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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 FDA’s 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 FDA’s 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 DEA’s
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 FDA’s medical device
compliance program, as well
as, emphasizing the systems
of:
-
Management Controls
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Design
Controls
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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:
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 |
