The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm - Medtech Insight

• FDA GMP QSR cGMP Online Training - popular GMP online training courses provided by SkillsPlus International Inc. 

According to the article:

"Executive Summary

From our archives: Despite the COVID-19 pandemic severely curtailing the US FDA’s ability to conduct on-site facility inspections, it’s still vitally important for manufacturers to remain audit-ready. In this collection of a 10-part Compliance Corner series, four longtime industry experts share evergreen advice on the best and worst things firms could do during an inspection."

Read the full source article:  The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm - Medtech Insight

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FDA Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation - Medtech Insight

• FDA cGMP QSR GMP Online Training - respected GMP online training courses offered by SkillsPlus International Inc.

Updated March 4, 2021

FDA Misses Fifth Target Date For Issuing Draft Harmonized Quality System Reg - Medtech Insight

---  original post follows below  ---

According to the article:

"February 2021 is the latest target date selected by the US agency for releasing a draft of its retooled QSR, which has been undergoing a facelift for more than two years to harmonize it with international quality systems standard ISO 13485.  ...

This is the fifth in-house deadline the FDA has set for issuing its draft rule, which will harmonize the QSR with international quality systems standard ISO 13485:2016. The agency had previously set deadlines of April 2019, September 2019, April 2020 and October 2020."

Read the full article:  FDA Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation - Medtech Insight

Return to SkillsPlus International Info Blog - Home

-----------

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!