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хвороби суглобів
хвороби суглобів
хвороби суглобів
demon4ik demon4ik
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
FDA Focus on Design Controls
FDA Focus on Design Controls
April Bright
Clinical Trials for Medical Devices
Клинические Испытания Медицинских Изделий
Клинические Испытания Медицинских Изделий
Alexey Stepanov
Pneumocystis carinii
Pneumocystis carinii
Katsushige Takagishi
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use. In this webinar, you will learn: • Closed Processing and Single Use Technology implementation • Points to consider using Single Use Technology • Sterile Filtration The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...
MilliporeSigma
The U.S. FDA and international regulatory bodies require usability testing of medical devices, products, software, and systems as part of their overall validation. Manufacturers must demonstrate that all potential use-related hazards have been identified, prioritized, and mitigated. The method for demonstrating this is human factors/usability engineering (HF/UE) validation testing. However, the way we conduct these studies is in many ways different from the way we conduct studies of non-medical products and systems. This topic is relevant to the Boston UX community given the convergence of consumer and medical devices, as well as the rise of wearable technologies and the apps that interact with them. This presentation will cover the key aspects of HF/UE validation (a.k.a. ‘summative’) testing and what the FDA expects in the final HF/UE summary report. Importantly, this session will consist of half presentation and half Q&A, with the audience driving the discussion toward current issues, questions, and challenges that are relevant to them.
Usability Validation Testing of Medical Devices and Software
Usability Validation Testing of Medical Devices and Software
UXPA Boston
Access the interactive recording here: https://bit.ly/2mvFxs7 Abstract: The support for EMA GMPs related to sterile medicinal products is Annex 1. EMA, PICS and WHO have collaborated on the largest and most comprehensive revision of Annex 1 since it was first written in 1997. There are a number of proposed changes to the sections in Annex 1 dealing with filtration, integrity testing and single-use. This presentation will compare the current version with the proposed changes and highlight areas of specific interest to companies who either manufacture in or export to EMA countries, PICS member countries, and WHO compliant countries.
Potential Impact of Draft Annex 1 on Sterilizing Filtration
Potential Impact of Draft Annex 1 on Sterilizing Filtration
MilliporeSigma
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хвороби суглобів
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demon4ik demon4ik
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
FDA Focus on Design Controls
FDA Focus on Design Controls
April Bright
Clinical Trials for Medical Devices
Клинические Испытания Медицинских Изделий
Клинические Испытания Медицинских Изделий
Alexey Stepanov
Pneumocystis carinii
Pneumocystis carinii
Katsushige Takagishi
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use. In this webinar, you will learn: • Closed Processing and Single Use Technology implementation • Points to consider using Single Use Technology • Sterile Filtration The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...
MilliporeSigma
The U.S. FDA and international regulatory bodies require usability testing of medical devices, products, software, and systems as part of their overall validation. Manufacturers must demonstrate that all potential use-related hazards have been identified, prioritized, and mitigated. The method for demonstrating this is human factors/usability engineering (HF/UE) validation testing. However, the way we conduct these studies is in many ways different from the way we conduct studies of non-medical products and systems. This topic is relevant to the Boston UX community given the convergence of consumer and medical devices, as well as the rise of wearable technologies and the apps that interact with them. This presentation will cover the key aspects of HF/UE validation (a.k.a. ‘summative’) testing and what the FDA expects in the final HF/UE summary report. Importantly, this session will consist of half presentation and half Q&A, with the audience driving the discussion toward current issues, questions, and challenges that are relevant to them.
Usability Validation Testing of Medical Devices and Software
Usability Validation Testing of Medical Devices and Software
UXPA Boston
Access the interactive recording here: https://bit.ly/2mvFxs7 Abstract: The support for EMA GMPs related to sterile medicinal products is Annex 1. EMA, PICS and WHO have collaborated on the largest and most comprehensive revision of Annex 1 since it was first written in 1997. There are a number of proposed changes to the sections in Annex 1 dealing with filtration, integrity testing and single-use. This presentation will compare the current version with the proposed changes and highlight areas of specific interest to companies who either manufacture in or export to EMA countries, PICS member countries, and WHO compliant countries.
Potential Impact of Draft Annex 1 on Sterilizing Filtration
Potential Impact of Draft Annex 1 on Sterilizing Filtration
MilliporeSigma
Vortrag beim 14. Schnittstellenseminar "Umgang mit chronischen Wunden in der stationären Altenpflege" des Berliner Projekts am 26.11.2014 im Lazarus-Haus in Berlin.
Digitale Wunddokumentation und Wundfotografie
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Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification. In this webinar, you will learn to: • Focus on practical QbD terms and approaches • Highlight critical product quality aspects of sterile medicinal products • Develop design and control spaces for sterilizing filtration • Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production Abstract: Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
Quality by Design Principles Applied to Sterilizing Filtration by Michael Payne
Quality by Design Principles Applied to Sterilizing Filtration by Michael Payne
Merck Life Sciences
<NEURAL GP Networkとは> 島根県初・総合診療医育成プロジェクト 地域医療現場と大学を結ぶTeal型組織構造 診療医療の育成は現場においてのみ可能である。 しかし、現場だけでは日本全体の総合診療を成長させるには不十分。 だから、わたしたちは今、 島根県からITを駆使して総合医療のニューラルネットワーク構築を目指します。 NEURAL GP Network WEBサイト: https://shimanegp.com/
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Participate in the interactive webinar: http://bit.ly/SU-ADCWebinar Challenges of ADC manufacturing can be tackled by adopting single-use technology. Solutions will be presented about how to overcome concerns and implement a processing platform, supported through a strong vendor-manufacturer relationship. Explore our webinar library: www.merckmillipore.com/webinars
Using Single-use Technology to Overcome the Challenges of ADC Processing
Using Single-use Technology to Overcome the Challenges of ADC Processing
Merck Life Sciences
As single-use technologies continue to expand in pharmaceutical manufacturing processes, the risk assessment for extractables and leachables becomes increasingly complex. Join this webinar to obtain guidance on how to perform risk evaluation on a process with multiple single-use components. A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps-- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk. This webinar will evaluate the different single-use components with respect to compatibility and extractables and leachables. A case study will be used to demonstrate the complexity and potential concerns when performing a risk evaluation on the manufacturing process. In this webinar, you will learn: - Risk assessment of extractables - Single-use component evaluation - Complexity when evaluating multiple assemblies
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...
MilliporeSigma
<NEURAL GP Networkとは> 島根県初・総合診療医育成プロジェクト 地域医療現場と大学を結ぶTeal型組織構造 診療医療の育成は現場においてのみ可能である。 しかし、現場だけでは日本全体の総合診療を成長させるには不十分。 だから、わたしたちは今、 島根県からITを駆使して総合医療のニューラルネットワーク構築を目指します。 NEURAL GP Network WEBサイト: https://shimanegp.com/
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Watch the presentation of this webinar here: https://bit.ly/3tDy8Ei Recent PDA/BioPhorum publications outline risks for PUPSIT in sterilizing filtration. This webinar will summarize the key points and best practices for implementing PUPSIT. PDA and BioPhorum have partnered to form a task force whose goal was to provide the industry and regulators with scientific data and analysis on the potential risks and benefits of implementing PUPSIT to improve sterility assurance. This webinar will describe the data generated by the task force studies and discuss considerations and best practices when implementing PUPSIT. In this webinar, you will learn: • How changing industry perspectives help overcome regulatory concerns and may influence regulatory perspective • How improved process understanding affects risk assessment • How improved final fill assembly design simplifies PUPSIT
Does PUPSIT Reduce Risk for Sterile Filtration?
Does PUPSIT Reduce Risk for Sterile Filtration?
Merck Life Sciences
<NEURAL GP Networkとは> 島根県初・総合診療医育成プロジェクト 地域医療現場と大学を結ぶTeal型組織構造 診療医療の育成は現場においてのみ可能である。 しかし、現場だけでは日本全体の総合診療を成長させるには不十分。 だから、わたしたちは今、 島根県からITを駆使して総合医療のニューラルネットワーク構築を目指します。 NEURAL GP Network WEBサイト: https://shimanegp.com/
嘔気嘔吐 問診診断 パート2
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Why did the company not design and formulate a tablet that did not “cap”? Why wouldn’t NIH fund my proposal for CAFD? Why did the FDA [discount] Pharmaceutical Development Reports, while in the EU and Japan, is it an essential part of the regulatory review? Under a hypothetical social inspection scheme, a report submitted in 2010 is imagined as PM 483 in the spirit of FDA Form 483 of “Inspectional Observations.” What do the noted observations suggest about my professional maturity or state of mind at that event in 2010? What would be an appropriate “feedback” response?
SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an Avenger.pdf
SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an Avenger.pdf
Ajaz Hussain
<NEURAL GP Networkとは> 島根県初・総合診療医育成プロジェクト 地域医療現場と大学を結ぶTeal型組織構造 診療医療の育成は現場においてのみ可能である。 しかし、現場だけでは日本全体の総合診療を成長させるには不十分。 だから、わたしたちは今、 島根県からITを駆使して総合医療のニューラルネットワーク構築を目指します。 NEURAL GP Network WEBサイト: https://shimanegp.com/
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Was ist angesagt?
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification. In this webinar, you will learn to: • Focus on practical QbD terms and approaches • Highlight critical product quality aspects of sterile medicinal products • Develop design and control spaces for sterilizing filtration • Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production Abstract: Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
Quality by Design Principles Applied to Sterilizing Filtration by Michael Payne
Quality by Design Principles Applied to Sterilizing Filtration by Michael Payne
Merck Life Sciences
<NEURAL GP Networkとは> 島根県初・総合診療医育成プロジェクト 地域医療現場と大学を結ぶTeal型組織構造 診療医療の育成は現場においてのみ可能である。 しかし、現場だけでは日本全体の総合診療を成長させるには不十分。 だから、わたしたちは今、 島根県からITを駆使して総合医療のニューラルネットワーク構築を目指します。 NEURAL GP Network WEBサイト: https://shimanegp.com/
リンパ節腫脹 パート2 問診診断
リンパ節腫脹 パート2 問診診断
NEURALGPNETWORK
Participate in the interactive webinar: http://bit.ly/SU-ADCWebinar Challenges of ADC manufacturing can be tackled by adopting single-use technology. Solutions will be presented about how to overcome concerns and implement a processing platform, supported through a strong vendor-manufacturer relationship. Explore our webinar library: www.merckmillipore.com/webinars
Using Single-use Technology to Overcome the Challenges of ADC Processing
Using Single-use Technology to Overcome the Challenges of ADC Processing
Merck Life Sciences
As single-use technologies continue to expand in pharmaceutical manufacturing processes, the risk assessment for extractables and leachables becomes increasingly complex. Join this webinar to obtain guidance on how to perform risk evaluation on a process with multiple single-use components. A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps-- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk. This webinar will evaluate the different single-use components with respect to compatibility and extractables and leachables. A case study will be used to demonstrate the complexity and potential concerns when performing a risk evaluation on the manufacturing process. In this webinar, you will learn: - Risk assessment of extractables - Single-use component evaluation - Complexity when evaluating multiple assemblies
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...
MilliporeSigma
<NEURAL GP Networkとは> 島根県初・総合診療医育成プロジェクト 地域医療現場と大学を結ぶTeal型組織構造 診療医療の育成は現場においてのみ可能である。 しかし、現場だけでは日本全体の総合診療を成長させるには不十分。 だから、わたしたちは今、 島根県からITを駆使して総合医療のニューラルネットワーク構築を目指します。 NEURAL GP Network WEBサイト: https://shimanegp.com/
嘔気嘔吐 鑑別診断 パート1
嘔気嘔吐 鑑別診断 パート1
NEURALGPNETWORK
Manual de Fotografia 1
Manual de Fotografia 1
Raquel Salcedo Gomes
Watch the presentation of this webinar here: https://bit.ly/3tDy8Ei Recent PDA/BioPhorum publications outline risks for PUPSIT in sterilizing filtration. This webinar will summarize the key points and best practices for implementing PUPSIT. PDA and BioPhorum have partnered to form a task force whose goal was to provide the industry and regulators with scientific data and analysis on the potential risks and benefits of implementing PUPSIT to improve sterility assurance. This webinar will describe the data generated by the task force studies and discuss considerations and best practices when implementing PUPSIT. In this webinar, you will learn: • How changing industry perspectives help overcome regulatory concerns and may influence regulatory perspective • How improved process understanding affects risk assessment • How improved final fill assembly design simplifies PUPSIT
Does PUPSIT Reduce Risk for Sterile Filtration?
Does PUPSIT Reduce Risk for Sterile Filtration?
Merck Life Sciences
<NEURAL GP Networkとは> 島根県初・総合診療医育成プロジェクト 地域医療現場と大学を結ぶTeal型組織構造 診療医療の育成は現場においてのみ可能である。 しかし、現場だけでは日本全体の総合診療を成長させるには不十分。 だから、わたしたちは今、 島根県からITを駆使して総合医療のニューラルネットワーク構築を目指します。 NEURAL GP Network WEBサイト: https://shimanegp.com/
嘔気嘔吐 問診診断 パート2
嘔気嘔吐 問診診断 パート2
NEURALGPNETWORK
Why did the company not design and formulate a tablet that did not “cap”? Why wouldn’t NIH fund my proposal for CAFD? Why did the FDA [discount] Pharmaceutical Development Reports, while in the EU and Japan, is it an essential part of the regulatory review? Under a hypothetical social inspection scheme, a report submitted in 2010 is imagined as PM 483 in the spirit of FDA Form 483 of “Inspectional Observations.” What do the noted observations suggest about my professional maturity or state of mind at that event in 2010? What would be an appropriate “feedback” response?
SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an Avenger.pdf
SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an Avenger.pdf
Ajaz Hussain
<NEURAL GP Networkとは> 島根県初・総合診療医育成プロジェクト 地域医療現場と大学を結ぶTeal型組織構造 診療医療の育成は現場においてのみ可能である。 しかし、現場だけでは日本全体の総合診療を成長させるには不十分。 だから、わたしたちは今、 島根県からITを駆使して総合医療のニューラルネットワーク構築を目指します。 NEURAL GP Network WEBサイト: https://shimanegp.com/
体重増加 パート1
体重増加 パート1
NEURALGPNETWORK
Jafuji
Jafuji
angelochintu
хвороби слизових сумок
хвороби слизових сумок
хвороби слизових сумок
demon4ik demon4ik
Was ist angesagt?
(12)
Quality by Design Principles Applied to Sterilizing Filtration by Michael Payne
Quality by Design Principles Applied to Sterilizing Filtration by Michael Payne
リンパ節腫脹 パート2 問診診断
リンパ節腫脹 パート2 問診診断
Using Single-use Technology to Overcome the Challenges of ADC Processing
Using Single-use Technology to Overcome the Challenges of ADC Processing
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...
嘔気嘔吐 鑑別診断 パート1
嘔気嘔吐 鑑別診断 パート1
Manual de Fotografia 1
Manual de Fotografia 1
Does PUPSIT Reduce Risk for Sterile Filtration?
Does PUPSIT Reduce Risk for Sterile Filtration?
嘔気嘔吐 問診診断 パート2
嘔気嘔吐 問診診断 パート2
SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an Avenger.pdf
SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an Avenger.pdf
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Wundbeurteilung
1.
Wundbeurteilung „Damit wir alle
vom Selben reden“
2.
Wundbeurteilung
3.
Wundbeurteilung Wundareale Wundgrund Wundrand Wundumgebung
4.
Wundbeurteilung Wundgrund Definition: Wunde ohne Epithel
5.
Wundbeurteilung Wundgrund Nekrotisch Belegt Granulierend Epithelisierend
6.
Erkennen - Symptomatik Wundgrund: –
schmierig – fibrinös belegt – nass; feucht; trocken – nekrotisch
7.
Wundbeurteilung Topografie Wundgrund • glatt •
höckrig • zerfetzt
8.
Wundbeurteilung Wundrand Definition: Wundnahe linienförmige epithelisierende Übergangszone (1
– 2 mm) der Wundumgebung.
9.
Wundbeurteilung Wundrand
10.
Wundbeurteilung Topografie Wundrand - glatt -
unregelmäßig - zerfetzt - wallartig - ödematös - gestanzt - unterminiert
11.
Erkennen - Symptomatik •
Wundränder: – gerötet – aufgeworfen (Schlauchbootrand) – mazeriert – Wundtasche
12.
Wundrand
13.
Wundrand
14.
Wundbeurteilung Wundumgebung Definition: Über den Wundrand
hinaus reichende, klinisch veränderte Hautareale (z.B. Irritation, Mazeration, Atrophie,…)
15.
Wundbeurteilung Wundumgebung
16.
Wundbeurteilung Topografie – Wundumgebung -
Ödem - entzündliche Schwellung - Einschnürung
17.
Wundbeurteilung Wundexsudat Definition: Wundexsudat ist durch
Entzündung bedingter Austritt von Flüssigkeit (ggf. auch Zellen) aus den Lymph- und Blutgefäßen
18.
Wundexsudat Farbe Klar Gelblich Rötlich Gelb Konsistenz Flüssig Flüssig Flüssig Cremig Charakter Serös Fibrinös Blutig Eitrig, purulent
19.
Wundbeurteilung Weitere Beurteilungsfaktoren: - Wundverfärbung
– z.B. Pseudomonas - Wundgeruch – z.B. Enterokokken - Wundabstrich
20.
Wundbeurteilung Danke für die Aufmerksam keit!!!
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