際際滷shows by User: ComplianceTrainings / http://www.slideshare.net/images/logo.gif 際際滷shows by User: ComplianceTrainings / Tue, 01 Oct 2013 09:39:17 GMT 際際滷Share feed for 際際滷shows by User: ComplianceTrainings Project Management for Computer Systems Validation /slideshow/project-mgt-csv/26744791 projectmgtcsv-131001093917-phpapp01
Scheduled On : Thursday, November 7, 2013 at 12:00 noon Duration: 120 minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=IT1050]]>

Scheduled On : Thursday, November 7, 2013 at 12:00 noon Duration: 120 minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=IT1050]]>
Tue, 01 Oct 2013 09:39:17 GMT /slideshow/project-mgt-csv/26744791 ComplianceTrainings@slideshare.net(ComplianceTrainings) Project Management for Computer Systems Validation ComplianceTrainings Scheduled On : Thursday, November 7, 2013 at 12:00 noon Duration: 120 minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=IT1050 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/projectmgtcsv-131001093917-phpapp01-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Scheduled On : Thursday, November 7, 2013 at 12:00 noon Duration: 120 minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=IT1050
Project Management for Computer Systems Validation from Anita Anzo
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Cleaning Validations Using Extraction Techniques /slideshow/cleaning-validation-26744588/26744588 cleaningvalidation-131001093536-phpapp02
Scheduled On : Monday, November 4, 2013 at 1:00 PM EDT Duration: 60 minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1141]]>

Scheduled On : Monday, November 4, 2013 at 1:00 PM EDT Duration: 60 minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1141]]>
Tue, 01 Oct 2013 09:35:36 GMT /slideshow/cleaning-validation-26744588/26744588 ComplianceTrainings@slideshare.net(ComplianceTrainings) Cleaning Validations Using Extraction Techniques ComplianceTrainings Scheduled On : Monday, November 4, 2013 at 1:00 PM EDT Duration: 60 minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1141 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/cleaningvalidation-131001093536-phpapp02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Scheduled On : Monday, November 4, 2013 at 1:00 PM EDT Duration: 60 minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1141
Cleaning Validations Using Extraction Techniques from Anita Anzo
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21 CFR 11 Compliance for Excel Spreadsheets /slideshow/21-cfr-excel-26706091/26706091 21cfrexcel-130930133953-phpapp02
Scheduled On : Tuesday, October 22, 2013 at 12:00 noon EDT Duration: 120 Minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1051 ]]>

Scheduled On : Tuesday, October 22, 2013 at 12:00 noon EDT Duration: 120 Minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1051 ]]>
Mon, 30 Sep 2013 13:39:53 GMT /slideshow/21-cfr-excel-26706091/26706091 ComplianceTrainings@slideshare.net(ComplianceTrainings) 21 CFR 11 Compliance for Excel Spreadsheets ComplianceTrainings Scheduled On : Tuesday, October 22, 2013 at 12:00 noon EDT Duration: 120 Minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1051 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/21cfrexcel-130930133953-phpapp02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Scheduled On : Tuesday, October 22, 2013 at 12:00 noon EDT Duration: 120 Minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1051
21 CFR 11 Compliance for Excel Spreadsheets from Anita Anzo
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Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration /ComplianceTrainings/creating-design-history-files-dhf-the-device-master-records-dmr-and-the-device-history-records-dhr-utilizing-the-principles-of-lean-documents-and-lean-configuration dhfdmrdhrlean-130930132703-phpapp01
Scheduled On : Friday, October 18, 2013 at 1:00 PM EDT Duration: 60 minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1042 ]]>

Scheduled On : Friday, October 18, 2013 at 1:00 PM EDT Duration: 60 minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1042 ]]>
Mon, 30 Sep 2013 13:27:03 GMT /ComplianceTrainings/creating-design-history-files-dhf-the-device-master-records-dmr-and-the-device-history-records-dhr-utilizing-the-principles-of-lean-documents-and-lean-configuration ComplianceTrainings@slideshare.net(ComplianceTrainings) Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration ComplianceTrainings Scheduled On : Friday, October 18, 2013 at 1:00 PM EDT Duration: 60 minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1042 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/dhfdmrdhrlean-130930132703-phpapp01-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Scheduled On : Friday, October 18, 2013 at 1:00 PM EDT Duration: 60 minutes this webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1042
Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration from Anita Anzo
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510k for IVDs /slideshow/510-k-ivd/26705493 510kivd-130930132450-phpapp01
Scheduled On : Tuesday, October 15, 2013 at 1:00 PM EDT Duration: 60 minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1112]]>

Scheduled On : Tuesday, October 15, 2013 at 1:00 PM EDT Duration: 60 minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1112]]>
Mon, 30 Sep 2013 13:24:50 GMT /slideshow/510-k-ivd/26705493 ComplianceTrainings@slideshare.net(ComplianceTrainings) 510k for IVDs ComplianceTrainings Scheduled On : Tuesday, October 15, 2013 at 1:00 PM EDT Duration: 60 minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1112 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/510kivd-130930132450-phpapp01-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Scheduled On : Tuesday, October 15, 2013 at 1:00 PM EDT Duration: 60 minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1112
510k for IVDs from Anita Anzo
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Acceptance Activities in FDA QSR /slideshow/acceptance-activities-in-fda-qsr/26705355 fdaqsr-130930132039-phpapp02
Scheduled On : Thursday, October 10, 2013 at 01:00 PM EDT Duration: 90 Minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1130]]>

Scheduled On : Thursday, October 10, 2013 at 01:00 PM EDT Duration: 90 Minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1130]]>
Mon, 30 Sep 2013 13:20:39 GMT /slideshow/acceptance-activities-in-fda-qsr/26705355 ComplianceTrainings@slideshare.net(ComplianceTrainings) Acceptance Activities in FDA QSR ComplianceTrainings Scheduled On : Thursday, October 10, 2013 at 01:00 PM EDT Duration: 90 Minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1130 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/fdaqsr-130930132039-phpapp02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Scheduled On : Thursday, October 10, 2013 at 01:00 PM EDT Duration: 90 Minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1130
Acceptance Activities in FDA QSR from Anita Anzo
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Marketing FDA Regulated Products Through Social Media /slideshow/marketing-fda-regulated-products/26705091 marketingfdaregulatedproducts-130930131424-phpapp01
Scheduled On Wednesday, October 9, 2013 at 01:00 PM EDT Duration: 90 minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1103]]>

Scheduled On Wednesday, October 9, 2013 at 01:00 PM EDT Duration: 90 minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1103]]>
Mon, 30 Sep 2013 13:14:24 GMT /slideshow/marketing-fda-regulated-products/26705091 ComplianceTrainings@slideshare.net(ComplianceTrainings) Marketing FDA Regulated Products Through Social Media ComplianceTrainings Scheduled On Wednesday, October 9, 2013 at 01:00 PM EDT Duration: 90 minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1103 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/marketingfdaregulatedproducts-130930131424-phpapp01-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Scheduled On Wednesday, October 9, 2013 at 01:00 PM EDT Duration: 90 minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1103
Marketing FDA Regulated Products Through Social Media from Anita Anzo
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21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration /slideshow/21-cfr-820-23249541/23249541 21cfr820-130620114215-phpapp02
Scheduled On : Wednesday, July 24, 2013 at 1:00 PM EDT Duration : 60 Minutes In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices.]]>

Scheduled On : Wednesday, July 24, 2013 at 1:00 PM EDT Duration : 60 Minutes In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices.]]>
Thu, 20 Jun 2013 11:42:15 GMT /slideshow/21-cfr-820-23249541/23249541 ComplianceTrainings@slideshare.net(ComplianceTrainings) 21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration ComplianceTrainings Scheduled On : Wednesday, July 24, 2013 at 1:00 PM EDT Duration : 60 Minutes In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/21cfr820-130620114215-phpapp02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Scheduled On : Wednesday, July 24, 2013 at 1:00 PM EDT Duration : 60 Minutes In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices.
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration from Anita Anzo
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How to manage virtual employees and achieve real results any time any place /slideshow/how-to-manage-virtual-employees-and-achieve-real-results-any-time-any-place/23248913 howtomanagevirtualemployeesandachieverealresultsanytimeanyplace-130620112000-phpapp02
Scheduled On : Tuesday, July 23, 2013 at 1:00 PM EDT Duration: 60 minutes In this 60 minute webinar, Tamara shares actual work experience of being a successful remote employee and remote manager in less than ideal circumstances and learning through experimentation and error, the most effective development of everybody in an organization.]]>

Scheduled On : Tuesday, July 23, 2013 at 1:00 PM EDT Duration: 60 minutes In this 60 minute webinar, Tamara shares actual work experience of being a successful remote employee and remote manager in less than ideal circumstances and learning through experimentation and error, the most effective development of everybody in an organization.]]>
Thu, 20 Jun 2013 11:19:59 GMT /slideshow/how-to-manage-virtual-employees-and-achieve-real-results-any-time-any-place/23248913 ComplianceTrainings@slideshare.net(ComplianceTrainings) How to manage virtual employees and achieve real results any time any place ComplianceTrainings Scheduled On : Tuesday, July 23, 2013 at 1:00 PM EDT Duration: 60 minutes In this 60 minute webinar, Tamara shares actual work experience of being a successful remote employee and remote manager in less than ideal circumstances and learning through experimentation and error, the most effective development of everybody in an organization. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/howtomanagevirtualemployeesandachieverealresultsanytimeanyplace-130620112000-phpapp02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Scheduled On : Tuesday, July 23, 2013 at 1:00 PM EDT Duration: 60 minutes In this 60 minute webinar, Tamara shares actual work experience of being a successful remote employee and remote manager in less than ideal circumstances and learning through experimentation and error, the most effective development of everybody in an organization.
How to manage virtual employees and achieve real results any time any place from Anita Anzo
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How to Manage a Product Medical Device Recall Efficiently and Effectively /slideshow/how-to-manage-a-product-medical-device-recall-efficiently-and-effectively-22987967/22987967 productrecall-130614131519-phpapp02
Scheduled On : Thursday, July 18, 2013 at 1:00 PM EDT This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.]]>

Scheduled On : Thursday, July 18, 2013 at 1:00 PM EDT This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.]]>
Fri, 14 Jun 2013 13:15:19 GMT /slideshow/how-to-manage-a-product-medical-device-recall-efficiently-and-effectively-22987967/22987967 ComplianceTrainings@slideshare.net(ComplianceTrainings) How to Manage a Product Medical Device Recall Efficiently and Effectively ComplianceTrainings Scheduled On : Thursday, July 18, 2013 at 1:00 PM EDT This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/productrecall-130614131519-phpapp02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Scheduled On : Thursday, July 18, 2013 at 1:00 PM EDT This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA&#39;s involvement.
How to Manage a Product Medical Device Recall Efficiently and Effectively from Anita Anzo
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Construct and manage the technical file and design dossier /ComplianceTrainings/construct-and-manage-the-technical-file-and-design-dossier-22985339 constructandmanagethetechnicalfileanddesigndossier-130614112928-phpapp01
Scheduled On : Tuesday, July 16, 2013 at 1:00 PM EDT This Webinar will provide a substantive overview and outline the differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. ]]>

Scheduled On : Tuesday, July 16, 2013 at 1:00 PM EDT This Webinar will provide a substantive overview and outline the differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. ]]>
Fri, 14 Jun 2013 11:29:28 GMT /ComplianceTrainings/construct-and-manage-the-technical-file-and-design-dossier-22985339 ComplianceTrainings@slideshare.net(ComplianceTrainings) Construct and manage the technical file and design dossier ComplianceTrainings Scheduled On : Tuesday, July 16, 2013 at 1:00 PM EDT This Webinar will provide a substantive overview and outline the differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/constructandmanagethetechnicalfileanddesigndossier-130614112928-phpapp01-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Scheduled On : Tuesday, July 16, 2013 at 1:00 PM EDT This Webinar will provide a substantive overview and outline the differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape.
Construct and manage the technical file and design dossier from Anita Anzo
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Creating Value: Employee Engagement at Work /slideshow/creating-value-22984877/22984877 creatingvalue-130614111623-phpapp01
Scheduled On Wednesday, July 10, 2013 at 1:00 PM EDT This detailed 90 minute discussion will cover the rules of engagement, what constitutes engagement, and the keys to insuring that once engaged it is in the right spirit for the right outcomes. Stepping through an entire engagement initiative, participants will engage in thoughts that will help them craft an engagement policy, program and objectives for success in their own company culture and with their own future. ]]>

Scheduled On Wednesday, July 10, 2013 at 1:00 PM EDT This detailed 90 minute discussion will cover the rules of engagement, what constitutes engagement, and the keys to insuring that once engaged it is in the right spirit for the right outcomes. Stepping through an entire engagement initiative, participants will engage in thoughts that will help them craft an engagement policy, program and objectives for success in their own company culture and with their own future. ]]>
Fri, 14 Jun 2013 11:16:23 GMT /slideshow/creating-value-22984877/22984877 ComplianceTrainings@slideshare.net(ComplianceTrainings) Creating Value: Employee Engagement at Work ComplianceTrainings Scheduled On Wednesday, July 10, 2013 at 1:00 PM EDT This detailed 90 minute discussion will cover the rules of engagement, what constitutes engagement, and the keys to insuring that once engaged it is in the right spirit for the right outcomes. Stepping through an entire engagement initiative, participants will engage in thoughts that will help them craft an engagement policy, program and objectives for success in their own company culture and with their own future. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/creatingvalue-130614111623-phpapp01-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Scheduled On Wednesday, July 10, 2013 at 1:00 PM EDT This detailed 90 minute discussion will cover the rules of engagement, what constitutes engagement, and the keys to insuring that once engaged it is in the right spirit for the right outcomes. Stepping through an entire engagement initiative, participants will engage in thoughts that will help them craft an engagement policy, program and objectives for success in their own company culture and with their own future.
Creating Value: Employee Engagement at Work from Anita Anzo
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The Hitchhikers guide to 483s and warning letters /slideshow/the-hitchhikers-guide-to-483s-and-warning-letters-20212577/20212577 thehitchhikersguideto483sandwarningletters-130429163050-phpapp02
Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain. A fun way to present this serious topic ! Whether your business can affect drug safety and effectiveness, Cosmetic and Medical specialized and consumer products your business is regulated by the FDA. With the FDA regulating a trillion worth of products each year, it is no wonder that audits by the FDA are perhaps the most intimidating of all events at a regulated facility. 483's and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection. In 2011 alone, there were 9288 product recalls, 16 Injunctions and 15 seizures. Can you afford not to be prepared ? This presentation will use humor to describe: > Why the FDA issues such citations > What is a 483 and what does it look like > What is a Warning letter and what does it look like > What is the difference between a 483 and a Warning Letter > What they mean for your company > How to respond to 483s and Warning Letters to avoid escalation by the FDA > How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters]]>

Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain. A fun way to present this serious topic ! Whether your business can affect drug safety and effectiveness, Cosmetic and Medical specialized and consumer products your business is regulated by the FDA. With the FDA regulating a trillion worth of products each year, it is no wonder that audits by the FDA are perhaps the most intimidating of all events at a regulated facility. 483's and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection. In 2011 alone, there were 9288 product recalls, 16 Injunctions and 15 seizures. Can you afford not to be prepared ? This presentation will use humor to describe: > Why the FDA issues such citations > What is a 483 and what does it look like > What is a Warning letter and what does it look like > What is the difference between a 483 and a Warning Letter > What they mean for your company > How to respond to 483s and Warning Letters to avoid escalation by the FDA > How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters]]>
Mon, 29 Apr 2013 16:30:50 GMT /slideshow/the-hitchhikers-guide-to-483s-and-warning-letters-20212577/20212577 ComplianceTrainings@slideshare.net(ComplianceTrainings) The Hitchhikers guide to 483s and warning letters ComplianceTrainings Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain. A fun way to present this serious topic ! Whether your business can affect drug safety and effectiveness, Cosmetic and Medical specialized and consumer products your business is regulated by the FDA. With the FDA regulating a trillion worth of products each year, it is no wonder that audits by the FDA are perhaps the most intimidating of all events at a regulated facility. 483's and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection. In 2011 alone, there were 9288 product recalls, 16 Injunctions and 15 seizures. Can you afford not to be prepared ? This presentation will use humor to describe: > Why the FDA issues such citations > What is a 483 and what does it look like > What is a Warning letter and what does it look like > What is the difference between a 483 and a Warning Letter > What they mean for your company > How to respond to 483s and Warning Letters to avoid escalation by the FDA > How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/thehitchhikersguideto483sandwarningletters-130429163050-phpapp02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain. A fun way to present this serious topic ! Whether your business can affect drug safety and effectiveness, Cosmetic and Medical specialized and consumer products your business is regulated by the FDA. With the FDA regulating a trillion worth of products each year, it is no wonder that audits by the FDA are perhaps the most intimidating of all events at a regulated facility. 483&#39;s and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection. In 2011 alone, there were 9288 product recalls, 16 Injunctions and 15 seizures. Can you afford not to be prepared ? This presentation will use humor to describe: &gt; Why the FDA issues such citations &gt; What is a 483 and what does it look like &gt; What is a Warning letter and what does it look like &gt; What is the difference between a 483 and a Warning Letter &gt; What they mean for your company &gt; How to respond to 483s and Warning Letters to avoid escalation by the FDA &gt; How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters
The Hitchhikers guide to 483s and warning letters from Anita Anzo
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