Module 14 2022

14/03/2022

Design and Development Planning

21 CFR 820.30( b )

(b) Each manufacturer shall establish …. plans that describe …. activities and define responsibility ….. groups that…. input to the design and development process. The plans shall be reviewed , updated , and approved …

The Organisation for Professionals in Regulatory Affairs

15

Design and Development Planning

The Organisation for Professionals in Regulatory Affairs

16

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