Pharmaceuticals News Transdermal and Topical Delivery Systems: FDA & EMA Guidance

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V Template / format for Device History File & Design Verification of transdermal patch 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
Jim Wynne Some topical humor Funny Stuff - Jokes and Humour 4
A CTD (Common Technical Document) for a Topical Preparation Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
B Is a Topical Antiseptic a Physical Mode of Action? EU Medical Device Regulations 2
D Zinc Oxide as a Topical Application EU Medical Device Regulations 4
M Topical Anesthetic for Dental use - Where to start to get it registered? Other US Medical Device Regulations 10
A Specifications or guideline for topical patch medical device ISO 13485:2016 - Medical Device Quality Management Systems 6
A Traceability unequal lots/batches delivery production IATF 16949 - Automotive Quality Systems Standard 8
S On-time delivery CRITERIA AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
L On Time Delivery - what percentage is the norm? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 28
Q Customer Satisfaction through On-Time Delivery ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
qualprod On Time Delivery KPI for sales? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
DuncanGibbons Why is 8.4 post-delivery activities before 8.6 release of products and services in AS9100D? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Medical Device Initial Importer (DII) Requirements - Delivery Address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D Delivery Schedule Performance - IATF 16949 Cl. 9.1.2.1-d IATF 16949 - Automotive Quality Systems Standard 3
N Where I can find an Excel sample/template for recording Delivery Time and Cost Excel .xls Spreadsheet Templates and Tools 2
Y What Clinical Data is required for Drug Delivery System EU Medical Device Regulations 1
Pmarszal Delivery Confirmation? Do we need to save? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B AS9100 Scope of Registration - Post-Delivery Activities N/A? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
K What can be considered a "Post Delivery Activity" (ISO 9001:2015 Clause 8.5) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
W Business Procedure/Service Delivery Procedure Design and Development of Products and Processes 8
S Boss wants customer delivery signature specimen form Customer and Company Specific Requirements 16
L OTD (On Time Delivery) Tracking and Reporting Misc. Quality Assurance and Business Systems Related Topics 13
A Outsourced Processes Control (Finished Medical Device Delivery, Storage) ISO 13485:2016 - Medical Device Quality Management Systems 10
M Partial Incoming (Receiving) Inspection Delivery Inspection. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
M Calculating Capability of Delivery Performance Capability, Accuracy and Stability - Processes, Machines, etc. 5
E Clinical Evaluation Report for a Delivery System ISO 13485:2016 - Medical Device Quality Management Systems 2
R Service Delivery Quality Tracker Document Control Systems, Procedures, Forms and Templates 2
S ANOVA and Test Method Validation for a Drug Delivery Device Statistical Analysis Tools, Techniques and SPC 4
B Is there a necessity of two sets of KPIs for Delivery Process Quality Manager and Management Related Issues 15
K ISO 9001 vs AS9100 Gap Analysis on Delivery Performance and Document Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
K AS9100 Post Delivery Support Template AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
B Corrective Action for Deviation (delay) in the Delivery Schedule Quality Manager and Management Related Issues 10
armani 2 Aspects of Services Design - Design of the Service and Design of Service Delivery Service Industry Specific Topics 2
S How do you Calculate On Time Delivery? Misc. Quality Assurance and Business Systems Related Topics 17
J Relationship between Quality, Reliability, Price and Delivery Misc. Quality Assurance and Business Systems Related Topics 7
M Understanding AS9100 Clause 7.5.1.4 Post-Delivery Support Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T CAR (Corrective Action Request) for On Time Delivery Nonconformance and Corrective Action 9
S Delivery Process Owner(s) in an IT Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Delivery Routing VRP (Vehicle Routing Problem) Problem Service Industry Specific Topics 2
D Route Delivery Efficiency Formula - Miles driven, number of deliveries, and time(hrs) Benchmarking 3
M Supplier Rating Form with Quality, Cost, Delivery wanted Document Control Systems, Procedures, Forms and Templates 4
D "On Time Delivery" Flowdown from Large Corporation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Q AS9100B Clause 7.5.1.5 - Where did it go in AS9100C? Servicing/Post Delivery Support AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Delivery Terminology - When is a product considered "Delivered" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
S On Time Delivery - Non conformance? Root Causes, Corrective Actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
E Use of MS Excel for Customer Delivery Tracking Statistical Analysis Tools, Techniques and SPC 6
L Lateness Delivery Notice to Customer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7

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