820.75 Process Validation including Suppliers

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T "Special Process" Validation Requirements (21 CFR Part 820) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
S 21 CFR 820.75 Process Validation for Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Does a process map satisfy 21 CFR 820.20(d) (Quality Plan)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Calibration of processing equipment - 21 CFR 820.70 Production and process controls 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Interpreting Process Controls - 21 CFR Part 820.70(a) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D 21 CFR 820.80 In-Process Acceptance Criteria requirements for IVDs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Suggested process to show compliance for this 820.120(a) for Label Integrity 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E When to Validate a Process - 21 CFR Part 820.75.(a) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
A Document Review and Document Approval --- 2 Signatures needed acc. §820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A TUV Audits - 21 CFR 820 General Auditing Discussions 6
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
T 21 CFR 820.20 - Quality Planning Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M 21 CFR 820 vs 21CFR820 vs 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
B Per 21CFR 820.198 (b) - Justification for no investigation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 22
K 820.200 Servicing Procedure - Our system (because there is an API involved) is classified as Class 3 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
V Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit ISO 13485:2016 - Medical Device Quality Management Systems 1
R Addressing training requirements - 21 CFR Part 820.25 (1) & (2) Other US Medical Device Regulations 4
R How to improve a Validation program and procedures to FDA (21 CFR part 820) & ISO13485 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q Any good Checklists for ensuring SOPs cover ISO 13485:2016 and 21CFR 820? ISO 13485:2016 - Medical Device Quality Management Systems 3
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
C ISO 13485 certified as precursor to regulatory compliance to 21 CRF Part 820? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
N Change Control - Compliance with FDA 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
D 21 CFR Part 820 (Subpart A) - Question about "Authority" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R RUO audits - CFR 820.22 and ISO 13485 8.2.4 Internal Auditing 3
A Training as well as certifications for ISO 13485:2016, 21 CFR 820... Training - Internal, External, Online and Distance Learning 5
K Production Unit Labeling - 21 CFR 820.184.e 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R 21 CFR Part 820.186 - Types of Quality System Records Document Control Systems, Procedures, Forms and Templates 1
M Does the Scope of 21 CFR Part 820.72 (Equipment) apply to Design? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
V 21 CFR 820 Compliant way to use Kaizen to address Nonconformances Nonconformance and Corrective Action 9
C 21 CFR Part 820.184 - Label Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
shimonv 21 CFR 820.20(d) says: Each manufacturer shall establish a Quality Plan 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
V Upgrading Systems from CFR 211 to CFR 820 (drug+device combination) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 14
Q Internal Audit of Product Quality Complaint System (21 CFR Part 820) Customer Complaints 9
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
R Managing Employee Training Files - 21 CFR Part 820.25 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Release authorization before or after packaging per 21 CFR 820.80(d)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Need advice in streamlining antiquated 21 CFR 820 compliant QMS Quality Manager and Management Related Issues 2
J Minimum staff per 21 CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Issues with UDI additions to 21 CFR 820 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Mapping of IEC 62304 artefacts (SRS, SAD, etc) to the 820.30 phases IEC 62304 - Medical Device Software Life Cycle Processes 5
S How others have defined "reaudits"? 21 CFR Part 820.22 Internal Auditing 1
M FDA 21 CFR 820.250 - Does "valid statistical" always mean math? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6

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