SBS - The best value in QMS software

'Clean' Draft Medical Device Regulations Published

Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
M Classification of Clean Rooms Other Medical Device Related Standards 9
M Are Fungal counts acceptable in class 1000 clean rooms? Other ISO and International Standards and European Regulations 2
Q Clean Line Validation ISO 13485:2016 - Medical Device Quality Management Systems 6
C Clean room injection molding, raw material mixing requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
C Raw material Mixing / Preparation for clean room class C injection molding Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
A Construction of an ISO 8 Clean Room - ISO 14644-1 Manufacturing and Related Processes 2
P ISO 5 Pharmaceutical clean room design Process Maps, Process Mapping and Turtle Diagrams 2
P ISO 7 Clean rooms - Are sinks, faucets, floor drains etc. allowed? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
O Clean room performance qualification (pq) - How many times can I do each test? Manufacturing and Related Processes 8
O Localized clean room dust extraction system coupled in HVAC - Manufacturing solid dosage form Manufacturing and Related Processes 9
I Clean room recovery program Other Medical Device and Orthopedic Related Topics 1
M ISO 7 Clean Room Requirements? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Scarf in Clean Room instead of Hair cover? Manufacturing and Related Processes 8
M What are ISO 7 Clean Room Requirements Manufacturing and Related Processes 0
S Should the primary drug containers be molded in ISO Class 7 clean room? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
S ISO 7 and 8 Clean Room Cleaning Other Medical Device Related Standards 2
S New clean room change submission - FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Sterile Garbage Bag for Clean Room Manufacturing and Related Processes 6
D What should an ISO 14644 Clean Room PQ (Performance Qualification) look like? Manufacturing and Related Processes 3
N ISO 14644-1 Clean Room Occupancy State Validation Requirements Manufacturing and Related Processes 3
R What testing would you run to determine if a device is "Clean"? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S What is the minimum pressure differential required for ISO Class 8 Clean Room? ISO 13485:2016 - Medical Device Quality Management Systems 3
V Not using gloves in Clean Room Class 8 (ISO 14644) Manufacturing and Related Processes 21
C Cotton Swab Method Validation for clean uniforms, bins and poly bags Other Medical Device and Orthopedic Related Topics 4
M Bioburden testing for Class 10000 (Grade C) clean room ISO 13485:2016 - Medical Device Quality Management Systems 1
L How do I set a limits to cfu in an ISO class 7 Clean Room? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Clean Data - Process Duration Using Minitab Software 1
L Clean Room Monitoring Plan Other Medical Device and Orthopedic Related Topics 6
L AS9100 7.5.2 Special Processes - Clean Room Apply? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Clean Test according to ISO 16232 - Some points Other ISO and International Standards and European Regulations 2
G Clean Room Classification for Contact Lens Packaging ISO 13485:2016 - Medical Device Quality Management Systems 4
C How to Clean Gage Blocks and Gage Pins prior to Calibration General Measurement Device and Calibration Topics 4
A Clean Room as a Controlled Environment - Requirements ISO 13485:2016 - Medical Device Quality Management Systems 12
D Do I need to test "as built" for an expanded ISO Class 8 Clean Room ? Other Medical Device Related Standards 2
S What are air changes are required for ISO Class 8 Clean Room? US Food and Drug Administration (FDA) 2
A Clean Room Qualification Regulatory Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
L FDA Inspection of Clean Room Processes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
somashekar Determination of Clean Room Class for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 1
E Do I need to audit the supplier supplying mop heads for our Clean Room ? ISO 13485:2016 - Medical Device Quality Management Systems 8
M What should be in an SOP for a Machine Operation - LAF Bench in our Clean Room ISO 13485:2016 - Medical Device Quality Management Systems 3
P Clean Room Calibration (Validation) Other ISO and International Standards and European Regulations 4
C Recommended Sealing for Granite Top in a Clean Room US Food and Drug Administration (FDA) 1
L ISO 14644 Class 7 Clean Room Requirements Training Presentation Training - Internal, External, Online and Distance Learning 2
drgnrider Suggestions for conducting a Spill Clean-up Exercise Miscellaneous Environmental Standards and EMS Related Discussions 8
T Very effective movie about clean-up - Tool for 5S Training Lean in Manufacturing and Service Industries 4
P How to clean paint area tile faster and improve OEE Manufacturing and Related Processes 3
N Government Help to Clean Up Credit to Buy A House? Coffee Break and Water Cooler Discussions 24
K SPC to apply for Particle in Clean Room Class 100 Statistical Analysis Tools, Techniques and SPC 7
V Updated Clean Room Classification Table of ISO 14644 Other ISO and International Standards and European Regulations 2

Similar threads

Top Bottom