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GMPs for API Bulk Manufacturers

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A UL EduNeering course

US Food and Drug Administration-regulated products—food, drugs, biologics, and medical devices—must be created using current good manufacturing practices (cGMPs). Specifically, active pharmaceutical ingredients (APIs) need to be made in accordance with cGMPs. Unlike for medical products, there are no specific US regulations for APIs (although some have been proposed). Until API-specific regulations are finalized, this course reviews how cGMPs can be applied to the manufacture of APIs.

Featured Topics 

  • cGMP requirements for active pharmaceutical ingredient (API) manufacturing personnel
  • GMP requirements for building and facilities
  • cGMP requirements for manufacturing equipment
  • Requirements for materials and packaging components
  • Process controls for APIs
  • Laboratory controls for APIs
  • Record-keeping requirements

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
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Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

Group Discounts\Registration

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

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