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TRAINING COURSES

Basic Introduction to current Good Manufacturing Practices (GMPs) for Finished Pharmaceuticals

This course is a basic introduction to the FDAs cGMP as applied to the pharmaceutical industry, and focuses on the General Scheme of Quality Systems for pharmaceutical manufacturing. The course is between 1 and 3 hours and also covers FDA history, FDA expectations, as well as industry trends.

Basic Introduction to Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs)

This course is an introduction to FDAs guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.

Basic Introduction to Drug Enforcement Agency (DEA) Controlled Substances Acts

This course is a basic introduction to the DEAs Controlled Substances Act and briefly covers all aspects of controlling and handling of controlled substances.   

Basic Introduction to Quality Systems Inspectional Techniques (QSIT)

This course is a basic introduction to the FDAs medical device compliance program, as well as, emphasizing the systems of: 

  • Management Controls

  • Design Controls

  • Corrective and Preventive Action (CAPA)

  • Production and Process Controls

  • Document Control & Change Controls

Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food

This course is a basic introduction to food GMPs. It covers the following areas of interest:

  • Plants and Grounds

  • Equipment and Utensils

  • Sanitary Facilities and Controls

  • Sanitary Operations

  • Process and Controls

Basic Introduction to Importing Foods into the United States

This course covers the basic procedures for importing foods into the United States. It also covers aspects of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act)

Combat Methamphetamine Epidemic Act of 2005

 

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