Event Promotional Campaigns





Member Bodies and Associates


THE IIER - 723rd International Conference on Social Science and Economics ICSSE

Toronto  Canada - 28th Sep 2019

2019 IIER 723rd International Conference on Social Science and Economics ICSSE will be held in Toronto, Canada during 28th - 29th September, 2019 as the Conference of ICSSE-2019. ICSSE 2019 is sponsored by International Institute of Engineers and Researchers IIER. It aims to be one of the leading international conferences for presenting novel and fundamental advances in the fields of Social Science and Economics. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Social Science and Economics related techniques.
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THE IIER - 616th International Conference on Law and Political ScienceICLPS

Toronto  Canada - 28th Sep 2019

2019 IIER 616th International Conference on Law and Political ScienceICLPS will be held in Toronto, Canada during 28th - 29th September, 2019 as the Conference of ICLPS-2019. ICLPS 2019 is sponsored by International Institute of Engineers and Researchers IIER. It aims to be one of the leading international conferences for presenting novel and fundamental advances in the fields of Law and Political Science. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Law and Political Science related techniques.
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IASTEM - 651st International Conference on Civil and Architectural Engineering ICCAE

Ottawa  Canada - 27th Jul 2019

IASTEM - 651st International Conference on Civil and Architectural Engineering ICCAE will be held on 27th - 28th July, 2019 at Ottawa, Canada . ICCAE is to bring together innovative academics and industrial experts in the field of Civil and Architectural Engineering to a common forum.
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IASTEM- 654th International Conference on Environment and Natural Science ICENS

Ottawa  Canada - 27th Jul 2019

IASTEM- 654th International Conference on Environment and Natural Science ICENS will be held on 27th - 28th July, 2019 at Ottawa, Canada . ICENS is to bring together innovative academics and industrial experts in the field of Environment and Natural Science to a common forum.
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RF - 499th International Conference on Medical & Health Science - ICMHS 2019

Kyoto  Japan - 27th Sep 2019

RF - 499th International Conference on Medical & Health Science - ICMHS 2019It will be held during 27th Sep 2019 at Kyoto , Kyoto , Japan organized by Researchfora The aim of the conference is to provide the platform for Students, Doctors, Researchers and Academicians to share the knowledge and ideas in the recent trends in the field of Medical & Health Science.
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RF - 480th International Conference on Management, Economics & Social Science - ICMESS 2019

Tokyo  Japan - 26th Aug 2019

RF - 480th International Conference on Management, Economics & Social Science - ICMESS 2019It will be held during 26th Aug 2019 at Tokyo , Tokyo , Japan organized by Researchfora The aim of the conference is to provide the platform for Students, Researchers and Academicians to share the knowledge and ideas in the recent trends in the field of Management, Economics & Social Science.
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THE IIER - 672nd International Conference on Science, Innovation and Management ICSIM

Kyoto  Japan - 27th Jul 2019

2019 IIER 672nd International Conference on Science, Innovation and Management ICSIM will be held in Kyoto, Japan during 27th - 28th July, 2019, as the Conference of ICSIM-2019. ICSIM 2019 is sponsored by International Institute of Engineers and Researchers IIER. It aims to be one of the leading international conferences for presenting novel and fundamental advances in the fields of Science, Innovation and Management. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Science, Innovation and Management related techniques.
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WETSCAPES Conference - Understanding the ecology of restored fen peatlands for protection and sustainable use

Rostock  Germany - 10th Sep 2019

Greenhouse gas exchange in space and time, Element cycling and export, Peatland bio-hydrology, Plant growth and decomposition, Microbial pathways, Paleoecological methods in restored peatlands, Legacy of degradation in biotic communities, Mapping with GIS and remote sensing
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THE IIER - 695th International Conference on Science, Innovation and Management ICSIM

Munich  Germany - 03rd Sep 2019

2019 IIER 695th International Conference on Science, Innovation and Management ICSIM will be held in Munich, Germany during 3rd - 4th September, 2019, as the Conference of ICSIM-2019. ICSIM 2019 is sponsored by International Institute of Engineers and Researchers IIER. It aims to be one of the leading international conferences for presenting novel and fundamental advances in the fields of Science, Innovation and Management. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Science, Innovation and Management related techniques.
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THE IIER - 708th International Conference on Natural Science and Environment ICNSE

Munich  Germany - 03rd Sep 2019

2019 IIER 708th International Conference on Natural Science and Environment ICNSE will be held in Munich, Germany during 3rd - 4th September, 2019 as the Conference of ICNSE-2019. ICNSE 2019 is sponsored by International Institute of Engineers and Researchers IIER. It aims to be one of the leading international conferences for presenting novel and fundamental advances in the fields of Natural Science and Environment. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Natural Science and Environment related techniques.
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IASTEM - 654th International Conference on Recent Advances in Engineering and Technology ICRAET

Frankfurt  Germany - 04th Aug 2019

IASTEM - 654th International Conference on Recent Advances in Engineering and Technology ICRAET will be held on 4th - 5th August, 2019 at Frankfurt, Germany . ICRAET is to bring together innovative academics and industrial experts in the field of Engineering and Technology to a common forum.
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IASTEM - 653rd International Conference on Economics and Business Management ICEBM

Berlin  Germany - 04th Aug 2019

IASTEM - 653rd International Conference on Economics and Business Management ICEBM will be held on 4th - 5th August, 2019 at Frankfurt, Germany . ICEBM is to bring together innovative academics and industrial experts in the field of Economics and Business Management to a common forum.
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IASTEM - 655th International Conference on Science Technology and Management ICSTM

Berlin  Germany - 02nd Aug 2019

IASTEM - 655th International Conference on Science Technology and Management ICSTM will be held on 2nd - 3rd August, 2019 at Berlin, Germany . ICSTM is to bring together innovative academics and industrial experts in the field of Science Technology and Management to a common forum.
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IEEE International Professional Communication Conference

Aachen  Germany - 23rd Jul 2019

Digitalization impacts and transforms all areas of our life – especially our work life. ProComm 2019 will examine the role of professional communication in the context of fast changing industrial branches and markets. ProComm 2019 welcomes papers, panels, and workshops addressing all areas of communication in professional and technical contexts, including but not limited to: Engineering communication, entrepreneurship communication, health communication, riskcrisis communication, energy communication.
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IEEE International Professional Communication Conference

Aachen  Germany - 23rd Jul 2019

Digitalization impacts and transforms all areas of our life – especially our work life. ProComm 2019 will examine the role of professional communication in the context of fast changing industrial branches and markets. ProComm 2019 welcomes papers, panels, and workshops addressing all areas of communication in professional and technical contexts, including but not limited to: Engineering communication, entrepreneurship communication, health communication, riskcrisis communication, energy communication.
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THE IIER - 697th International Conference on Social Science and Economics ICSSE

Seoul  Korea South - 18th Aug 2019

2019 IIER 697th International Conference on Social Science and Economics ICSSE will be held in Seoul, South Korea during 18th - 19th August, 2019 as the Conference of ICSSE-2019. ICSSE 2019 is sponsored by International Institute of Engineers and Researchers IIER. It aims to be one of the leading international conferences for presenting novel and fundamental advances in the fields of Social Science and Economics. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Social Science and Economics related techniques.
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THE IIER - 616th International Conference on Psychology, Language and Teaching ICPLT

Seoul  Korea South - 18th Aug 2019

2019 IIER 616th International Conference on Psychology, Language and Teaching ICPLT will be held in Seoul, South Korea during 18th - 19th August, 2019 as the Conference of ICPLT-2019. ICPLT 2019 is sponsored by International Institute of Engineers and Researchers IIER. It aims to be one of the leading international conferences for presenting novel and fundamental advances in the fields of Psychology, Language and Teaching. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Psychology, Language and Teaching related techniques.
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THE IIER - 590th International Conference on Law and Political ScienceICLPS

Seoul  Korea South - 18th Aug 2019

2019 IIER 590th International Conference on Law and Political ScienceICLPS will be held in Seoul, South Korea during 18th - 19th August, 2019 as the Conference of ICLPS-2019. ICLPS 2019 is sponsored by International Institute of Engineers and Researchers IIER. It aims to be one of the leading international conferences for presenting novel and fundamental advances in the fields of Law and Political Science. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Law and Political Science related techniques.
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RF - 498th International Conference on Science, Engineering & Technology - ICSET 2019

Johannesburg  South Africa - 25th Sep 2019

RF - 498th International Conference on Science, Engineering & Technology - ICSET 2019It will be held during 25th Sep 2019 at Johannesburg , Johannesburg , South Africa organized by Researchfora The aim of the conference is to provide the platform for Students, Engineers, Scientists, Researchers and Academicians to share the knowledge and ideas in the recent trends in the field of Science, Engineering & Technology.
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THE IIER - 671st International Conference on Science, Innovation and Management ICSIM

Johannesburg  South Africa - 25th Jul 2019

2019 IIER 671st International Conference on Science, Innovation and Management ICSIM will be held in Johannesburg, South Africa during 25th - 26th July, 2019, as the Conference of ICSIM-2019. ICSIM 2019 is sponsored by International Institute of Engineers and Researchers IIER. It aims to be one of the leading international conferences for presenting novel and fundamental advances in the fields of Science, Innovation and Management. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Science, Innovation and Management related techniques.
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World Conference Alerts Seminar

27 Jun 2019

28 Jun 2019

 

Effectively Addressing and Remediating FDAs Form 483 Findings com A

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Event Serial No.-  WLD100899
Website  
Contact Person - Kate Jobs
Event inquiry /Organizer email address - amazing-conference@outlook.com
Deadline for abstracts/proposals: 2019-06-27
Organized by: Amazing Conference INC View more Conference
Venue: Houston,  Texas,  United States of America

About Event


This seminar will guide the attendee in effectively handling, addressing and remediating FDAs and other related compliance issues associated such as FDAs Form 483, Warning Letter and Consent Decree Compliance Findings. An effective handling and resolution of Compliance issues will prevent further disciplinary actions such as an FDAs Warning Letter or a formal Consent Decree which ends with a costly impact, fines and possible injunctions by the FDA. Because the impact of non-compliance and remediation of compliance issues are very costly, time consuming and impacting to a business and associated manufactured product including an increasing severity of disciplinary action by the FDA, understanding the triggers, effective preventative and corrective actions and an effective and expedient resolution of such compliance issues will assist a manufacturer of product in preventing expensive remediation of compliance issues, delays to product launch, impact on current commercially available product, overall business reputation, product recall, Fines, loss of impacted Product, loss of business licensure andor prosecution by the FDA. Learning Objectives: Understanding the various implications of not adhering to the rules and regulations of the specific requirements guiding each product types and observed mistakes made by some manufacturers of products that led to the closure of several manufacturing site through an FDA injunction and further bankruptcy of a cGMP product manufacturer will be discussed. This will help in preventing a similar mistake or further detrimental actions from happening or progressing into even more difficult ones. The difficulties and cost associated with remediating an FDA’s Consent decree is very high and most manufacturers of a cGMP drug product have found it very difficult to come out of a consent decree due to the difficulties associated with remediation. Preventing the initiation and progression of compliance related issues and then instituting an appropriate way to address these issues effectively and expeditiously before they become impacting will be discussed. This seminar enhance the attendees’ knowledge as follows: Seminar Fee Includes: Lunch AM-PM TeaCoffee Seminar Material USB with seminar presentation Hard copy of presentation Attendance Certificate $100 Gift Cert for next seminar A description of what constitutes an FDA’s Form 483 Compliance Findings, Warning Letter or Consent Decree. The progression and severity of the various FDA compliance findings, triggers of the various progression of the compliance related disciplinary issues and criticality of each type. Discuss what companies are doing “Right” and “Wrong” when they have compliance related findings and letters such as FDAs form 483 Findings, Warning Letter or Consent Decree. Discuss the reasons why some companies with recurrent unresolved FDA’s Form 483 findings end up with further progressive compliance issues such as a subsequent FDA’s Warning Letter andor a Consent decree. Effective Steps in resolving FDA’s Form 483 Findings, Warning Letter and Consent Decree. The importance of expediting a company’s response to each type of compliance citation from by FDA. Discuss the entire process of Consent Decree and various scenarios and players in the process through remediation. Discuss several damaging effects arising from unresolved and difficult compliance related issues such as FDA’s Form 483 Compliance Findings, FDA’s Warning Letter and Consent Decree. The cost and other impact associated with resolving compliance Remediation Costs. The overall impact on manufactured products, regulatory filings, employees, product filing, and the overall business and its reputation. The most effective ways in addressing, handling and resolving or remediating compliance issues associated with FDA 483, Warning Letter and Consent Decree issues. Discuss several case studies of companies with progressive compliance issues that ended up in Consent Decree.
Topic Covered: Engineering Management , Manufacturing ,
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