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FDA 21 CFR Part 820 Quality system Regulation | Operon Strategist

operon strategist provide FDA 21 CFR Part 820 Quality System Regulation Consultant Services For Medical Device Manufacturers. FDA QSR, GMP Guidelines, FDA(510k), CE Mark Regulatory<br>Contact details u2013 <br>Phone no - 9325283428<br>Mail - dm@operonstrategist.com<br>Visit us u2013 https://www.operonstrategist.com/21-cfr-part-820-quality-system-regulation/#utm_source=ppt pdf submission&utm_medium=ppt pdf page&utm_campaign=ppt pdf submission<br>

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FDA 21 CFR Part 820 Quality system Regulation | Operon Strategist

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  1. US FDA 21 CFR Part 820 Quality System Regulation https://www.operonstrategist.com/21-cfr-part-820-quality-system-regulation/

  2. US FDA 21 CFR Part 820 Quality System Regulation US FDA Part 820 covers the processes used in, & the facilities & controls used for the design, manufacture, packaging, labelling, storage, installation & servicing of medical devices.

  3. Management Commitment & Continual Improvement Personnel Training and Competency Risk Management GMP Quality System Management Product Control Site and Facilities Management

  4. The FDA 21 CFR part 820 also known as Quality System Regulation QSR which outlines current good manufacturing practice (CGMP) regulations that control the techniques used in and the efficiency and controls used for, the manufacturing , labeling , packaging , storage, installation, design, and servicing of all finished medical devices predetermined for human use and marketing in the United States Of America.

  5. Operon Strategist does an initial gap analysis of the existing system to determine the extent of development of the quality system. We provide 21 CFR 820 training in which we guide the clients through documentation & help them to effectively implement it through the various functions of the company. We also conduct a mock audit to test the effectiveness of the implementation of Part 820 requirements. We also provide post-inspection guidance to clients to help them close any non- conformance observed during the audit.

  6. Thank You. For More Information Contact Us www.operonstrategist.com info@operonstrategist.com +91-9325283428

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