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Understanding Post-Approval Changes

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Overview 

A UL EduNeering course

This course covers the definition and purpose of post-approval changes (PAC). It explores the four categories of change—components and composition, scale of manufacture, site of manufacture, and manufacturing—and the requirements for each level of change. Participants will learn about PAC guidance and how these documents are used to notify the US Food and Drug Administration (FDA) of changes to an approved pharmaceutical application. The course also covers the levels of post-approval changes and the recommended chemistry, manufacturing, and control requirements for each level.

Featured Topics 

  • Defining post-approval changes
  • Four categories of change
  • PAC guidance documents

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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