Sample FDA compliant CAPA procedure wanted

P

patilrahuld

Starting to get Involved
#1
#1
Hello,

Can anyone please share their CAPA procedure with me. We are in a process of getting FDA registered and wanted to update our corrective action procedure more in line with FDA requirements.

Appreciate the help in advance.

RDP
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Y

yodon

Staff member
Super Moderator
#3
#3
I would expect that this post hasn't gotten any reaction for several reasons. For one, CAPA has been a long-standing leading cause of 483s. So maybe most folks are either worried about sharing something that might not be compliant or holding close something that has demonstrated compliance.

In your case, since you already have a CAPA procedure, why do you think yours isn't up to FDA snuff?

I presume you've read the regulation? You can find it here: http://www.ecfr.gov/cgi-bin/text-idx?SID=771895e57a8d34e12db0146c85122b79&node=sp21.8.820.j&rgn=div6

You can also get some information on what inspectors are taught to look for when reviewing your operations through the QSIT publication. Here's the link to the CAPA section: http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170612.htm

Maybe after going through all that, you can post some specific questions. Those typically get more traction.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
P Sample of an end-use-letter for drugs according to FDA requirements US Food and Drug Administration (FDA) 2
Q Determining Sample Size for FDA Verification and Validation Activities Inspection, Prints (Drawings), Testing, Sampling and Related Topics 41
H Sample Design Plan that complies with FDA QSR, ISO 13485 & 14971. ISO 14971 - Medical Device Risk Management 5
Y FMEA link to Control Plan frequency and sample size FMEA and Control Plans 19
T Noob question regarding sample size Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
S Help needed in choosing the method of calculating the minimum sample size Internal Auditing 12
P Worst case HLD sample for efficacy studies Other US Medical Device Regulations 0
D Estimate Sample Size for very rare event Using Minitab Software 1
M Summative evaluation: how many sample per participant? IEC 62366 - Medical Device Usability Engineering 5
S Determining Sample Size and Method Quality Tools, Improvement and Analysis 11
C Complaint Return Sample Size Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
shimonv Frequency and sample size for lot release of EtO sterilized products EU Medical Device Regulations 2
X Sample SOC2 audit report (or a redacted one) IEC 27001 - Information Security Management Systems (ISMS) 0
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
M Sample record for verification performed by importers before placing a device on the market EU Medical Device Regulations 0
P Sample Size for Distribution Simulation Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 4
G Where to buy Template / sample SCSMS Manual, checklist Supply Chain Security Management Systems 1
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
K How can Acceptance Number and Reject Number be larger than Sample Size on Z1.4 Table? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
P MSA - what exactly mean "system" and master sample Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
J Validation Sample Size for Tray Seal Qualification and Validation (including 21 CFR Part 11) 4
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
S Determining sample sizes for PQ Qualification and Validation (including 21 CFR Part 11) 4
M Minimum sample size - Guidance and statistical rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
D Adding a Class I to a sample box Canada Medical Device Regulations 5
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 41
M ISO 9001:2015 case study sample ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Sample of Nonconformity report for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
B Control chart and sample time Statistical Analysis Tools, Techniques and SPC 1
J Control chart for huge sample size Statistical Analysis Tools, Techniques and SPC 9
D How to list multi-product sample pack in GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Is there a standard for sample size during R&D phase Other ISO and International Standards and European Regulations 18
M Minitab assistant: 1-Sample % Defective Test Using Minitab Software 1
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
T ISO 27001 sample audit report IEC 27001 - Information Security Management Systems (ISMS) 5
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
D Sample Calibration SOP for ISO 13485 General Measurement Device and Calibration Topics 4
T Sample of 1st Article Inspection Report wanted APQP and PPAP 3
E Correct way to certify hydrostatic testing when it is not 100% (and Sample Size) Various Other Specifications, Standards, and related Requirements 6
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
B Determining sample size for device sterility Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A In which EU countries would it be okay to use sample labels for registration? EU Medical Device Regulations 0
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 5
F Bayes Success run Theorem for sample size during OQ&PQ Qualification and Validation (including 21 CFR Part 11) 4
Watchcat Identification of Test Sample in Test Reports? Design and Development of Products and Processes 22
M AQL table - I need to sample 1250pcs AQL - Acceptable Quality Level 3
K The correct way of doing a 2 Sample T test Reliability Analysis - Predictions, Testing and Standards 7

Similar threads

Top Bottom