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International Conference on Computer Technologies and Applications in Food and Agriculture

Konya  Turkey - 20th Jun 2019

The main theme of the conference is to address the challenges in foods and agriculture by facilitating leading scientists, engineers, and managers to exchange ideas, share latest developments and current technologies, and identify future trends.
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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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Canadian International Conference on Humanities & Social Sciences 2019

Toronto  Canada - 13th Jul 2019

Canadian International Conference on Humanities & Social Sciences 2019 serves as an international forum for the exchange of knowledge and experiences on key human development issues, contributing towards promoting social empowerment at a national, regional and global level.
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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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2nd International Conference on Interdisciplinary Practices in Management and Social Science IMSS

Osaka  Japan - 29th Jun 2019

The conference welcomes empirical research as well as theoreticalconceptual research papers having potential for field applications and in-depth literature reviews. Broadly defined, but not limited to, tracks of the conference are:
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2019 3rd International Conference on Natural Language Processing and Information Retrieval NLPIR 2019

Tokushima  Japan - 28th Jun 2019

After several rough review processes, accepted papers in NLPIR 2019 will be published in the International Conference Proceedings Series by ACM ISBN: 978-1-4503-6279-5, which will be archived in the ACM Digital Library, and indexed by Ei Compendex and Scopus.
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IASTEM - 632nd International Conference on Civil and Architectural Engineering ICCAE

Osaka  Japan - 27th Jun 2019

IASTEM - 632nd International Conference on Civil and Architectural Engineering ICCAE will be held on 27th - 28th June, 2019 at Osaka, Japan . 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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International Conference on Plastic Engineering & Polymer Science

Tokyo, Japan  Japan - 25th Jun 2019

International Conference on Plastic Engineering & Polymer Science is scheduled on June 25-26, 2019 in Tokyo, Japan. This conference builds efficient keynote presentations, Oral Talks, Poster Presentations and performances. The Plastic Engineering Conference establish a platform to share and gain knowledge by concentrate on the topics of Biopolymers, Bioplastics, Biomaterials, Polymer Science, Tissue engineering and regenerative medicine, Biodegradable polymers, composite polymer nanotechnology.
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2nd International Conference on Business Sustainability, Human Resource Development and Social Responsibility

Tokyo  Japan - 22nd Jun 2019

Tokyo Academy of Research & Innovation is aimed to provide a platform for Students, Professors, Researchers and professionals to exchange their research findings and developmental activities with local Japanese as well as international scholarly community. This platform will provide opportunities for the scholars to exchange new ideas and their experiences to establish research relations for future collaborations internationally.
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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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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: Management , Engineering , Management , Manufacturing ,
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