This document discusses regulatory aspects of drug-device combination products and provides examples of violations found in an FDA warning letter. It defines combination products and explains how the FDA determines the primary mode of action to assign the product to the appropriate FDA center for review. The warning letter outlines violations found at a manufacturer including failures to adequately investigate complaints, establish design controls and validation procedures, and perform required analyses of nonconformities and processes. Overall the document provides an overview of combination product regulation and examples of good manufacturing practice failures identified in an FDA inspection.
Transferring of details related to formulation and analytical strategies from one area to another area i.e. from R&D to production department and transferring of resulting product from lab scale to production scale. It’s a organized procedure including documented information and knowledge gained throughout the development. In pharmaceutical industry technology transfer includes steps from drug discovery to product development, clinical trials and full scale commercialization. According to WHO it’s a logical procedure that controls the transfer of any method along with its documentation and professional expertise between development and manufacturer.
The purpose of this presentation is to describe step by step the transition of a SAS Programmer into a Clinical Statistical Programmer. It can be used as guidelines for SAS Programmers who wants to put their programming and technical expertise into industries.
A SAS Programmer is someone who uses SAS software for different scenarios. The person who uses it for different purposes is known as a SAS Programmer.
On the other hand, a Clinical Statistical Programmer performs all the procedures to generate future outputs and makes advanced and real-world developments to face further challenges. A primary role of Clinical Statistical Programmers is to use their technical and programming skills in order to enable clinical trial statisticians to perform their statistical analysis duties more efficiently.
This presentation will briefly discuss about the smooth transition that a SAS Programmer needs to go through in order to become a Clinical Statistical Programmer.
This document outlines career paths in the pharmacovigilance industry for five roles: case processors, medical writers, medical reviewers, quality team, and IT support. For each role, it describes typical entry-level positions, opportunities for advancement to mid-level and senior positions such as team leads and managers, and ultimately senior management roles overseeing large portions of the pharmacovigilance process. Educational backgrounds required for each role are also listed.
This document discusses regulatory aspects of drug-device combination products and provides examples of violations found in an FDA warning letter. It defines combination products and explains how the FDA determines the primary mode of action to assign the product to the appropriate FDA center for review. The warning letter outlines violations found at a manufacturer including failures to adequately investigate complaints, establish design controls and validation procedures, and perform required analyses of nonconformities and processes. Overall the document provides an overview of combination product regulation and examples of good manufacturing practice failures identified in an FDA inspection.
Transferring of details related to formulation and analytical strategies from one area to another area i.e. from R&D to production department and transferring of resulting product from lab scale to production scale. It’s a organized procedure including documented information and knowledge gained throughout the development. In pharmaceutical industry technology transfer includes steps from drug discovery to product development, clinical trials and full scale commercialization. According to WHO it’s a logical procedure that controls the transfer of any method along with its documentation and professional expertise between development and manufacturer.
The purpose of this presentation is to describe step by step the transition of a SAS Programmer into a Clinical Statistical Programmer. It can be used as guidelines for SAS Programmers who wants to put their programming and technical expertise into industries.
A SAS Programmer is someone who uses SAS software for different scenarios. The person who uses it for different purposes is known as a SAS Programmer.
On the other hand, a Clinical Statistical Programmer performs all the procedures to generate future outputs and makes advanced and real-world developments to face further challenges. A primary role of Clinical Statistical Programmers is to use their technical and programming skills in order to enable clinical trial statisticians to perform their statistical analysis duties more efficiently.
This presentation will briefly discuss about the smooth transition that a SAS Programmer needs to go through in order to become a Clinical Statistical Programmer.
This document outlines career paths in the pharmacovigilance industry for five roles: case processors, medical writers, medical reviewers, quality team, and IT support. For each role, it describes typical entry-level positions, opportunities for advancement to mid-level and senior positions such as team leads and managers, and ultimately senior management roles overseeing large portions of the pharmacovigilance process. Educational backgrounds required for each role are also listed.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
FDA Regulations and Medical Device Pathways to Market | Kevin Daly | Lunch & ...UCICove
The document discusses FDA regulations for medical devices. It defines a medical device and outlines the steps to determine regulatory requirements, including classifying a device and identifying premarket pathways like 510(k) or PMA. Class I devices have the least requirements while Class III devices require the most oversight like clinical trials. The document reviews elements of 510(k) submissions and other clearance options like de novo. It also discusses quality system requirements and regulations for mobile medical apps and clinical studies.
Best practices for maintaining and storing essential documents in clinical re...TrialJoin
The complexity of a clinical research trial involves keeping and storing multiple essential documents that are necessary for a successful trial and quality results. The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity.
12 Steps for Medical Device UDI Submissions to the FDA GUDIDJoe Hage
UDI regulations kick in for Implantables and Class II devices in 2015.
Reed Tech subject matter expert Gary Saner is my go-to on this subject. He covered:
• Requirements of a GUDID submission system
• Process steps in selecting/launching a GUDID system and making submissions
• Data Fields – including those that are problematic
• Data Cleaning, Harmonization, and Validation tips
• Update on FDA’s changing GUDID guidance, e.g., convenience kits and implants
• Notes in setting up a FDA GUDID account
RELEVANT FOR:
• UDI Team Leaders/Members
• Regulatory Directors/Managers/Staff
• Manufacturing, Operations, and Supply Chain Logistics Personnel
• UDI IT Support Personnel
• Compliance Officers
• Distributors with UDI Submission Responsibilities
Video at http://medgroup.biz/UDI-in-2015
The document discusses the process for qualifying visual inspectors for pharmaceutical inspection including selecting inspectors based on vision and observation skills, extensive training using mock defect containers, and qualification testing to accurately identify defect types with acceptable error rates. It also reviews inspection parameters, defect categorization, sampling plans, and analytical techniques for investigating particulate matter found during inspection.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
FDA Regulations and Medical Device Pathways to Market | Kevin Daly | Lunch & ...UCICove
The document discusses FDA regulations for medical devices. It defines a medical device and outlines the steps to determine regulatory requirements, including classifying a device and identifying premarket pathways like 510(k) or PMA. Class I devices have the least requirements while Class III devices require the most oversight like clinical trials. The document reviews elements of 510(k) submissions and other clearance options like de novo. It also discusses quality system requirements and regulations for mobile medical apps and clinical studies.
Best practices for maintaining and storing essential documents in clinical re...TrialJoin
The complexity of a clinical research trial involves keeping and storing multiple essential documents that are necessary for a successful trial and quality results. The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity.
12 Steps for Medical Device UDI Submissions to the FDA GUDIDJoe Hage
UDI regulations kick in for Implantables and Class II devices in 2015.
Reed Tech subject matter expert Gary Saner is my go-to on this subject. He covered:
• Requirements of a GUDID submission system
• Process steps in selecting/launching a GUDID system and making submissions
• Data Fields – including those that are problematic
• Data Cleaning, Harmonization, and Validation tips
• Update on FDA’s changing GUDID guidance, e.g., convenience kits and implants
• Notes in setting up a FDA GUDID account
RELEVANT FOR:
• UDI Team Leaders/Members
• Regulatory Directors/Managers/Staff
• Manufacturing, Operations, and Supply Chain Logistics Personnel
• UDI IT Support Personnel
• Compliance Officers
• Distributors with UDI Submission Responsibilities
Video at http://medgroup.biz/UDI-in-2015
The document discusses the process for qualifying visual inspectors for pharmaceutical inspection including selecting inspectors based on vision and observation skills, extensive training using mock defect containers, and qualification testing to accurately identify defect types with acceptable error rates. It also reviews inspection parameters, defect categorization, sampling plans, and analytical techniques for investigating particulate matter found during inspection.
61. 61
為何氣流是食品衛生重要的一環?
氣流主要牽涉到空氣中的微生物 ( 及病原 ) 與灰塵。
美國 FDA 認為,廠區外的空氣,是造成部份食品中毒的原因。
這裡提到的微生物,包括造成腐敗以及造成疾病。
若是病原,則包括細菌、真菌、病毒
-->Heating Ventilation and Air Conditioning Systems
參考資料:
Using Sanitary Design to Avoid HACCP Hazards and Allergen Contamination
https://www.foodsafetymagazine.com/magazine-archive1/junejuly-2004/using-sanitary-design-to-avoid-haccp-
hazards-and-allergen-contamination/
3. 氣流
78. 78
對空氣中微生物 ( 細菌與黴菌 ) 在食品作業區的情況,有興趣的朋友
可以參考下方資料 ( 未依論文格式 )
Detection of airborne psychrotrophic bacteria and fungi in food storage refrigerators 2012, 開放式期刊
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3769052/
Assessment of airborne bacteria and fungi in food courts 2011
https://www.sciencedirect.com/science/article/abs/pii/S0360132311001235
Bioaerosols in the Food and Beverage Industry 2017
https://www.intechopen.com/books/ideas-and-applications-toward-sample-preparation-for-food-and-beverage-analysis/
bioaerosols-in-the-food-and-beverage-industry
Association of fungal genera from spoiled processed foods with physicochemical food properties
and processing conditions 2019
https://www.sciencedirect.com/science/article/pii/S0740002018308244
Airborne bacteria and mold in slaughterhouse facilities
https://www.moldbacteria.com/bacteria/airborne-bacteria-and-mold-in-slaughterhouse-facilities.html
WHO GUIDELINES FOR INDOOR AIR QUALITY
https://apps.who.int/iris/bitstream/handle/10665/164348/E92645.pdf?sequence=1&isAllowed=y
99. 99
氣簾 (air curtain) :減少外界 ( 髒 ) 空氣進入廠區,減少飛行類病媒進入
How an Air Curtain Works
https://www.youtube.com/watch?v=BprPV9hWR7k
圖片取自 AIR CURTAINS GUIDE BOOK, March 2016 ( 歐盟的氣簾指引手冊 )
他們主要目的是建築暖氣不外流的節能目的
https://eurovent.eu/sites/default/files/media/Eurovent%20-%20Air%20Curtains%20Guidebook%20-%20First
%20Edition.pdf
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