Master Validation Plan 820.75 & ISO 13485 § 7.5.6 (Executive Series #65)

Links
• GHTF Quality Management Systems - Process Validation Guidance: www.imdrf.org/docs/ghtf/final/...
• 21 CFR 820.75: www.accessdata.fda.gov/script...
• ISO 13485:2016: www.iso.org/standard/59752.html
• Medical Device Single Audit Program (MDSAP) Audit Approach: www.fda.gov/media/87544/download
o Chapter 3: Task 7
o Chapter 6: Tasks 5, 7, 8, 9, 11, 13 & 15
Requirement name and location
Our topic, Master Validation Plan, is used to fulfill the requirements of Process Validation, which come directly from 820.75 and 13485 Section 7.5.6.
Master Validation Plans in 5 words:
List All Processes Validation Status

[@annabanach3987]

really good video, easy to understand ... highly recommend

[@QualitySystemsExplained]

Hi Anna, Thank you! I'm very happy you found the videos helpful. Sincerely, Aaron

[@vijayanandhini5684]

Thanks for the wonderful content. It would be extremely useful if you can provide the answers for your bonus questions as well in the same video :)

[@QualitySystemsExplained]

Thank you for the suggestion! The questions are difficult to answer directly because they require knowledge of the company specific process. :) They are intended to make you curious about your companies processes so you can find the answers as they relate to your company. Best of luck!