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Course Details
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Course Title:
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Good Documentation Practices
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Description:
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This course will provide attendees with a background in Good Documentation Practices (GDPs) as applied to pharmaceutical research. This course will emphasize GDP requirements, responsibilities, standards and regulatory perspectives (e.g., FDA).
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Objectives:
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Upon completion of this course, participants should be able to:
- Describe law and regulatory requirements for documentation for the pharmaceutical industry
- Discuss the overall concept of Good Documentation Practices and responsibilities
- Identify risks associated with non-conformance
- Outline steps to take to improve documentation practices
- Summarize FDAs Expectations regarding GDPs.
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Course Contact:
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