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1-Compare ISO 9001, 21 CFR 820, and 21 CFR 210-211 and justify your analysis with references....

1-Compare ISO 9001, 21 CFR 820, and 21 CFR 210-211 and justify your analysis with references.

I just need a quick explanation of them. I already defined them but feel free to defined them and explain in simple terms what they are used for.

Subject is Quality.

business   Operations-Management   
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Answer #1

ISO 9001:- 9001 is the International Standard for Quality Management Systems

21 CFR Part 820:- Ensures Your Device is safe and effective, the purpose of regulatory affairs is to ensure complies with applicable laws and regulations. These regulations, such as Quality System Regulation 21 CFR Part 820, are intended to ensure devices entering the marketplace are safe and effective.

21 CFR 210-211:- In the 21 CFR Part 210 and 211, 21 CFR Part 210 deals with the Manufacturing, Processing, Packaging or Holding of drugs, while 21 CFR Part 211 deals with finished pharmaceuticals.

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