJECTIVES

This webinar will explain what FDA 21 CFR Part 11 compliance is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Procedures for controlling electronic signatures and electronic records as described in the FDA regulation will be explained.

WHO WILL BENEFIT

  • Engineering personnel
  • QA 
  • IT
  • Management
  • Compliance Officers

 

Use Promo Code MKT10N and get flat 10% discount on all purchases

For more detail please click on this below link:

http://tinyurl.com/y2b5udg4

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

 


Location

Map and directions
Conference address :
Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016
80016-6104 Aurora
United States
tel : 7209961616
Map and directions

Further information

To access the information you need to be connected. Creating an account is easy and free!

Log to your account
Register on Doctorama

Details

FDA 21 CFR Part 11 Compliance: Streamline Your Transition to Electronic Records Pharmacy
21 cfr part 11 conformance for medical devices, electronic record and signature validation, 21 cfr part 11 compliance
Professionals
20 1 --
English

Other

For more information on FDA 21 CFR Part 11 Compliance: Streamline Your Transition to Electronic Records, plsase contactr Training Doyens

To obtain a letter of invitation, you must be logged

Log to my account
Register on Doctorama


Recommend this event