HOMEWORK ASSIGNMENT 4 PATHWAY FOR PATIENT HEALTHGLOBAL REGULATORY AND LEGAL REQUIREMENTS OF QUALITY

Описание: HOMEWORK ASSIGNMENT 4 PATHWAY FOR PATIENT HEALTH GLOBAL REGULATORY AND LEGAL REQUIREMENTS OF QUALITY Assignment:
1) Step 1: You will need to listen to the “Failure Investigations” class in order to successfully complete this assignment. A failure investigation assist document has been provided as a handout to explain the various sections of the failure investigation template. This was also reviewed during the class recording.
2) Step 2: Complete the Failure investigation template provided at the end of this document using the information in the Scenario Section of this Homework Assignment.
a) In the “Root Cause Investigation” Section of the Investigation Report:
i) Write at least 5 observations of failure, and why these are viewed as failures to comply with federal regulations and/or GMP expectations (failures to comply with regulations and expectations)
ii) Link the 5 observations to relevant GMP requirements (specific 21CFR211 references). For each of your 5 observations, please list the CFR number and the title of that section, such as “21 CFR 211.100 – Written procedures; deviations”.
iii) Provide a description of how each observation could be potential sources of contamination and/or risk. ✅ Seek help; https://getbrainful.com