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Pharmaopportunities has the
largest selection of
Introduction To Pharmaceutical cGMP
training courses online. Our training courses are provided by
the some of the best
Biotech
companies in the world.
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| Industry |
Biotech |
| Course Category |
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| Training Location |
90 Minute Accredited Online Training Online Training
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| Training Date and Time |
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| Seating Capacity |
Not Applicable |
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Description |
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Course Schedule - December 11, 2008 at 11:00 a.m. - 12:30 p.m. (EST–New York time)
This 90-minute accredited training course introduces the employee to the cGMP environment. The attendee will gain understanding of the FDA, the Code of Federal Regulations, the reason for the unique laws governing pharmaceutical manufacturing and its role in the pharmaceutical arena.
Module 1:
• The need for the FDA and the cGMP's in our industry
• FDA enforcement
• The “Act”
• Introduction to 21 CFR, Parts 210 and 211
• Case study from the early cGMP history
Module 2:
• CFR 21, Part 210 Definitions
• The index to Part 211
• A brief overview of each section of 211 with examples of
how they relate to job performance
• A case study of how a company uses cGMP's to gain
instructions for improving their performance
Module 3:
• The 7 key areas that are necessary for compliance to the
cGMPs
– Follow good documentation
– Keep it clean
– Follow procedures
– Don't make any unauthorized changes to anything
– Avoid mix-ups
– When in doubt, ask
– The data, record and logs we create doing our job are
critical; The most critical is the batch record
Question and Answer Session |
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Who Should Attend |
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This course will be beneficial to professionals in the pharmaceutical industry especially:
• Employees who need basic cGMP training
• New Hires or Transfers from non cGMP areas
• Employees who have demonstrated a need for retraining
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Click here to Download Brochure
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Click here to View Registration Form |
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