Does any one have FDA 21 CFR Part 820 QSR training material?

Sidney Vianna

Post Responsibly
Staff member
Admin
#11
The entry point is https://www.fda.gov/media/82916/download.

For the QSR presentation materials, peruse

Overview of the Quality System

Start Here! Overview of the Quality System (New module 11/19/18)
PresentationExternal Link Disclaimer Printable Slides Transcript

Production and Process Controls (New module 11/19/18)
PresentationExternal Link Disclaimer Printable Slides Transcript

Documents, Change Control, and Records (New module 11/19/18)
PresentationExternal Link Disclaimer Printable Slides Transcript

Design Controls
PresentationExternal Link Disclaimer Printable Slides Transcript

Management Controls
PresentationExternal Link Disclaimer Printable Slides Transcript

Purchasing Controls
PresentationExternal Link Disclaimer Printable Slides Transcript

Process Validation
PresentationExternal Link Disclaimer Printable Slides Transcript

Corrective and Preventive Actions
PresentationExternal Link Disclaimer Printable Slides Transcript

Nonconforming Product
PresentationExternal Link Disclaimer Printable Slides Transcript

Complaint Files
PresentationExternal Link Disclaimer Printable Slides Transcript
 
Elsmar Forum Sponsor

blah01

Involved In Discussions
#13
Does part 820 (or eventually ISO 13485) apply to Class I devices?
So to answer my own question from an earlier post if Part 820 applies to Class I devices, the answer is ...it depends...

Per the "Medical Device Exemptions 510(k) and Device Listing" page (link), it identifies Class I devices that are GMP (i.e. Part 820) exempt, which depends on the product sub-category. You basically have to figure out your product category and sub-category and look up the details on that sub-category and it will indicate if it is GMP exempt or not. For example, 886.5910 is GMP exempt.

Just posting this in case it helps anyone.
 
Thread starter Similar threads Forum Replies Date
M FDA 21 CFR 820.250 - Does "valid statistical" always mean math? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S Does FDA expect suppliers to be independently assessed to 21 CFR Part 820 ? US Food and Drug Administration (FDA) 4
A What does the FDA think about 13485? Will the FDA upgrade 21 CFR 820? ISO 13485:2016 - Medical Device Quality Management Systems 3
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
William55401 How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
P Warning Letter 1999 - Where does the FDA make older warning letters available? US Food and Drug Administration (FDA) 4
supadrai How does the FDA count violations of, for example, misbranding? (Medical Devices) Other US Medical Device Regulations 1
K Where does the FDA post its various compliance dates? US Food and Drug Administration (FDA) 2
R FDA 510K - Does the FDA accept the testing report from other countries? Other US Medical Device Regulations 1
N Does FDA allow comparing with the competitors Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I 510k Performance Testing Studies (Raw Data) - What does the FDA expect 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q When does the FDA deem something "where appropriate"? 21CFR820.30(g) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
B How does a Kit Assembler proceed after FDA Establishment Registration? Other US Medical Device Regulations 3
R Does FDA allow e-labeling? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Y FDA - Does anyone have conduct the validation on GR&R worksheet before? Qualification and Validation (including 21 CFR Part 11) 7
K What liability does the QA Manager/Management Rep hold? (US FDA environment) Career and Occupation Discussions 4
AnaMariaVR2 St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues US Food and Drug Administration (FDA) 5
R Does FDA require monitoring competitor device failures for preventive action? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B Does a US FDA Class I (exempt) device require a Statement of Intended Use? Other US Medical Device Regulations 3
D Will buyers (hospitals) require IEC 60601, even when FDA does not? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Does FDA cGMP apply to Laboratory Equipment? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Medical Device Malfunction during misuse - Does this need to be reported to the FDA? Other US Medical Device Regulations 5
D DHF Review - When does the FDA review the DHF? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Does Canada have an equivalent to FDA preIDE meeting? Canada Medical Device Regulations 4
A How long does it take US FDA to issue a Warning Letter Close Out Letter Other US Medical Device Regulations 2
R First MDR (Medical Device Report) - Does the FDA give feedback? US Food and Drug Administration (FDA) 4
Y Does FDA have regulations about Braille use for Medical Device Other US Medical Device Regulations 2
T Does FDA consider Flow Charts sufficient instruction for SOPs? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E Does the US FDA issue GMP certificates? Other US Medical Device Regulations 2
M Does a dental handpiece need FDA permission? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Q FDA Inspector - What does it take to become an FDA inspector? US Food and Drug Administration (FDA) 4
E Does European Manufacturer with ISO 13485 need QSR820 for FDA registration? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Does FDA change the information about" wire transfer" US Food and Drug Administration (FDA) 1
S Does anyone know if ISO publishes audit findings/results much like the FDA ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M Does FDA allow you to withdraw a CAR once it is in your system Nonconformance and Corrective Action 3
I 510k Approval - Does the FDA look for Clinical Data 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S How often does the FDA inspect organisations outside of the USA? US Food and Drug Administration (FDA) 12
T Submission of 510(k) - Does the FDA require a predefined structure of the content? ISO 13485:2016 - Medical Device Quality Management Systems 2
S FDA Validation - Does one have to conduct validation for Computer Servers? Qualification and Validation (including 21 CFR Part 11) 8
G Does The FDA oppose the use of Process Flow Charts? ISO 13485:2016 - Medical Device Quality Management Systems 8
P How does the FDA's SMG 2020 compare to ISO/TR 10013:2001? US Food and Drug Administration (FDA) 2
R Does anyone have any information on FDA's SMG 2020 issued Oct 04. US Food and Drug Administration (FDA) 1
L CE Mark - FDA - Class I traction systems - What is involved and how long does it take EU Medical Device Regulations 5
Q FDA Establishment Registration - Does registration require compliance to the QSR? ISO 13485:2016 - Medical Device Quality Management Systems 8
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
Similar threads


















































Top Bottom