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Systemic Conditions 2018

Toronto  Canada - 03rd Dec 2018

Allied academies welcome you to attend International Conference Systemic Conditions & Therapies during December 03-04, 2018 at Vancouver, Canada. We cordially invite all the participants interested in sharing their knowledge and research in the arena of study of organisms and their relationship with environment. Systemic means affecting the entire body, rather than a single organ or body part. For example, systemic disorders, such as high blood pressure, or systemic diseases, such as the flu, affect the entire body. An infection that is in the bloodstream is called a systemic infection. We anticipate more than 300 participants around the globe with thought provoking keynote lectures, oral and poster presentations. The attending delegates include Editorial Board Members of related journals. The scope of Systemic Conditions-2018 is to bring the advancements in the field of Medical science of all the relations of Human body, all organisms to all their Researchers
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4th 2018 Academy of Business and Emerging Markets ABEM Conference

Manila  Philippines - 01st Aug 2018

ABEM invites papers, abstracts, case studies and proposals for special sessions and doctoral students on the theme Innovation, Competition and Solution in the areas of: BUSINESS GOVERNMENT COMMUNITY ● Marketing ● Government Policy ● Agriculture ● Operations ● Fundraising ● Eco-tourism ● OnlineEducation ● E-Government ● Micro-Finance ● Human Resources ● International Trade ● Sustainability ● FinanceAccounting ● International Relations ● Rural Marketing ● Marketing Analytics ● Genetically Modified Food ● NonprofitCo-op ● Cross-cultural Issues ● Foreign Direct Investment ● Healthcaremedical ● Social Media Marketing ● Environment Management ● Bottom of the Pyramid ● Organizational Behavior ● Public Sector Management ● Informal Sector Economy ● StrategyEntrepreneurship ● Law, Patents & Inventions ● Nutrition and Community
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2018 2nd International Symposium on Intelligent Unmanned Systems and Artificial IntelligenceSIUSAI 2018

Las Vegas, USA  United States of America - 27th Aug 2018

2018 2nd International Symposium on Intelligent Unmanned Systems and Artificial IntelligenceSIUSAI 2018- August 27-29, 2018. |Las Vegas, USA|Website: http:www.siusai.org
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Systemic Condition 2018

Vancouver  Canada - 03rd Dec 2018

Conference Series LLC welcome you to attend International Conference Systemic Conditions & Therapies during December 03-04, 2018 at Vancouver, Canada. We cordially invite all the participants interested in sharing their knowledge and research in the arena of study of organisms and their relationship with environment. Systemic means affecting the entire body, rather than a single organ or body part. For example, systemic disorders, such as high blood pressure, or systemic diseases, such as the flu, affect the entire body. An infection that is in the bloodstream is called a systemic infection. We anticipate more than 300 participants around the globe with thought provoking keynote lectures, oral and poster presentations. The attending delegates include Editorial Board Members of related journals. The scope of Systemic Conditions-2018 is to bring the advancements in the field of Medical science of all the relations of Human body, all organisms to all their Researchers.
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18th International Conference on Biopsy & Bone Marrow Aspiration 2018

Toronto  Canada - 15th Oct 2018

On behalf of Allied Academies, we would like to officially invite you to attend and participate at the 18th International Conference on Biopsy & Bone Marrow Aspiration 2018 in Toronto, Canada a leading tourism destination in Canada. The purpose of this 2-day conference is to bring together high profiled researchers, scholars, eminent personalities and students from both academic and industrial fields throughout the world under a single roof. The conference will focus on the theme: “Invasive to Non-Invasive: Exploring Genetic Landscape of All Cancerous Lesions & Guide to Treatment”. This will explore the link between Tumors, Biopsy, Bone Marrow, Cancer treatment and drug discovery in the latest generation.
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Nutrition 2018

Vancouver, Canada  Canada - 19th Sep 2018

Conferenceseries LLC warmly welcomes all the participants and contributors from worldwide to attend the" 21st International Conference on Nutrition and Fitness Summit and Expo" during September 19-20, 2018 in Vancouver, Canada. Nutrition 2018 highlights the theme “Exploring the Novel trends of Nutrition to Provide a Better Health”. Which includes keynote presentations, plenary sessions, young researcher talks, poster presentations.
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International Conference on the Humanities and the Social Sciences ICHSS 2018

Peradeniya  Sri Lanka - 22nd Nov 2018

The faculty of Arts, University of Peradeniya is organizing the International Conference on the Humanities and the Social Sciences ICHSS for the 4th consecutive year and It is expected that the academics, researchers, governmental officers, professionals, administrators, policy makers, graduates and other interested persons to join the ICHSS 2018 to share their knowledge with scholars with international expertise in the fields of Humanities and Social Sciences. ICHSS 2018 will be an exciting and challenging international conference which provides a platform to discuss current social issues in the world and to introduce new research findings related to Humanities and Social Sciences. The conference will afford participants the opportunity to develop social networks among a group of international participants. The theme of the Conference this year is “Development, Diversity and Harmony through Knowledge and Innovation”. The Conference will include a multitude of research papers under a wide variety of themes such as: Languages and Literary Studies, Religious and Cultural Studies, Buddhist and Pali Studies, Economic Research, Arabic and Islamic Studies, Archaeology, History and Heritage Studies, Greek and Roman Studies, Political Science and Public Administration, Sociology and Social Anthropology, Philosophy: East and West, Psychology and Counselling, Geography and Environmental Studies, Art, Theater and Media, Library and Information Studies, Education and Pedagogy, Tamilology amongst others.
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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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2018 2nd International Conference on Functional Materials and Chemical EngineeringICFMCE 2018

Abu Dhabi  United Arab Emirates - 20th Nov 2018

★2018 2nd International Conference on Functional Materials and Chemical EngineeringICFMCE 2018 November 20-22,2018|Abu Dhabi,UAE|Website:http:www.icfmce.org ★Venue:Khalifa University, Abu Dhabi,UAE Khalifa University جامعة خليفة, also known as Khalifa University of Science, Technology & Rese
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ICETI 2018 International Conference on Environmental Technology and Innovations

Prague  Czech Republic - 21st Nov 2018

ICETI 2018 will provide a forum for presentation and discussion of scientific papers, covering a number of topics within environmental science and engineering. ICETI is organized in cooperation between the Faculty of Environmental Technologies, University of Chemistry and Technology, Prague, cluster WASTEN, Faculty of Environment and Labour Safety, Ton Duc Thang University, Université de Strasbourg - Icube and University od Natural Resources and Life Sciences, Vienna. This conference brings together engineers, scientists, researchers, students, managers and other professionals in order to address and discuss emerging environmental issues dealing with interactions of industrial development and environment. The success of this conference reflects the critical environmental topics that are discussed as well as the quality of the presented papers. All the papers which are selected for either oral or poster presentations undergo a review process.
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World Conference Alerts Conference

21 Apr 2016

22 Apr 2016

 

Sydney Seminar on Validation and Part 11 Compliance of Computer Systems and Data

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Event Serial - WLD10479
Website   http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900338SEMINAR
Contact Person - Event Manager
Event enquiries email address - support@globalcompliancepanel.com
Deadline for abstracts/proposals: 2016-04-19
Organized by: NetZealous LLC, DBA GlobalCompliancePanel View more Conference
Venue: sydney,  sydney,  Australia

About Event


Course "Validation and Part 11 Compliance of Computer Systems and Data” has been preapproved by RAPS as eligible for up to 12 credits towards a participants RAC recertication upon full completion. Overview: Analytical equipment should be qualied and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EUPICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualication, validation and electronic laboratory are records are on target of inspectors. The large numbers of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations. This 2day course provides the regulatory background and guides attendees through the complete equipment qualication, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures. The 2day course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fillin templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course. Additional Bonus Material for easy implementation: 70page primer Analytical Instrument Qualication and System Validation authored by Dr. Ludwig Huber 10 SOPs related to validation and qualication of analytical equipment and computer systems. change control, risk assessment, maintenance, security and integrity of electronic records Full Set of Qualication examples for an HPLC system Full set of Validation examples of a chromatographic Data System Why should you attend? Learn about the regulatory background and requirements for equipment qualication according to USP , computer system validation according to GAMP Guides Learn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11 Be able to explain the dference between equipment calibration, qualication and system validation Understand and Implement the new UK MHRA GMP Data Integrity Guideline Learn which equipmentsystems need to be qualied or validated Be able to allocate equipment and systems to USP and GAMP categories and to design and execute qualicationvalidation protocols accordingly Understand the logic and principles of instrument qualication and system validation from planning to report Be able to explain your companys qualication and validation strategies Understand how to archive raw data from hybrid systems: electronic vs. paper Be able to define and demonstrate Part 11 compliance functionality to auditors and inspectors Be able to develop inspection ready documentation during ongoing routine operation Learn how to avoid andor respond to FDA inspectional observations and warning letters Who will benefit: ITIS managers and System Administrators QA Managers and Personnel Laboratory Managers and Supervisors Analysts Validation Specialists Software Developers Regulatory Affairs Training Departments Documentation Departments Consultants Agenda: Day 1 Schedule Lecture 1: Requirements and approaches for Instrument Qualication and Computer System Validation • FDAEU, ICH and PICS requirements • Lessons from recent FDA warning letters • Understanding the terminology: qualication, calibration, verication, validation. • EUPICS GMP Annex 15: Validation and Qualication • USP Chapter for analytical instruments: current and proposed changes • Lessons from GAMP®5 and from the GAMP® guide: "A Risk based Approach to Laboratory Systems" • Planning for costeffective qualication and validation • Which systems require qualicationvalidation Lecture 2: Going through the equipment qualication phases • Develop a project plan from the master plan • Writing requirement specications • Documenting installation and installation qualication • Testing for initial operational qualication • System Suitability testing for performance qualication • Preparing and executing test protocols • Preparing inspection ready documentation • Maintenance, requalication and change control Lecture 3: Cost Effective Validation of Computer Systems: StepbyStep Part 1 • Selecting the right validation lecycle model • Going through examples of a complete computer system validation from beginning to end • Rrisk assessment for type and extend of validation • Defining user requirements based on risk • Vendor assessment and supplier agreements • Testing and documenting installation • Going through examples for OQ and PQ testing • Writing the validation report Lecture 4: Validation of Computer Systems Part II • Leveraging validation efforts of identical systems • Validation of existing equipment and computer systems • Preparing inspection ready validation documentation • Integrating the GAMP® guide with USP for integrated instrument and system validation • IT infrastructure qualication and validation of networked systems • Validation and use of cloud computing in FDAEU regulated environments • Recommendations for dferent cloud models and services • Validation of mobile apps Day 2 Schedule: Lecture 1: Validation and control of Excel spreadsheet applications • Designing spreadsheets for compliance • Validation approach for spreadsheet applications • When, what and how much to test? • Recommendations from GAMP®5 for testing native Excel functions • How to ensure spreadsheet and data integrity • Going through examples • Excel spreadsheet validation from beginning to the end: A case study that can be used by everybody Lecture 2: Maintaining the validated state of computer systems • Ongoing training of users and IT staff • System maintenance and data backup • Change control: Handling planned and unplanned changes, e.g., handling security patches • Periodic review vs. revalidation • Disaster recovery and business continuity • Retirement of computer systems and data migration Lecture 3: Introduction to FDA 21 CFR Part 11 and EUPICS Annex 11 • Objective, scope, current situation and future of Part11 • Requirements overview and spirit of the regulation • Requirements for electronic records • Requirements for electronic and digital signature • Additional requirements from the PICSEU Annex 11, from the UK MHRA and from the WHO GMP data integrity guidelines • FDAEU inspection and enforcement practices of electronic records: examples of recent FDA warning letters • User requirements for Part11Annex 11 based on risk • Upgrading old or purchasing new systems: compliance and business aspects • Six steps for implementation of Part11Annex 11 Lecture 4: Ensuring and documenting Integrity of Laboratory Rawdata and other Records • Definition of raw data: FDAEMA requirements • What to archive for hybrid systems: paper records or electronic records • The importance of electronic audit trail to document data integrity • Review of electronic audit trail: who, what, and how • How to ensure availability of electronic records throughout the entire retention period • Steps for validating security and integrity functions • Examples how to ensure and document data integrity and security • Preparing your company for data integrity audits Speaker: Dr. Ludwig Huber Chief Advisor Global FDA compliance, Labcompliance Dr. Ludwig Huber, Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualication in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLPGMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Hubers website www.ludwighuber.com Location: Sydney, Australia Date: April 21st & 22nd, 2016 and Time: 9:00 AM to 6:00 PM Venue: Hilton Sydney Address: 488 George Street, Sydney, Australia 2000 Price: Register and save $200. Early Bird Without Stay Price: $1,695.00 Seminar for One Delegate With Stay Includes Price: $2,095.00 Seminar for One Delegate Until March 10, Early Bird Price: $1,695.00 from March 11 to April 19, Regular Price: $1,895.00 Until March 10, Early Bird Price: $2,095.00 from March 11 to April 19, Regular Price: $2,295.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 18004479407 Fax: 3022886884 Email: support@globalcompliancepanel.com Website: http:www.globalcompliancepanel.com Registration Link http:www.globalcompliancepanel.comcontrolglobalseminars~product_id900338SEMINAR
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