際際滷shows by User: kimsunkist / http://www.slideshare.net/images/logo.gif 際際滷shows by User: kimsunkist / Tue, 31 Mar 2015 07:08:34 GMT 際際滷Share feed for 際際滷shows by User: kimsunkist QbD in Generics IFPAC 2015 Teva Inna Ben Anat QbDWorks /slideshow/qbd-in-generics-ifpac-2015-teva-inna-ben-anat-qbd-works/46489602 qbdingenericsifpac2015tevainnabenanatqbdworks-150331070834-conversion-gate01
Listen to the Full Interview: http://qbdworks.com QbD in Generics - Interview with Inna Ben-Anat by QbDWorks.com]]>
Listen to the Full Interview: http://qbdworks.com QbD in Generics - Interview with Inna Ben-Anat by QbDWorks.com]]> Tue, 31 Mar 2015 07:08:34 GMT /slideshow/qbd-in-generics-ifpac-2015-teva-inna-ben-anat-qbd-works/46489602 kimsunkist@slideshare.net(kimsunkist) QbD in Generics IFPAC 2015 Teva Inna Ben Anat QbDWorks kimsunkist Listen to the Full Interview: http://qbdworks.com QbD in Generics - Interview with Inna Ben-Anat by QbDWorks.com <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/qbdingenericsifpac2015tevainnabenanatqbdworks-150331070834-conversion-gate01-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Listen to the Full Interview: http://qbdworks.com QbD in Generics - Interview with Inna Ben-Anat by QbDWorks.com
QbD in Generics IFPAC 2015 Teva Inna Ben Anat QbDWorks from Sun Kim
]]> 2050 6 https://cdn.slidesharecdn.com/ss_thumbnails/qbdingenericsifpac2015tevainnabenanatqbdworks-150331070834-conversion-gate01-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 FDA on Prefilled Syringes and Combination Products (Lana Shiu,MD) /slideshow/lana-shiumd/41751885 fyfhdxvcr6ax14gl3q53-signature-f32cb5e9d5009b8f22751989807de75b9f69f885c46af4b72c9db955aca30c3f-poli-141119070017-conversion-gate02
Audio at http://QbDWorks.com (Courtesy of Dr. Lana Shiu of FDA) I met Dr. Lana Shiu after her presentation at the PDA conference. She gladly agreed to share her talk with our QbDWorks community. What Dr. Shiu covers: Why FDA is focusing on Combination Products Now Why this applies to all of us Case study of failed combination product (prefilled syringe) Background of Combination Products governed by FDA Product Development Considerations Human Factors Considerations FDA Application Submission Guidelines Lessons Learned Key Steps to Successful Application At the end of this article are links to the FDA guidelines: Guidance Documents (finalized 2013) Drug or Biologic using Injectors/Prefilled Syringes Assembled into Injectors]]>
Audio at http://QbDWorks.com (Courtesy of Dr. Lana Shiu of FDA) I met Dr. Lana Shiu after her presentation at the PDA conference. She gladly agreed to share her talk with our QbDWorks community. What Dr. Shiu covers: Why FDA is focusing on Combination Products Now Why this applies to all of us Case study of failed combination product (prefilled syringe) Background of Combination Products governed by FDA Product Development Considerations Human Factors Considerations FDA Application Submission Guidelines Lessons Learned Key Steps to Successful Application At the end of this article are links to the FDA guidelines: Guidance Documents (finalized 2013) Drug or Biologic using Injectors/Prefilled Syringes Assembled into Injectors]]> Wed, 19 Nov 2014 07:00:17 GMT /slideshow/lana-shiumd/41751885 kimsunkist@slideshare.net(kimsunkist) FDA on Prefilled Syringes and Combination Products (Lana Shiu,MD) kimsunkist Audio at http://QbDWorks.com (Courtesy of Dr. Lana Shiu of FDA) I met Dr. Lana Shiu after her presentation at the PDA conference. She gladly agreed to share her talk with our QbDWorks community. What Dr. Shiu covers: Why FDA is focusing on Combination Products Now Why this applies to all of us Case study of failed combination product (prefilled syringe) Background of Combination Products governed by FDA Product Development Considerations Human Factors Considerations FDA Application Submission Guidelines Lessons Learned Key Steps to Successful Application At the end of this article are links to the FDA guidelines: Guidance Documents (finalized 2013) Drug or Biologic using Injectors/Prefilled Syringes Assembled into Injectors <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/fyfhdxvcr6ax14gl3q53-signature-f32cb5e9d5009b8f22751989807de75b9f69f885c46af4b72c9db955aca30c3f-poli-141119070017-conversion-gate02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Audio at http://QbDWorks.com (Courtesy of Dr. Lana Shiu of FDA) I met Dr. Lana Shiu after her presentation at the PDA conference. She gladly agreed to share her talk with our QbDWorks community. What Dr. Shiu covers: Why FDA is focusing on Combination Products Now Why this applies to all of us Case study of failed combination product (prefilled syringe) Background of Combination Products governed by FDA Product Development Considerations Human Factors Considerations FDA Application Submission Guidelines Lessons Learned Key Steps to Successful Application At the end of this article are links to the FDA guidelines: Guidance Documents (finalized 2013) Drug or Biologic using Injectors/Prefilled Syringes Assembled into Injectors
FDA on Prefilled Syringes and Combination Products (Lana Shiu,MD) from Sun Kim
]]> 27080 8 https://cdn.slidesharecdn.com/ss_thumbnails/fyfhdxvcr6ax14gl3q53-signature-f32cb5e9d5009b8f22751989807de75b9f69f885c46af4b72c9db955aca30c3f-poli-141119070017-conversion-gate02-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 First Step in QbD - How to Get it Right /slideshow/first-step-in-qbd-how-to-get-it-right-40305267/40305267 ispe2014-firststepinqbd-howtogetitright-141015100120-conversion-gate01
What is the most overlooked step in Quality by Design? QbD Risk Assessment - Learn the common pitfalls and how to prevent it. It's all about the relationship between your process parameter (CPP) and patient (QTPP)]]>
What is the most overlooked step in Quality by Design? QbD Risk Assessment - Learn the common pitfalls and how to prevent it. It's all about the relationship between your process parameter (CPP) and patient (QTPP)]]> Wed, 15 Oct 2014 10:01:20 GMT /slideshow/first-step-in-qbd-how-to-get-it-right-40305267/40305267 kimsunkist@slideshare.net(kimsunkist) First Step in QbD - How to Get it Right kimsunkist What is the most overlooked step in Quality by Design? QbD Risk Assessment - Learn the common pitfalls and how to prevent it. It's all about the relationship between your process parameter (CPP) and patient (QTPP) <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ispe2014-firststepinqbd-howtogetitright-141015100120-conversion-gate01-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> What is the most overlooked step in Quality by Design? QbD Risk Assessment - Learn the common pitfalls and how to prevent it. It&#39;s all about the relationship between your process parameter (CPP) and patient (QTPP)
First Step in QbD - How to Get it Right from Sun Kim
]]> 3638 5 https://cdn.slidesharecdn.com/ss_thumbnails/ispe2014-firststepinqbd-howtogetitright-141015100120-conversion-gate01-thumbnail.jpg?width=120&height=120&fit=bounds presentation 000000 http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 QbR: 2014 Vision by Director of ONDQA FDA /kimsunkist/qb-r-a-visionsoodr qbr-avisionsoodr-140212064921-phpapp02
QbR: A Vision by Director of ONDQA FDA]]>
QbR: A Vision by Director of ONDQA FDA]]> Wed, 12 Feb 2014 06:49:21 GMT /kimsunkist/qb-r-a-visionsoodr kimsunkist@slideshare.net(kimsunkist) QbR: 2014 Vision by Director of ONDQA FDA kimsunkist QbR: A Vision by Director of ONDQA FDA <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/qbr-avisionsoodr-140212064921-phpapp02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> QbR: A Vision by Director of ONDQA FDA
QbR: 2014 Vision by Director of ONDQA FDA from Sun Kim
]]> 2813 3 https://cdn.slidesharecdn.com/ss_thumbnails/qbr-avisionsoodr-140212064921-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds presentation White http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Risk assessment for Quality-by-Design and why FMEA fails /slideshow/risk-assessment-for-qb-d-3-reasons-why-fmea-fails/30573511 riskassessmentforqbd3reasonswhyfmeafails-140129055143-phpapp02
Risk assessment for Quality-by-Design and 3 Reasons why FMEA fails]]>
Risk assessment for Quality-by-Design and 3 Reasons why FMEA fails]]> Wed, 29 Jan 2014 05:51:43 GMT /slideshow/risk-assessment-for-qb-d-3-reasons-why-fmea-fails/30573511 kimsunkist@slideshare.net(kimsunkist) Risk assessment for Quality-by-Design and why FMEA fails kimsunkist Risk assessment for Quality-by-Design and 3 Reasons why FMEA fails <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/riskassessmentforqbd3reasonswhyfmeafails-140129055143-phpapp02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Risk assessment for Quality-by-Design and 3 Reasons why FMEA fails
Risk assessment for Quality-by-Design and why FMEA fails from Sun Kim
]]> 4517 8 https://cdn.slidesharecdn.com/ss_thumbnails/riskassessmentforqbd3reasonswhyfmeafails-140129055143-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 https://cdn.slidesharecdn.com/profile-photo-kimsunkist-48x48.jpg?cb=1581528699 Dr. Sun K. Kim is a Quality-by-Design Evangelist, transforming how Drug Development is executed in the Biologics, Pharmaceutical and Medical Devices industry. In addition, he teaches at Keio University and Stanford University. As founder of the largest global Quality-by-Design community forum, Sun's mission is to spread QbD and accelerate drug development. He received his MS and PhD at Stanford University. Sun was formerly a Professor at Keio University in Japan. Keywords: Quality by Design, Business Process Management, Design Thinking, Product-Service-Systems Design, Systems Design Education, Design for X (i.e.Manufacturing, Lean Six Sigma), Lean Product Development, Design of Exper... http://QbDWorks.com https://cdn.slidesharecdn.com/ss_thumbnails/qbdingenericsifpac2015tevainnabenanatqbdworks-150331070834-conversion-gate01-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/qbd-in-generics-ifpac-2015-teva-inna-ben-anat-qbd-works/46489602 QbD in Generics IFPAC ... https://cdn.slidesharecdn.com/ss_thumbnails/fyfhdxvcr6ax14gl3q53-signature-f32cb5e9d5009b8f22751989807de75b9f69f885c46af4b72c9db955aca30c3f-poli-141119070017-conversion-gate02-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/lana-shiumd/41751885 FDA on Prefilled Syrin... https://cdn.slidesharecdn.com/ss_thumbnails/ispe2014-firststepinqbd-howtogetitright-141015100120-conversion-gate01-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/first-step-in-qbd-how-to-get-it-right-40305267/40305267 First Step in QbD - Ho...