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Part 11: Electronic Records and Signatures - Application

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Overview 

A UL EduNeering course

This course will provide the learner with an understanding of how to implement Part 11 and what it means in terms of FDA’s enforcement policy for 21 CFR Part 11, Electronic Records; Electronic Signatures.  The course discusses the Guidance for Industry; Part 11, Electronic Records; Electronic Signatures – Scope and Application, August 2003.

Featured Topics 

  • Identify steps to prepare for an inspection
  • Security
  • Electronic signatures
  • System documentation
  • Audit trails

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
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