ABE 512: Good Regulatory Practices

0 or 3 credits

Spring 2023 Distance Learning Departmental CreditUpper Division
Data from
Spring 2023
last updated 8/23/2024

Includes a review of the FDA and ICH regulations on good manufacturing, good laboratory, good clinical practices. The meaning of these regulations, the globalization of practices and the roles and responsibilities of various professionals implementing these regulations will be addressed. Special emphasis will be detailed coverage of the process for the assembly and submission of an IND or NDA, and the function of the regulatory affairs department in a pharmaceutical company.

Course ABE 512 from Purdue University - West Lafayette.

Prerequisites

One of
Student attribute GR

Restrictions

Students of Graduate, College of Pharmacy or Doctor of Pharmacy
NOJuniors (60-74 credits), Sophomores (30-44 credits), Sophomores (45-59 credit...show more

GPA by professor

Kari...(Spring 2021)
3.9

Community

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ABE 512: Good Regulatory Practices