J&J Seminar Feb 21 08
•Download as PPT, PDF•
0 likes•299 views
The document outlines the agenda for a temperature control seminar hosted by Expeditors. The morning session will include introductions, an overview of Expeditors and their temperature control services, a discussion of common temperature ranges and trends in temperature control strategies, and case studies of US exports and imports requiring temperature control. The afternoon will include a facility tour, discussions of compliance and risk management, and developments in Expeditors' temperature control offerings.
Report
Share
Report
Share
![Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
Recommended
KEEP YOUR COOL- SHARING OF BEST PRACTICES
This document discusses best practices for maintaining the integrity of perishable drug products throughout the supply chain. It outlines Jamjoom Pharmaceutical's goals of ensuring drug safety, identity, strength, quality and purity. It then details Jamjoom's warehouse infrastructure and temperature control monitoring, as well as practices for inbound and outbound shipments, materials storage, and quality management. Challenges are also discussed, along with efforts through the Saudi Pharma Group to improve accountability across air transport.
Cold chain conference nov 7 2013 chicago
This document discusses vulnerabilities in cold chains that transport temperature-sensitive products like food. It begins by outlining various types of refrigerated facilities and vehicles used in cold chains. It then emphasizes the importance of establishing clear cold chain protocols, standards, and continuous temperature monitoring. Examples are provided showing how average temperatures over time impact product quality. The document suggests evaluating fleet operations and rationalizing asset sizes once cold chain standards are established. Overall it promotes a scientific, data-driven approach to cold chain management to improve food safety, quality control and supply chain efficiency.
An introduction to EECO2-Energy Efficiency Consultancy Limited
EECO2 is an energy efficiency consultancy that offers services to reduce HVAC energy costs in the pharmaceutical and life sciences industries. They have over 100 combined years of experience in design, construction, and operation of technical facilities. Their approach involves identifying opportunities to reduce air changes and optimize HVAC systems through workshops with clients. Case studies show they have helped clients in multiple countries reduce energy costs by 10-45% while maintaining product quality standards.
Hvac part 3
This document discusses commissioning, qualification, and maintenance of HVAC systems. It covers:
- Commissioning includes setting up, balancing, adjusting and testing the HVAC system to ensure it meets requirements, and training personnel. Records of installation, design measurements, manuals and reports are maintained.
- Qualification validates the HVAC system meets design specifications. It includes design qualification, installation qualification, operational qualification, and performance qualification based on a risk analysis. Critical parameters and components are tested.
- Maintenance includes inspection of documentation, operating and maintenance procedures, environmental records, and discussion of out of specification actions. Filters are changed and devices calibrated by trained personnel to ensure product quality and continued qualification.
Heating Ventilation and Air Conditioner HVAC Qualification
HVAC System (Heating Ventilation and Air Conditioner)
Qualification, Maintenance, Inspection, Clean room record, Qualification documentation, Conclusion
Scout Mobile WMS From DCT Mobile Solutions
Short Presentation of Scout Mobility Suite WMS (Warehouse Management System) from DCT Mobile Solutions
Workshop On Risk Assesment by Palash Ch Das
Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. Although there are some examples of the use of quality risk management in the pharmaceutical industry today, they are limited and do not represent the full contributions that risk management has to offer. In addition, the importance of quality systems has been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system.
Recommended
KEEP YOUR COOL- SHARING OF BEST PRACTICES
This document discusses best practices for maintaining the integrity of perishable drug products throughout the supply chain. It outlines Jamjoom Pharmaceutical's goals of ensuring drug safety, identity, strength, quality and purity. It then details Jamjoom's warehouse infrastructure and temperature control monitoring, as well as practices for inbound and outbound shipments, materials storage, and quality management. Challenges are also discussed, along with efforts through the Saudi Pharma Group to improve accountability across air transport.
Cold chain conference nov 7 2013 chicago
This document discusses vulnerabilities in cold chains that transport temperature-sensitive products like food. It begins by outlining various types of refrigerated facilities and vehicles used in cold chains. It then emphasizes the importance of establishing clear cold chain protocols, standards, and continuous temperature monitoring. Examples are provided showing how average temperatures over time impact product quality. The document suggests evaluating fleet operations and rationalizing asset sizes once cold chain standards are established. Overall it promotes a scientific, data-driven approach to cold chain management to improve food safety, quality control and supply chain efficiency.
An introduction to EECO2-Energy Efficiency Consultancy Limited
EECO2 is an energy efficiency consultancy that offers services to reduce HVAC energy costs in the pharmaceutical and life sciences industries. They have over 100 combined years of experience in design, construction, and operation of technical facilities. Their approach involves identifying opportunities to reduce air changes and optimize HVAC systems through workshops with clients. Case studies show they have helped clients in multiple countries reduce energy costs by 10-45% while maintaining product quality standards.
Hvac part 3
This document discusses commissioning, qualification, and maintenance of HVAC systems. It covers:
- Commissioning includes setting up, balancing, adjusting and testing the HVAC system to ensure it meets requirements, and training personnel. Records of installation, design measurements, manuals and reports are maintained.
- Qualification validates the HVAC system meets design specifications. It includes design qualification, installation qualification, operational qualification, and performance qualification based on a risk analysis. Critical parameters and components are tested.
- Maintenance includes inspection of documentation, operating and maintenance procedures, environmental records, and discussion of out of specification actions. Filters are changed and devices calibrated by trained personnel to ensure product quality and continued qualification.
Heating Ventilation and Air Conditioner HVAC Qualification
HVAC System (Heating Ventilation and Air Conditioner)
Qualification, Maintenance, Inspection, Clean room record, Qualification documentation, Conclusion
Scout Mobile WMS From DCT Mobile Solutions
Short Presentation of Scout Mobility Suite WMS (Warehouse Management System) from DCT Mobile Solutions
Workshop On Risk Assesment by Palash Ch Das
Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. Although there are some examples of the use of quality risk management in the pharmaceutical industry today, they are limited and do not represent the full contributions that risk management has to offer. In addition, the importance of quality systems has been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system.
ECOFLO- Hazardous Waste Management Process
This document summarizes ECOFLO's waste profiling, laboratory testing, transportation, emergency response, manifesting, waste tracking, invoicing, and health and safety procedures for handling hazardous waste. Key points include that ECOFLO will provide compatibility testing of waste streams, transportation via their trucks or subcontractors, 24/7 emergency response within 2 hours, state-approved manifests, waste tracking via barcode system, and health and safety training including HAZWOPER for employees.
Tài liệu (Phần 3) | Hệ thống HVAC
Tài liệu (Phần 3) | Hệ thống HVAC Công ty cổ phần GMPc Việt Nam | Tư vấn GMP, HS GMP, CGMP ASEAN, EU GMP, WHO GMP
This document provides an overview of commissioning, qualification, and maintenance of HVAC systems used in manufacturing facilities. It discusses the importance of commissioning the HVAC system to ensure it meets requirements before qualification. Qualification involves extensive testing and validation of the HVAC system and critical parameters like temperature, pressure, and airflows. A schedule of routine and strategic tests is outlined to continuously monitor the HVAC system and demonstrate ongoing compliance. Proper maintenance procedures and records are also essential to ensure the HVAC system continues to support product quality.Auditing of hvac by parag
Auditing of critical parameter:- HVAC(heating, ventilation and air conditioning system) 2021; In these presentation includes the requirement of HVAC, Auditing of HVAC components, technical analysis of HVAC components, WHO-GMP audis of HVAC then
Rogert william statement on HVAC, working of HVAC systems and their components Core function of HVAC, Market trends and market analysis of HVAC, WHO guidelines on HVAC system.
Staying Ahead of the Audit Curve with Food Industry Process Audits
Process audits are a new approach to evaluating the effectiveness of your SQF System. They involve selecting a finished product lot and then auditing all the specific SQF components related to that lot. With SQFI considering adopting this methodology in SQF Code Edition 8, now is the time to learn about this process and start conducting your own internal process audits. Join this session to learn more about this process to test your system now and be ready for what’s coming soon!
HVAC & Water in Pharmaceutical Manufacturing; From Theory to Application
This document discusses HVAC and water systems in pharmaceutical manufacturing from a regulatory perspective. It covers GMP manufacturing environments and controlling contamination sources. HVAC systems must effectively control airborne contaminants through ventilation and filtration. Water systems must provide clean water for use in cleaning and as an excipient. Proper documentation of HVAC and water systems is critical to ensure compliance with GMP regulations. Failures of HVAC components or water quality issues can lead to contamination and product recalls.
Optimizing Packaging for Temperature-Sensitive Shipments
Using the Risk-Controlled Ambient Thermal Profile (RCATP) Methodology for Improving Tertiary Package Design
CAC Meeting 18 September 2013
CAC Meeting 18 September 2013Program Executive Office, Assembled Chemical Weapons Alternatives (PEO ACWA)
Operational Readiness Review (ORR) The Road to Initial Agent Operations
Presented by:
Paul Dent, PCAPP ORR Manager
Thiết bị | Tài liệu GMP
Thiết bị | Tài liệu GMPCông ty cổ phần GMPc Việt Nam | Tư vấn GMP, HS GMP, CGMP ASEAN, EU GMP, WHO GMP
Tài liệu GMP được chia sẻ bởi GMPc Việt Nam - Nhà tư vấn Sáng tạo, Chuyên nghiệp, Toàn diện Dự án Nhà máy GMP (EU, PIC/S, WHO, ASEAN), ISO 13485:2012, ISO/IEC 17025:2005, ISO 15189:2012, ISO 15378:2011, ISO 9001:2008Design of warehouse
This document provides an overview of warehouse design for pharmaceutical products. It discusses key considerations for warehouse site selection and layout design, including maximizing space utilization and minimizing movement. It also covers types of material flows, storage systems, temperature controlled areas, packaging materials storage, sampling/dispensing booths, and automation technologies. The goal is to ensure efficient operations that maintain product quality and safety.
Servizi di mappatura per magazzini
Global regulatory agencies are pushing for comprehensive cold chain monitoring programs that extend from raw materials to distribution to patients. Proper validation and qualification of storage facilities has become necessary to demonstrate compliance with good manufacturing practices. Sensitech provides a variety of validation services including installation, operational, and performance qualification to ensure storage environments consistently meet acceptance criteria and protect product quality throughout the supply chain.
C A R N A V A L
El documento describe las actividades de un carnaval en San Fernando en 2008, incluyendo a los niños y sus madres disfrazados de príncipes, princesas y ninjas luchando contra monstruos, con la música de una charanga y la diversión continuando para todos.
MULTIMEDIA
El documento describe diferentes tipos de dispositivos de almacenamiento en una computadora, incluyendo la memoria RAM que almacena datos e instrucciones temporalmente, la memoria ROM que almacena el programa básico de inicio, el disco duro que almacena archivos de forma permanente, los disquetes flexibles que permiten almacenar y transportar datos, los discos ópticos como los CD-R que pueden almacenar 650MB de datos de solo lectura, y las memorias USB que se han vuelto populares para el almacenamiento y transporte personal de datos.
Applied Math 40S February 15, 2008
The document summarizes statistics on winning and losing streaks for the Manitoba Moose hockey team. It states that when the Moose win, there is a 70% chance they will win their next game, and when they lose there is a 40% chance they will win their next game. Some questions are asked about predicting the Moose's record over a 10 game stretch or 80 game regular season based on these probabilities.
PresentjjkiacióN2
A lo largo de los años, la autora ha experimentado varios cambios tanto físicos como emocionales. De ser una niña pequeña, curiosa e inocente, ahora es una mujer adulta con mayores responsabilidades y perspectivas sobre la vida. A pesar del paso del tiempo, sigue conservando parte de su espíritu infantil.
The Party!!!
The article discusses a soiree, or evening social gathering, that was held recently. Many guests attended the event and enjoyed appetizers, drinks, and conversation together. The soiree was a pleasant way for friends and acquaintances to socialize on a weeknight evening.
Suficiente
El documento relata un encuentro en el aeropuerto entre una madre y su hija que se están despidiendo. La madre le dice a la hija "te deseo lo suficiente", refiriéndose a desearle una vida llena solo de las cosas suficientemente buenas para vivir y apreciar. Luego la madre explica a una observadora el significado de este deseo, enumerando varias oraciones que transmiten el deseo de tener solo lo necesario para valorar los pequeños momentos de la vida.
Cumbresycielode La Palma Jn
La isla de La Palma en las Islas Canarias tiene cielos limpios que la hacen ideal para observar las estrellas, como se evidencia por la presencia del Gran Telescopio de Canarias y otros telescopios en el Observatorio Internacional de Astrofísica del Roque de los Muchachos. La isla también contiene paisajes impresionantes que van desde sus cumbres hasta el cielo y ofrece vistas de objetos celestes como cúmulos globulares, nebulosas y galaxias como la Vía Láctea y Andrómed
More Related Content
What's hot
ECOFLO- Hazardous Waste Management Process
This document summarizes ECOFLO's waste profiling, laboratory testing, transportation, emergency response, manifesting, waste tracking, invoicing, and health and safety procedures for handling hazardous waste. Key points include that ECOFLO will provide compatibility testing of waste streams, transportation via their trucks or subcontractors, 24/7 emergency response within 2 hours, state-approved manifests, waste tracking via barcode system, and health and safety training including HAZWOPER for employees.
Tài liệu (Phần 3) | Hệ thống HVAC
Tài liệu (Phần 3) | Hệ thống HVAC Công ty cổ phần GMPc Việt Nam | Tư vấn GMP, HS GMP, CGMP ASEAN, EU GMP, WHO GMP
This document provides an overview of commissioning, qualification, and maintenance of HVAC systems used in manufacturing facilities. It discusses the importance of commissioning the HVAC system to ensure it meets requirements before qualification. Qualification involves extensive testing and validation of the HVAC system and critical parameters like temperature, pressure, and airflows. A schedule of routine and strategic tests is outlined to continuously monitor the HVAC system and demonstrate ongoing compliance. Proper maintenance procedures and records are also essential to ensure the HVAC system continues to support product quality.Auditing of hvac by parag
Auditing of critical parameter:- HVAC(heating, ventilation and air conditioning system) 2021; In these presentation includes the requirement of HVAC, Auditing of HVAC components, technical analysis of HVAC components, WHO-GMP audis of HVAC then
Rogert william statement on HVAC, working of HVAC systems and their components Core function of HVAC, Market trends and market analysis of HVAC, WHO guidelines on HVAC system.
Staying Ahead of the Audit Curve with Food Industry Process Audits
Process audits are a new approach to evaluating the effectiveness of your SQF System. They involve selecting a finished product lot and then auditing all the specific SQF components related to that lot. With SQFI considering adopting this methodology in SQF Code Edition 8, now is the time to learn about this process and start conducting your own internal process audits. Join this session to learn more about this process to test your system now and be ready for what’s coming soon!
HVAC & Water in Pharmaceutical Manufacturing; From Theory to Application
This document discusses HVAC and water systems in pharmaceutical manufacturing from a regulatory perspective. It covers GMP manufacturing environments and controlling contamination sources. HVAC systems must effectively control airborne contaminants through ventilation and filtration. Water systems must provide clean water for use in cleaning and as an excipient. Proper documentation of HVAC and water systems is critical to ensure compliance with GMP regulations. Failures of HVAC components or water quality issues can lead to contamination and product recalls.
Optimizing Packaging for Temperature-Sensitive Shipments
Using the Risk-Controlled Ambient Thermal Profile (RCATP) Methodology for Improving Tertiary Package Design
CAC Meeting 18 September 2013
CAC Meeting 18 September 2013Program Executive Office, Assembled Chemical Weapons Alternatives (PEO ACWA)
Operational Readiness Review (ORR) The Road to Initial Agent Operations
Presented by:
Paul Dent, PCAPP ORR Manager
Thiết bị | Tài liệu GMP
Thiết bị | Tài liệu GMPCông ty cổ phần GMPc Việt Nam | Tư vấn GMP, HS GMP, CGMP ASEAN, EU GMP, WHO GMP
Tài liệu GMP được chia sẻ bởi GMPc Việt Nam - Nhà tư vấn Sáng tạo, Chuyên nghiệp, Toàn diện Dự án Nhà máy GMP (EU, PIC/S, WHO, ASEAN), ISO 13485:2012, ISO/IEC 17025:2005, ISO 15189:2012, ISO 15378:2011, ISO 9001:2008Design of warehouse
This document provides an overview of warehouse design for pharmaceutical products. It discusses key considerations for warehouse site selection and layout design, including maximizing space utilization and minimizing movement. It also covers types of material flows, storage systems, temperature controlled areas, packaging materials storage, sampling/dispensing booths, and automation technologies. The goal is to ensure efficient operations that maintain product quality and safety.
Servizi di mappatura per magazzini
Global regulatory agencies are pushing for comprehensive cold chain monitoring programs that extend from raw materials to distribution to patients. Proper validation and qualification of storage facilities has become necessary to demonstrate compliance with good manufacturing practices. Sensitech provides a variety of validation services including installation, operational, and performance qualification to ensure storage environments consistently meet acceptance criteria and protect product quality throughout the supply chain.
What's hot (10)
Staying Ahead of the Audit Curve with Food Industry Process Audits
Staying Ahead of the Audit Curve with Food Industry Process Audits
HVAC & Water in Pharmaceutical Manufacturing; From Theory to Application
HVAC & Water in Pharmaceutical Manufacturing; From Theory to Application
Optimizing Packaging for Temperature-Sensitive Shipments
Optimizing Packaging for Temperature-Sensitive Shipments
Viewers also liked
C A R N A V A L
El documento describe las actividades de un carnaval en San Fernando en 2008, incluyendo a los niños y sus madres disfrazados de príncipes, princesas y ninjas luchando contra monstruos, con la música de una charanga y la diversión continuando para todos.
MULTIMEDIA
El documento describe diferentes tipos de dispositivos de almacenamiento en una computadora, incluyendo la memoria RAM que almacena datos e instrucciones temporalmente, la memoria ROM que almacena el programa básico de inicio, el disco duro que almacena archivos de forma permanente, los disquetes flexibles que permiten almacenar y transportar datos, los discos ópticos como los CD-R que pueden almacenar 650MB de datos de solo lectura, y las memorias USB que se han vuelto populares para el almacenamiento y transporte personal de datos.
Applied Math 40S February 15, 2008
The document summarizes statistics on winning and losing streaks for the Manitoba Moose hockey team. It states that when the Moose win, there is a 70% chance they will win their next game, and when they lose there is a 40% chance they will win their next game. Some questions are asked about predicting the Moose's record over a 10 game stretch or 80 game regular season based on these probabilities.
PresentjjkiacióN2
A lo largo de los años, la autora ha experimentado varios cambios tanto físicos como emocionales. De ser una niña pequeña, curiosa e inocente, ahora es una mujer adulta con mayores responsabilidades y perspectivas sobre la vida. A pesar del paso del tiempo, sigue conservando parte de su espíritu infantil.
The Party!!!
The article discusses a soiree, or evening social gathering, that was held recently. Many guests attended the event and enjoyed appetizers, drinks, and conversation together. The soiree was a pleasant way for friends and acquaintances to socialize on a weeknight evening.
Suficiente
El documento relata un encuentro en el aeropuerto entre una madre y su hija que se están despidiendo. La madre le dice a la hija "te deseo lo suficiente", refiriéndose a desearle una vida llena solo de las cosas suficientemente buenas para vivir y apreciar. Luego la madre explica a una observadora el significado de este deseo, enumerando varias oraciones que transmiten el deseo de tener solo lo necesario para valorar los pequeños momentos de la vida.
Cumbresycielode La Palma Jn
La isla de La Palma en las Islas Canarias tiene cielos limpios que la hacen ideal para observar las estrellas, como se evidencia por la presencia del Gran Telescopio de Canarias y otros telescopios en el Observatorio Internacional de Astrofísica del Roque de los Muchachos. La isla también contiene paisajes impresionantes que van desde sus cumbres hasta el cielo y ofrece vistas de objetos celestes como cúmulos globulares, nebulosas y galaxias como la Vía Láctea y Andrómed
Web Searching
Los buscadores no pueden indexar toda la web debido a su enorme tamaño y complejidad. Factores como los altos costes, las limitaciones técnicas, el spam y las restricciones de acceso dificultan que los buscadores cubran todo el contenido. Los buscadores usan arañas para encontrar periódicamente nuevos sitios y actualizaciones, indexan y almacenan la información encontrada en bases de datos, y usan motores de búsqueda y algoritmos para procesar las consultas y mostrar los resultados.
Web Searching
Los buscadores no pueden indexar toda la web debido a su enorme tamaño y complejidad. Factores como los altos costes, las limitaciones técnicas, el spam y las restricciones de acceso dificultan que los buscadores cubran todo el contenido. Los buscadores usan arañas para encontrar periódicamente nuevos sitios y actualizaciones, indexan y almacenan la información encontrada en bases de datos, y usan motores de búsqueda y algoritmos para procesar las consultas y mostrar los resultados.
Perseverancia
Este documento habla sobre la lección de perseverancia que podemos aprender de los pájaros. A pesar de que sus nidos son destruidos repetidamente por las inclemencias del tiempo o depredadores, los pájaros no se rinden y siguen reconstruyéndolos una y otra vez hasta que logran criar con éxito sus polluelos. Del mismo modo, cuando nos golpea la vida no debemos rendirnos, sino continuar luchando y reconstruyendo lo que se ha perdido hasta alcanzar nuestras metas, sin importar cuántas veces
2008 Clay Works
This document lists the names of 15 students from the 2008 Clay Works created by the Visual Arts Education 10/20/30 students at Robert Usher Collegiate. The document credits each student with their work from 2008 and notes that the clay works were created as part of their visual arts education course.
El Che Y La Revolucion
El documento hace un llamado a la revolución para iniciar una nueva era de democracia y paz, sugiriendo que el sistema actual falla y daña al pueblo. Insta a las personas a pensar por sí mismas, rebelarse contra el sistema e unirse al levantamiento, viendo a Ernesto "Che" Guevara como una figura mesiánica.
Cef^SL 08 Apresentacao 2 (2008-02-14)
Este documento descreve o programa e organização da conferência CEF_SL 08 sobre comunicação, educação e formação no ambiente virtual Second Life. A conferência ocorrerá entre 26 e 28 de junho e incluirá sessões, palestrantes convidados, e workshops sobre diversos tópicos relacionados ao Second Life.
Viewers also liked (20)
Similar to J&J Seminar Feb 21 08
How to Validate Temperatures Within the Supply Chain
This document discusses how to validate temperatures within the supply chain for pharmaceuticals. It covers standards and regulations, the validation process including developing a protocol, packaging design and testing. Specific topics covered include trailer validation variables, Health Canada Guide 0069 requirements, ISTA testing standards, and how to design packaging and conduct validation testing. The goal is to document that temperatures are controlled throughout the logistics process.
Holistic management of risk in temperature controlled shipments – an operatio...
Identify and implement proper risk management to ensure both shelf life and quality of products. Developing the right storage conditions and packaging infrastructure in your cold chain.
7 lý do tại sao giám sát chuỗi cung ứng lạnh là một vấn đề lớn
7 lý do tại sao giám sát chuỗi cung ứng lạnh là một vấn đề lớnCông ty Cổ phần Tư vấn Thiết kế GMP EU
Các sản phẩm nhạy cảm với nhiệt độ như hóa chất, thịt, thực vật, thuốc và vắc-xin yêu cầu phải kiểm soát nhiệt độ từ khâu sản xuất đến tiêu dùng và mọi bước trung gian.
Tính nhất quán về nhiệt độ đảm bảo chất lượng của các sản phẩm này khi chúng di chuyển qua các chuỗi cung ứng tương ứng. Tuy nhiên, đảm bảo tính nhất quán nhiệt độ là một thách thức.
Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn thiết kế GMP EU.5 Keys to Successful Warehouse and ColdRoom Monitoring
Thực phẩm dễ hỏng ngay cả khi chúng được tối ưu hóa trong việc chế biến và đóng gói. Chúng cần được phân phối và lưu trữ một cách thích hợp để đảm bảo chất lượng và thời hạn sử dụng của chúng. Các mặt hàng dễ hỏng như sữa, rau, trái cây, hải sản, thịt, đồ đông lạnh và các sản phẩm dược phẩm như thuốc, vắc-xin, thuốc tiêm, v.v. Những sản phẩm này rất nhạy cảm với nhiệt độ và hạn sử dụng của chúng bị ảnh hưởng nếu không được bảo quản phù hợp. Để đảm bảo điều đó, cần có các kho chuỗi lạnh hiệu quả - nơi có thể quản lý sản phẩm, đồng thời giảm hao hụt.
Cold Chain May 2015
This document discusses the importance of maintaining proper cold chain management for pharmaceutical products, especially clinical trial materials. It covers definitions of active and passive cold chain systems, requirements for validation of cold chain processes, challenges in global clinical trials, and the roles of service providers and regulations. Proper cold chain is crucial for ensuring product quality and safety.
Infitrak Corporate Overview Presentation
As a leader in providing of cold chain compliance services, packaging and intelligent monitoring solutions, we hope that you will find everything you need to assure your product remains in compliance with regulatory guidelines, and is stored or transported under ideal conditions.
Hướng dẫn bảo quản và vận chuyển dược phẩm nhạy cảm với nhiệt độ
Hướng dẫn bảo quản và vận chuyển dược phẩm nhạy cảm với nhiệt độCông ty cổ phần GMPc Việt Nam | Tư vấn GMP, HS GMP, CGMP ASEAN, EU GMP, WHO GMP
This document provides guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (TTSPPs). It covers topics such as port handling and customs clearance, warehouse site selection and layout, storage building requirements, temperature control, transport qualifications, and quality management procedures. The guidance is intended to help minimize risks to these sensitive products from factors like theft, temperature excursions, and delays in the supply chain.Phụ lục 9. Hướng dẫn bảo quản, vận chuyển các sản phẩm nhạy cảm về nhiệt độ, ...
Phụ lục 9. Hướng dẫn bảo quản, vận chuyển các sản phẩm nhạy cảm về nhiệt độ, ...Công ty Cổ phần Tư vấn Thiết kế GMP EU
This document provides guidance for the storage and transport of pharmaceutical products that require temperature control. It outlines requirements for port handling, customs clearance, warehouse site selection and layout, storage building construction, temperature control during storage and transport, calibration of monitoring devices, transport qualifications, and quality management procedures. The goal is to minimize risks to these temperature-sensitive drugs from factors like theft, temperature excursions, improper storage or transport conditions.Cold Storage Warehouse Best Practices: Forecasting & End-to-End Temperature M...
As products evolve and consumer demands change cold storage warehouse space is a more critical branch of the supply chain than ever. Products being stored in these refrigerated warehouses include frozen and refrigerated food, pharmaceuticals, petro-chemicals and high-tech electronics. Many of these products are strictly regulated by government agencies such as the FDA. To maintain compliant with these regulations many cold storage operations are focusing on implementing industry best practices. A top priority has continued to be temperature forecasting and monitoring and technology upgrades.
Forecasting temperature demand helps businesses operating in the cold chain to accommodate to changes in product demand and the financial implications. Completing inventory forecasts often will help to give your business a clear understanding of storage space requirements and what changes can be made the make the most of your existing facility space.
One way cold storage warehouses are making the most of their space is by implementing temporary curtains that allow them to break up facility space in order to create, expand or reduce the square footage of temperature zones. The flexibility of this tool helps refrigerated warehouse operators to reduce energy consumption while also ensuring temperature consistency to avoid spoiling.
In an effort to avoid the average 6 recalls that occur in the U.S. each day cold storage warehouses are implementing new and cutting edge technologies to aid in the tracking and monitoring of inventory temperature and condition. These tools include: thermometers for manual QA readings on an inventory or temperature zone level, RFID tags for passive temperature monitoring and location identification, data loggers for in-transit deliveries direct-to-customer, smart shipping containers for LTL and FTL shipments, and WMS for a centralized data collection and storage database. All of these tools used in varying combinations can help cold storage warehouses to reduce costs, improve data accuracy, guarantee product quality and maintain regulatory compliance.
Evaluate how these technologies can help your refrigerated warehouse implement industry best practices in temperature monitoring and tracking and solve any pre-existing QA issues today. Contact Datex experts with questions or for more information on this topic at marketing@datexcorp.com or 800.933.2839 ext 243.
P tech 100 session 2 fall 2012
The document provides an overview of process technology and the role of process technicians. It defines process technology as the processes and technologies required to transform raw materials into products. It describes the common operations within process industries and lists several key industries. It outlines the duties of process technicians, which include monitoring equipment, maintenance, troubleshooting, communication, and ensuring safety. It discusses the types of equipment used and working conditions, which can include all weather, outdoor work, shift work, and tool usage.
Autoclave Report Layout
This document discusses the qualification-validation procedure for moist heat sterilization processes. It involves qualifying the autoclave by checking its performance against design specifications, validating the sterilization process by establishing its effectiveness and reproducibility, and assessing potential changes to products during sterilization. The procedure consists of installation, operational, and performance qualification phases to collect evidence that the autoclave is properly installed, functions as intended, and can reliably sterilize products. Critical factors like temperature sensors and controls must be calibrated, and thermocouples placed strategically to monitor temperatures throughout sterilization cycles.
How to perform an efficient Cold Chain Compliance and Gap Analysis
The purpose of Gap Analysis is to assist pharmaceutical manufacturers, distributors or 3 PLs (3rd Party Logistics Providers) to help them identify gaps in their cold chain supply chain network or systems.
What you will learn:
* The regulatory aspects related to the cold chain
* Responsibilities in the supply chain
* Requirements for the storage and handling of drug products
* Packaging, transportation and distribution of drug products
* Performing a gap analysis to know what needs to be done in order to fully comply with regulations and optimize your processes
* Ways and means to develop an executable action plan
How you will benefit:
* Understand how to execute a cold chain regulatory gap analysis
* Discover what should be covered when looking at cold chain compliance
* Gap analysis: The first step to develop a cold chain compliance program
* Uncover the requirements for the storage and distribution of drug products
* Sharing the responsibilities for a good cold chain compliance
Specialty Solutions For Industry
FedEx provides specialty solutions for the healthcare industry, including temperature-controlled shipping and packaging options to safely transport medical samples and pharmaceuticals. They have over 11,000 healthcare customers in areas like biotech. FedEx also supports various healthcare non-profits through donations of shipping and aircraft. Their portfolio includes monitoring solutions, temperature-controlled vehicles and containers, and supply chain management services tailored for healthcare customers' needs.
Supply Chain & Logistics Basics: Maintaining End-to-End Cold Chain Integrity
Maintaining end-to-end cold chain integrity is a critical focus for all cold storage operations as much of their inventory is consumed directly by end customers. If any instance of impropriety throughout the supply chain occurs it could lead to widespread sickness or death. On average, 10% of all pharmaceutical inventory is temperature controlled and a significantly larger portion of food products are also temperature controlled. Any contamination could result in thousands or even millions of dollars in inventory loss, logistics costs and settlement fees. Preventing inventory contamination in the cold chain has increased in complexity as the supply chain has globalized. A larger portion of temperature regulated goods are crossing international borders creating both regulatory challenges as well more opportunities for failure and/or complication before goods reach their final destination. Some of the most notable regulations impacting the cold chain are the Sanitary Food Transportation Act, Food Safety Modernization Act (FSMA) and EU Good Distribution Practices. These pieces of legislation impact all key supply chain players including those that manufacture, store, transport and sell refrigerated and frozen products. Much of this legislation closely regulates the tracking and storage of handling and temperature related inventory data.
In an effort to solve cold chain challenges related to temperature maintenance, monitoring and recording supply chain operators handling temperature regulated inventory have begun to implement some successful industry best practices. Inventory pre-cooling has proven successful in reducing the wear and tear on refrigeration equipment and helps to guarantee temperature consistency from the time it is loaded until it is unloaded. Many cold chain businesses have also installed trailer condition monitoring systems that monitor temperature conditions in real time and send alerts if any unacceptable temperature variations are encountered. Packaging optimization has also proven useful in extending shelf life and improving product condition. In addition to monitoring trailer conditions, cold chain operators are also implementing inventory temperature monitoring technologies to track inventory status on a piece by piece or pallet by pallet basis. Retailers have also been encouraged to develop standard operating procedures (SOPs) for receiving to ensure only inventory of the highest quality ends up on their shelves and in consumer hands. With capacity increasing and the supply chain growing globally it is more critical than ever that the cold chain implement these best practices in order to keep consumers safe.
Qualification of HVAC Systems As Per WHO
Qualification of HVAC Systems As Per WHO
Documentation requirements to assist in commissioning, qualification and maintenance
Objectives
Commissioning
Qualification
Design conditions and normal operating ranges set to achievable limits
OOS results recorded
Qualification – examples of aspects to consider
Schedule of tests to demonstrate continuing compliance
Cleanroom monitoring program (1)
Cleanroom monitoring program (2) Particles and Microbiological contaminants
Definition of Conditions
examples of aspects to consider in qualification (OQ, PQ)
Maintenance
Inspecting the air handling system
Global Cold Chain Solutions - Services and Products
A brief on how GCCS products and services can help eliminate the risk of non compliance in Shipping Temperature sensitive products.
Global Cold Chain Solutions - Services and Products
GDP Compliant Cold Chain Packaging and services. Temperature Data loggers, Temperature controlled packaging, Shippers, Pallet Shippers
009 what are the systems validation protocol methods at atl 05 28-2015
If your product must meet the requirements of FDA cGMP, 21 CFR 210, 211, 820, ISO-9000, ISO-13485, or MDD/93/42/EEC (for the CE Mark), there are three very critical elements you must have to be in regulatory compliance. First, you must have a sound and strong Quality Management System (QMS). This is an expression of WHAT you do (your quality policies and structure). Second, you must have reliable Standard Operating Procedures (SOP’s). These are expressions of HOW YOU DO THINGS.
Missing in the above two items is an expression of HOW WELL YOU DO WHAT YOU DO? This is where you must establish your “Systems Validation Protocol” (SVP). Your SVP is an expression of how well your system is working (for example, this can be expressed in overall product conformance percentage or in defects per million for your various products). The SVP is a living and continuous document based on your quality records. The ATL White Paper “What Are The Systems Validation Protocol Methods At ATL?” is our attempt to share with you a sound approach to Systems Validation and the various protocols that you can use.
AEDFinalPresentation
This document discusses temperature controlled shipping, or cold chain, for pharmaceuticals. It introduces cold chain and explains that pharmaceuticals need to be maintained within a specific temperature range during shipment. It then discusses challenges in cold chain shipping, such as choosing the correct shipping system based on weather conditions. The document proposes a tool that would allow users to enter shipment dates and locations and utilize historical weather data to determine weather conditions and recommend appropriate shipping systems. It provides examples of how sales managers, pharmaceutical companies, and inventory managers would utilize features of the proposed tool.
Similar to J&J Seminar Feb 21 08 (20)
How to Validate Temperatures Within the Supply Chain
How to Validate Temperatures Within the Supply Chain
Holistic management of risk in temperature controlled shipments – an operatio...
Holistic management of risk in temperature controlled shipments – an operatio...
7 lý do tại sao giám sát chuỗi cung ứng lạnh là một vấn đề lớn
7 lý do tại sao giám sát chuỗi cung ứng lạnh là một vấn đề lớn
5 Keys to Successful Warehouse and ColdRoom Monitoring
5 Keys to Successful Warehouse and ColdRoom Monitoring
Hướng dẫn bảo quản và vận chuyển dược phẩm nhạy cảm với nhiệt độ
Hướng dẫn bảo quản và vận chuyển dược phẩm nhạy cảm với nhiệt độ
Phụ lục 9. Hướng dẫn bảo quản, vận chuyển các sản phẩm nhạy cảm về nhiệt độ, ...
Phụ lục 9. Hướng dẫn bảo quản, vận chuyển các sản phẩm nhạy cảm về nhiệt độ, ...
Cold Storage Warehouse Best Practices: Forecasting & End-to-End Temperature M...
Cold Storage Warehouse Best Practices: Forecasting & End-to-End Temperature M...
How to perform an efficient Cold Chain Compliance and Gap Analysis
How to perform an efficient Cold Chain Compliance and Gap Analysis
Supply Chain & Logistics Basics: Maintaining End-to-End Cold Chain Integrity
Supply Chain & Logistics Basics: Maintaining End-to-End Cold Chain Integrity
Global Cold Chain Solutions - Services and Products
Global Cold Chain Solutions - Services and Products
Global Cold Chain Solutions - Services and Products
Global Cold Chain Solutions - Services and Products
009 what are the systems validation protocol methods at atl 05 28-2015
009 what are the systems validation protocol methods at atl 05 28-2015
Recently uploaded
-- June 2024 is National Volunteer Month --
Check out our June display of books on voluntary organisations
Income Tax exemption for Start up : Section 80 IAC
A presentation on the concept of Exemption of Profits of Start ups from Income Tax
Best practices for project execution and delivery
A select set of project management best practices to keep your project on-track, on-cost and aligned to scope. Many firms have don't have the necessary skills, diligence, methods and oversight of their projects; this leads to slippage, higher costs and longer timeframes. Often firms have a history of projects that simply failed to move the needle. These best practices will help your firm avoid these pitfalls but they require fortitude to apply.
LA HUG - Video Testimonials with Chynna Morgan - June 2024
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
1. How to capture video testimonials that convert from your audience 🎥
2. How to leverage your testimonials to boost your sales 💲
3. How you can capture more CRM data to understand your audience better through video testimonials. 📊
Creative Web Design Company in Singapore
At Techbox Square, in Singapore, we're not just creative web designers and developers, we're the driving force behind your brand identity. Contact us today.
buy old yahoo accounts buy yahoo accounts
As a business owner, I understand the importance of having a strong online presence and leveraging various digital platforms to reach and engage with your target audience. One often overlooked yet highly valuable asset in this regard is the humble Yahoo account. While many may perceive Yahoo as a relic of the past, the truth is that these accounts still hold immense potential for businesses of all sizes.
Top mailing list providers in the USA.pptx
Discover the top mailing list providers in the USA, offering targeted lists, segmentation, and analytics to optimize your marketing campaigns and drive engagement.
Business storytelling: key ingredients to a story
Storytelling is an incredibly valuable tool to share data and information. To get the most impact from stories there are a number of key ingredients. These are based on science and human nature. Using these elements in a story you can deliver information impactfully, ensure action and drive change.
How MJ Global Leads the Packaging Industry.pdf
MJ Global's success in staying ahead of the curve in the packaging industry is a testament to its dedication to innovation, sustainability, and customer-centricity. By embracing technological advancements, leading in eco-friendly solutions, collaborating with industry leaders, and adapting to evolving consumer preferences, MJ Global continues to set new standards in the packaging sector.
Tata Group Dials Taiwan for Its Chipmaking Ambition in Gujarat’s Dholera
The Tata Group, a titan of Indian industry, is making waves with its advanced talks with Taiwanese chipmakers Powerchip Semiconductor Manufacturing Corporation (PSMC) and UMC Group. The goal? Establishing a cutting-edge semiconductor fabrication unit (fab) in Dholera, Gujarat. This isn’t just any project; it’s a potential game changer for India’s chipmaking aspirations and a boon for investors seeking promising residential projects in dholera sir.
Visit : https://www.avirahi.com/blog/tata-group-dials-taiwan-for-its-chipmaking-ambition-in-gujarats-dholera/
2024-6-01-IMPACTSilver-Corp-Presentation.pdf
IMPACT Silver is a pure silver zinc producer with over $260 million in revenue since 2008 and a large 100% owned 210km Mexico land package - 2024 catalysts includes new 14% grade zinc Plomosas mine and 20,000m of fully funded exploration drilling.
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
In the recent edition, The 10 Most Influential Leaders Guiding Corporate Evolution, 2024, The Silicon Leaders magazine gladly features Dejan Štancer, President of the Global Chamber of Business Leaders (GCBL), along with other leaders.
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Taste
Know what your zodiac sign says about your taste in food! Explore how the 12 zodiac signs influence your culinary preferences with insights from MyPandit. Dive into astrology and flavors!
Structural Design Process: Step-by-Step Guide for Buildings
The structural design process is explained: Follow our step-by-step guide to understand building design intricacies and ensure structural integrity. Learn how to build wonderful buildings with the help of our detailed information. Learn how to create structures with durability and reliability and also gain insights on ways of managing structures.
Call 8867766396 Satta Matka Dpboss Matka Guessing Satta batta Matka 420 Satta...
CALL 8867766396 SATTA MATKA | DPBOSS | KALYAN MAIN BAZAR | FAST MATKA | DPBOSS GUESSING | TARA MATKA | KALYAN CHART | MATKA BOSS
Recently uploaded (20)
Income Tax exemption for Start up : Section 80 IAC
Income Tax exemption for Start up : Section 80 IAC
LA HUG - Video Testimonials with Chynna Morgan - June 2024
LA HUG - Video Testimonials with Chynna Morgan - June 2024
Tata Group Dials Taiwan for Its Chipmaking Ambition in Gujarat’s Dholera
Tata Group Dials Taiwan for Its Chipmaking Ambition in Gujarat’s Dholera
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Taste
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Taste
Structural Design Process: Step-by-Step Guide for Buildings
Structural Design Process: Step-by-Step Guide for Buildings
Call 8867766396 Satta Matka Dpboss Matka Guessing Satta batta Matka 420 Satta...
Call 8867766396 Satta Matka Dpboss Matka Guessing Satta batta Matka 420 Satta...
J&J Seminar Feb 21 08
- 1. Introductions – Opening Remarks
- 5. Common Temperature Ranges Active Ingredients Biological agents Raw Materials Reagent Active Ingredient Bulk Dosage Finished Dosage Vaccines Insulin Reagent Solid Dosage Gel Caps Trans-dermal Patches Ointments/Lotions Ampules
- 14. Lunch