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Part 11: Electronic Records; Electronic Signatures

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Overview 

A UL EduNeering course

The principal purpose of 21 CFR Part 11 is to ensure that when electronic records and signatures are used, they meet the minimum requirements of trustworthiness, reliability, and compatibility with FDA’s mission of public health and safety.
This interactive lesson is designed to introduce you to the regulatory requirements for electronic records and electronic signatures, as well as FDA expectations for compliance. You will learn specific Part 11 requirements that govern the use of electronic records and signatures as well as FDA enforcement of Part 11.

Featured Topics 

  • Part 11
  • Basic and security requirements for electronic records
  • Basic requirements for electronic signatures
  • Controls for electronic signatures
  • FDA enforcement of Part 11

Who Should Attend 

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Special Offers 

Save by purchasing multiple UL EduNeering eLearning modules at one time. One to two modules cost $99 each, three to four cost $89 each, five to nine cost $80 each, and 10 or more cost $65 each.

Contact Information 

Linda Belmont, DIA
Phone +1.215.293.5818
Linda.Belmont@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

Individual
$99.00
Group Discounts

When purchasing multiple UL EduNeering eLearning modules in one transaction, the following discount prices apply:

·          1 to 2 modules are $99.00 each

·          3 to 4 modules are $89.00 each

·          5 to 9 modules are $80.00 each

·          10 or more modules are $65.00 each

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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