ºÝºÝߣshows by User: mswit / http://www.slideshare.net/images/logo.gif ºÝºÝߣshows by User: mswit / Thu, 10 Jan 2019 01:23:51 GMT ºÝºÝߣShare feed for ºÝºÝߣshows by User: mswit GMP Review -- Legal Letter from America Column -- How Data Integrity Issues Sunk The Fresenius-Akorn Merger /slideshow/gmp-review-legal-letter-from-america-column-how-data-integrity-issues-sunk-the-freseniusakorn-merger/127665531 switdataintegrityakorngmpreviewoctober2018-190110012351
Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management.]]>
Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management.]]> Thu, 10 Jan 2019 01:23:51 GMT /slideshow/gmp-review-legal-letter-from-america-column-how-data-integrity-issues-sunk-the-freseniusakorn-merger/127665531 mswit@slideshare.net(mswit) GMP Review -- Legal Letter from America Column -- How Data Integrity Issues Sunk The Fresenius-Akorn Merger mswit Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/switdataintegrityakorngmpreviewoctober2018-190110012351-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management.
GMP Review -- Legal Letter from America Column -- How Data Integrity Issues Sunk The Fresenius-Akorn Merger from Michael Swit
]]> 3741 5 https://cdn.slidesharecdn.com/ss_thumbnails/switdataintegrityakorngmpreviewoctober2018-190110012351-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 FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Compliance at the Company Level /slideshow/fda-regulation-of-promotion-advertising-part-8-handling-promotional-compliance-at-the-company-level-127264196/127264196 swc03f1-190104072756
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.]]>
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.]]> Fri, 04 Jan 2019 07:27:55 GMT /slideshow/fda-regulation-of-promotion-advertising-part-8-handling-promotional-compliance-at-the-company-level-127264196/127264196 mswit@slideshare.net(mswit) FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Compliance at the Company Level mswit Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/swc03f1-190104072756-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion &amp; Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Compliance at the Company Level from Michael Swit
]]> 671 1 https://cdn.slidesharecdn.com/ss_thumbnails/swc03f1-190104072756-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 Regulation of Promotion & Advertising -- Part 7: FTC Regulation /slideshow/fda-regulation-of-promotion-advertising-part-7-ftc-regulation-127264001/127264001 swit-advertisingandpromotion-november2018-part7-ftcregulation-190104072247
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, ]]>
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, ]]> Fri, 04 Jan 2019 07:22:46 GMT /slideshow/fda-regulation-of-promotion-advertising-part-7-ftc-regulation-127264001/127264001 mswit@slideshare.net(mswit) FDA Regulation of Promotion & Advertising -- Part 7: FTC Regulation mswit Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part7-ftcregulation-190104072247-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion &amp; Advertising of Drugs and Medical Devices,
FDA Regulation of Promotion & Advertising -- Part 7: FTC Regulation from Michael Swit
]]> 428 2 https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part7-ftcregulation-190104072247-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 Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-Label �and False Claims; Guidance on Medical Product Communications Consistent with Labeling /slideshow/fda-regulation-of-promotion-advertising-part-6-first-amendment-offlabel-and-false-claims-guidance-on-medical-product-communications-consistent-with-labeling-127263848/127263848 swd1a71-190104071832
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 2, 2018, Boston.]]>
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 2, 2018, Boston.]]> Fri, 04 Jan 2019 07:18:32 GMT /slideshow/fda-regulation-of-promotion-advertising-part-6-first-amendment-offlabel-and-false-claims-guidance-on-medical-product-communications-consistent-with-labeling-127263848/127263848 mswit@slideshare.net(mswit) FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-Label �and False Claims; Guidance on Medical Product Communications Consistent with Labeling mswit Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 2, 2018, Boston. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/swd1a71-190104071832-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion &amp; Advertising of Drugs and Medical Devices, November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-Label and False Claims; Guidance on Medical Product Communications Consistent with Labeling from Michael Swit
]]> 775 13 https://cdn.slidesharecdn.com/ss_thumbnails/swd1a71-190104071832-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 Regulation of Promotion & Advertising -- Part 5: Social Media & Internet /slideshow/fda-regulation-of-promotion-advertising-part-5-social-media-internet-127263574/127263574 swit-advertisingandpromotion-november2018-part5-socialmedia-190104071147
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston]]>
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston]]> Fri, 04 Jan 2019 07:11:47 GMT /slideshow/fda-regulation-of-promotion-advertising-part-5-social-media-internet-127263574/127263574 mswit@slideshare.net(mswit) FDA Regulation of Promotion & Advertising -- Part 5: Social Media & Internet mswit Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part5-socialmedia-190104071147-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion &amp; Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 5: Social Media & Internet from Michael Swit
]]> 471 9 https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part5-socialmedia-190104071147-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 Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Actions, Powers, & Consequences /slideshow/fda-regulation-of-promotion-advertising-part-4-fda-enforcement-actions-powers-consequences-127263385/127263385 swit-advertisingandpromotion-november2018-part4-fdaenforcement-190104070544
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.]]>
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.]]> Fri, 04 Jan 2019 07:05:44 GMT /slideshow/fda-regulation-of-promotion-advertising-part-4-fda-enforcement-actions-powers-consequences-127263385/127263385 mswit@slideshare.net(mswit) FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Actions, Powers, & Consequences mswit Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part4-fdaenforcement-190104070544-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion &amp; Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Actions, Powers, & Consequences from Michael Swit
]]> 512 4 https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part4-fdaenforcement-190104070544-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 Regulation of Promotion & Advertising -- Part 3: Disseminating Scientific Information /slideshow/fda-regulation-of-promotion-advertising-part-3-disseminating-scientific-information/127263233 swit-advertisingandpromotion-november2018-part3-disseminatingsciinfo-190104070148
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston ]]>
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston ]]> Fri, 04 Jan 2019 07:01:48 GMT /slideshow/fda-regulation-of-promotion-advertising-part-3-disseminating-scientific-information/127263233 mswit@slideshare.net(mswit) FDA Regulation of Promotion & Advertising -- Part 3: Disseminating Scientific Information mswit Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part3-disseminatingsciinfo-190104070148-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion &amp; Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 3: Disseminating Scientific Information from Michael Swit
]]> 816 6 https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part3-disseminatingsciinfo-190104070148-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 Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer Ads /slideshow/fda-regulation-of-promotion-advertising-part-2-directtoconsumer-ads-127263083/127263083 swit-advertisingandpromotion-november2018-part2-directtoconsumerads-190104065727
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 1-2, 2018, Boston]]>
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 1-2, 2018, Boston]]> Fri, 04 Jan 2019 06:57:27 GMT /slideshow/fda-regulation-of-promotion-advertising-part-2-directtoconsumer-ads-127263083/127263083 mswit@slideshare.net(mswit) FDA Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer Ads mswit Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 1-2, 2018, Boston <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part2-directtoconsumerads-190104065727-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion &amp; Advertising of Drugs and Medical Devices,November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer Ads from Michael Swit
]]> 489 2 https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part2-directtoconsumerads-190104065727-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 Regulation of Promotion & Advertising -- Part 1: The Basics /slideshow/fda-regulation-of-promotion-advertising-part-1-the-basics-127262888/127262888 swit-advertisingandpromotion-november2018-part1-thebasics-190104065156
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.]]>
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.]]> Fri, 04 Jan 2019 06:51:56 GMT /slideshow/fda-regulation-of-promotion-advertising-part-1-the-basics-127262888/127262888 mswit@slideshare.net(mswit) FDA Regulation of Promotion & Advertising -- Part 1: The Basics mswit Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part1-thebasics-190104065156-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion &amp; Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 1: The Basics from Michael Swit
]]> 488 5 https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part1-thebasics-190104065156-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 Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for Start-Ups /mswit/ensuring-fda-regulatory-success-for-biomedical-companies-key-lessons-for-startups ocrauciswitstartups20181025-181128074209
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation ]]>
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation ]]> Wed, 28 Nov 2018 07:42:09 GMT /mswit/ensuring-fda-regulatory-success-for-biomedical-companies-key-lessons-for-startups mswit@slideshare.net(mswit) Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for Start-Ups mswit Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ocrauciswitstartups20181025-181128074209-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Supporting Materials for Michael Swit&#39;s Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for Start-Ups from Michael Swit
]]> 1306 5 https://cdn.slidesharecdn.com/ss_thumbnails/ocrauciswitstartups20181025-181128074209-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 Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Successful Transactions /slideshow/regulatory-quality-clinical-due-diligence-the-oft-overlooked-keys-to-successful-transactions/124109038 6-181127003901
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.]]>
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.]]> Tue, 27 Nov 2018 00:39:01 GMT /slideshow/regulatory-quality-clinical-due-diligence-the-oft-overlooked-keys-to-successful-transactions/124109038 mswit@slideshare.net(mswit) Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Successful Transactions mswit June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/6-181127003901-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Successful Transactions from Michael Swit
]]> 323 4 https://cdn.slidesharecdn.com/ss_thumbnails/6-181127003901-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 Quality Considerations in Due Diligence for Pharmaceutical Transactions /slideshow/quality-considerations-in-due-diligence-for-pharmaceutical-transactions/120477918 switqualityconsiderationsinduediligencev12june2011-181023200329
June 2011 presentation to the Drug Information Association (DIA) Annual Conference in Chicago.]]>
June 2011 presentation to the Drug Information Association (DIA) Annual Conference in Chicago.]]> Tue, 23 Oct 2018 20:03:29 GMT /slideshow/quality-considerations-in-due-diligence-for-pharmaceutical-transactions/120477918 mswit@slideshare.net(mswit) Quality Considerations in Due Diligence for Pharmaceutical Transactions mswit June 2011 presentation to the Drug Information Association (DIA) Annual Conference in Chicago. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/switqualityconsiderationsinduediligencev12june2011-181023200329-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> June 2011 presentation to the Drug Information Association (DIA) Annual Conference in Chicago.
Quality Considerations in Due Diligence for Pharmaceutical Transactions from Michael Swit
]]> 556 2 https://cdn.slidesharecdn.com/ss_thumbnails/switqualityconsiderationsinduediligencev12june2011-181023200329-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 Inspections: Handling the Administrative and Legal Consequences -- Understanding How Ugly It Can Get /slideshow/fda-inspections-handling-the-administrative-and-legal-consequences-understanding-how-ugly-it-can-get/120253931 magi2018westswitconsequencesofinspectionsworkshop-181022041722
October 21, 2018 presentation to Master Class on Regulatory Compliance at the MAGI Clinical Research Conference -- 2018 West, San Diego]]>
October 21, 2018 presentation to Master Class on Regulatory Compliance at the MAGI Clinical Research Conference -- 2018 West, San Diego]]> Mon, 22 Oct 2018 04:17:22 GMT /slideshow/fda-inspections-handling-the-administrative-and-legal-consequences-understanding-how-ugly-it-can-get/120253931 mswit@slideshare.net(mswit) FDA Inspections: Handling the Administrative and Legal Consequences -- Understanding How Ugly It Can Get mswit October 21, 2018 presentation to Master Class on Regulatory Compliance at the MAGI Clinical Research Conference -- 2018 West, San Diego <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/magi2018westswitconsequencesofinspectionsworkshop-181022041722-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> October 21, 2018 presentation to Master Class on Regulatory Compliance at the MAGI Clinical Research Conference -- 2018 West, San Diego
FDA Inspections: Handling the Administrative and Legal Consequences -- Understanding How Ugly It Can Get from Michael Swit
]]> 228 4 https://cdn.slidesharecdn.com/ss_thumbnails/magi2018westswitconsequencesofinspectionsworkshop-181022041722-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 Regulation of Advertising of Diagnostics, RUO Products, and Laboratory Developed Tests /slideshow/fda-regulation-of-advertising-of-diagnostics-ruo-products-and-laboratory-developed-tests/119640413 ivdruoldtadvertisingregulationsswit20181003-181016195457
October 16, 2018 presentation to the Food & Drug Law Institute (FDLI) Conference on Advertising & Promotion in Washington, D.C.]]>
October 16, 2018 presentation to the Food & Drug Law Institute (FDLI) Conference on Advertising & Promotion in Washington, D.C.]]> Tue, 16 Oct 2018 19:54:57 GMT /slideshow/fda-regulation-of-advertising-of-diagnostics-ruo-products-and-laboratory-developed-tests/119640413 mswit@slideshare.net(mswit) FDA Regulation of Advertising of Diagnostics, RUO Products, and Laboratory Developed Tests mswit October 16, 2018 presentation to the Food & Drug Law Institute (FDLI) Conference on Advertising & Promotion in Washington, D.C. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ivdruoldtadvertisingregulationsswit20181003-181016195457-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> October 16, 2018 presentation to the Food &amp; Drug Law Institute (FDLI) Conference on Advertising &amp; Promotion in Washington, D.C.
FDA Regulation of Advertising of Diagnostics, RUO Products, and Laboratory Developed Tests from Michael Swit
]]> 2421 7 https://cdn.slidesharecdn.com/ss_thumbnails/ivdruoldtadvertisingregulationsswit20181003-181016195457-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 Basics of FDA Regulation of Device & IVD Advertising /slideshow/basics-of-fda-regulation-of-device-ivd-advertising/119639993 deviceivdpromobasicsswit20181003-181016195013
October 16, 2018 presentation to the Food & Drug Law Institute (FDLI) Conference on Advertising & Promotion in Washington, D.C.]]>
October 16, 2018 presentation to the Food & Drug Law Institute (FDLI) Conference on Advertising & Promotion in Washington, D.C.]]> Tue, 16 Oct 2018 19:50:12 GMT /slideshow/basics-of-fda-regulation-of-device-ivd-advertising/119639993 mswit@slideshare.net(mswit) Basics of FDA Regulation of Device & IVD Advertising mswit October 16, 2018 presentation to the Food & Drug Law Institute (FDLI) Conference on Advertising & Promotion in Washington, D.C. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/deviceivdpromobasicsswit20181003-181016195013-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> October 16, 2018 presentation to the Food &amp; Drug Law Institute (FDLI) Conference on Advertising &amp; Promotion in Washington, D.C.
Basics of FDA Regulation of Device & IVD Advertising from Michael Swit
]]> 420 3 https://cdn.slidesharecdn.com/ss_thumbnails/deviceivdpromobasicsswit20181003-181016195013-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 Presentation on Critical Legal Issues Facing GMP Compliance /slideshow/presentation-on-critical-legal-issues-facing-gmp-compliance/111979475 swit-gmpbytheseacriticallegalissuesaugust2018-180828184658
August 27, 2018 Presentation to the 23rd Annual GMP by the Sea Conference in Cambridge, Maryland, focusing on the potential legal consequences faced by companies that violate FDA's requirements on Good Manufacturing Practices (GMPs) for drugs and biologics]]>
August 27, 2018 Presentation to the 23rd Annual GMP by the Sea Conference in Cambridge, Maryland, focusing on the potential legal consequences faced by companies that violate FDA's requirements on Good Manufacturing Practices (GMPs) for drugs and biologics]]> Tue, 28 Aug 2018 18:46:58 GMT /slideshow/presentation-on-critical-legal-issues-facing-gmp-compliance/111979475 mswit@slideshare.net(mswit) Presentation on Critical Legal Issues Facing GMP Compliance mswit August 27, 2018 Presentation to the 23rd Annual GMP by the Sea Conference in Cambridge, Maryland, focusing on the potential legal consequences faced by companies that violate FDA's requirements on Good Manufacturing Practices (GMPs) for drugs and biologics <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/swit-gmpbytheseacriticallegalissuesaugust2018-180828184658-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> August 27, 2018 Presentation to the 23rd Annual GMP by the Sea Conference in Cambridge, Maryland, focusing on the potential legal consequences faced by companies that violate FDA&#39;s requirements on Good Manufacturing Practices (GMPs) for drugs and biologics
Presentation on Critical Legal Issues Facing GMP Compliance from Michael Swit
]]> 926 8 https://cdn.slidesharecdn.com/ss_thumbnails/swit-gmpbytheseacriticallegalissuesaugust2018-180828184658-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 Overview of FDA Drug Manufacturing Requirements /slideshow/overview-of-fda-drug-manufacturing-requirements/107774876 switfdliintrotodrugsmanufacturingjuly2018-180728001648
Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food & Drug Law Institute (FDLI) on July 25, 2018 in San Francisco.]]>
Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food & Drug Law Institute (FDLI) on July 25, 2018 in San Francisco.]]> Sat, 28 Jul 2018 00:16:48 GMT /slideshow/overview-of-fda-drug-manufacturing-requirements/107774876 mswit@slideshare.net(mswit) Overview of FDA Drug Manufacturing Requirements mswit Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food & Drug Law Institute (FDLI) on July 25, 2018 in San Francisco. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/switfdliintrotodrugsmanufacturingjuly2018-180728001648-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food &amp; Drug Law Institute (FDLI) on July 25, 2018 in San Francisco.
Overview of FDA Drug Manufacturing Requirements from Michael Swit
]]> 1220 4 https://cdn.slidesharecdn.com/ss_thumbnails/switfdliintrotodrugsmanufacturingjuly2018-180728001648-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 "Scientific Exchange -- New Interpretations??" /mswit/scientific-exchange-new-interpretations diacommunity-adpromojuly20182novs-swit-sciexfinalaseditedbymichaelafterdia-180728000523
Presentation to the DIA Regulatory Affairs Community AdPromo Working Group webinar on July 25, 2018 on FDA's Regulation of Scientific Exchange]]>
Presentation to the DIA Regulatory Affairs Community AdPromo Working Group webinar on July 25, 2018 on FDA's Regulation of Scientific Exchange]]> Sat, 28 Jul 2018 00:05:23 GMT /mswit/scientific-exchange-new-interpretations mswit@slideshare.net(mswit) "Scientific Exchange -- New Interpretations??" mswit Presentation to the DIA Regulatory Affairs Community AdPromo Working Group webinar on July 25, 2018 on FDA's Regulation of Scientific Exchange <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/diacommunity-adpromojuly20182novs-swit-sciexfinalaseditedbymichaelafterdia-180728000523-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation to the DIA Regulatory Affairs Community AdPromo Working Group webinar on July 25, 2018 on FDA&#39;s Regulation of Scientific Exchange
"Scientific Exchange -- New Interpretations??" from Michael Swit
]]> 1244 8 https://cdn.slidesharecdn.com/ss_thumbnails/diacommunity-adpromojuly20182novs-swit-sciexfinalaseditedbymichaelafterdia-180728000523-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 Combination Products, Orphan Drugs, and OTC Drugs /slideshow/combination-products-orphan-drugs-and-otc-drugs-107773826/107773826 swit-sdranracstudycourse-2018-combproducts-orphans-otcs-180727235306
Presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Exam review course on FDA regulation of combination products, orphan drugs, and OTC drugs.]]>
Presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Exam review course on FDA regulation of combination products, orphan drugs, and OTC drugs.]]> Fri, 27 Jul 2018 23:53:06 GMT /slideshow/combination-products-orphan-drugs-and-otc-drugs-107773826/107773826 mswit@slideshare.net(mswit) Combination Products, Orphan Drugs, and OTC Drugs mswit Presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Exam review course on FDA regulation of combination products, orphan drugs, and OTC drugs. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/swit-sdranracstudycourse-2018-combproducts-orphans-otcs-180727235306-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Exam review course on FDA regulation of combination products, orphan drugs, and OTC drugs.
Combination Products, Orphan Drugs, and OTC Drugs from Michael Swit
]]> 916 11 https://cdn.slidesharecdn.com/ss_thumbnails/swit-sdranracstudycourse-2018-combproducts-orphans-otcs-180727235306-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 Latest Developments in and the Future of the Regulatory Landscape for Approving Treatments for Orphan and Rare Diseases. /slideshow/latest-developments-in-and-the-future-of-the-regulatory-landscape-for-approving-treatments-for-orphan-and-rare-diseases/103372468 swit-pge-orphandrugsjune252018-180628025746
Presentation on "Latest Developments in and the Future of the Regulatory Landscape for Approving Treatments for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference. June 25, 2018. San Diego, CA. ]]>
Presentation on "Latest Developments in and the Future of the Regulatory Landscape for Approving Treatments for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference. June 25, 2018. San Diego, CA. ]]> Thu, 28 Jun 2018 02:57:46 GMT /slideshow/latest-developments-in-and-the-future-of-the-regulatory-landscape-for-approving-treatments-for-orphan-and-rare-diseases/103372468 mswit@slideshare.net(mswit) Latest Developments in and the Future of the Regulatory Landscape for Approving Treatments for Orphan and Rare Diseases. mswit Presentation on "Latest Developments in and the Future of the Regulatory Landscape for Approving Treatments for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference. June 25, 2018. San Diego, CA. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/swit-pge-orphandrugsjune252018-180628025746-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on &quot;Latest Developments in and the Future of the Regulatory Landscape for Approving Treatments for Orphan and Rare Diseases,&quot; given at the Orphan Drugs &amp; Rare Diseases -- 2018 Americas West Coast Conference. June 25, 2018. San Diego, CA.
Latest Developments in and the Future of the Regulatory Landscape for Approving Treatments for Orphan and Rare Diseases. from Michael Swit
]]> 542 9 https://cdn.slidesharecdn.com/ss_thumbnails/swit-pge-orphandrugsjune252018-180628025746-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-mswit-48x48.jpg?cb=1646172353 Michael A. Swit, Esq., Principal in the San Diego-based Law Offices of Michael A. Swit, is a highly-experienced food & drug law attorney who has been been addressing critical FDA legal issues since 1984. His vast experience includes serving as the chief regulatory lawyer at Illumina, Inc., the world's leading developer of gene sequencing technology; as general counsel and secretary of Par Pharmaceutical, a prominent generic drug company and stints as Special Counsel in the FDA Law Practices of Duane Morris LLP, Heller Ehrman, and McKenna & Cuneo (now Denton's). Mr. Swit has taught and written on a array of subjects relating to FDA law, regulation and related commercial activities, www.fdacounsel.com https://cdn.slidesharecdn.com/ss_thumbnails/switdataintegrityakorngmpreviewoctober2018-190110012351-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/gmp-review-legal-letter-from-america-column-how-data-integrity-issues-sunk-the-freseniusakorn-merger/127665531 GMP Review -- Legal Le... https://cdn.slidesharecdn.com/ss_thumbnails/swc03f1-190104072756-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/fda-regulation-of-promotion-advertising-part-8-handling-promotional-compliance-at-the-company-level-127264196/127264196 FDA Regulation of Prom... https://cdn.slidesharecdn.com/ss_thumbnails/swit-advertisingandpromotion-november2018-part7-ftcregulation-190104072247-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/fda-regulation-of-promotion-advertising-part-7-ftc-regulation-127264001/127264001 FDA Regulation of Prom...