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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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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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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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ICI2018 International Conference for Innovations in Cardiovascular Systems

David Intercontinental Hotel  Israel - 02nd Dec 2018

ICI Meeting 2018 – the premier International Conference for Innovations in Cardiovascular Systems Heart, Brain and Peripheral Vessels and High-Tech Life Science Industry. Time: 7:30 am to 5:30pm. Price: Early Bird Price: USD 500.0
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18th International Conference on Polymer Catalytic Chemistry and White Biotechnology

Vancouver  Canada - 22nd Apr 2019

Greetings from White Biotechnology 2019, Canada. It is our great honour to invite all the academicians and industrial researchers to be as a speakers or delegates at the upcoming 18th International Conference on Polymer Catalytic Chemistry and White Biotechnology scheduled during April 21-22, 2019 in Vancouver, Canada
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The IIER - 553rd International Conference on Recent Innovations in Engineering and Technology ICRIET

Toronto  Canada - 28th Dec 2018

2018 IIER 553rd International Conference on Recent Innovations in Engineering and Technology ICRIET will be held in Toronto, Canada during 28th - 29th December, 2018 as the Conference of ICRIET-2018. ICRIET 2018 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 Recent Innovations in Engineering and Technology. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Recent Innovations in Engineering and Technology related techniques.
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The IIER - 557th International Conference on Advances in Business Management and Information Technology ICABMIT

Toronto  Canada - 28th Dec 2018

2018 IIER 557th International Conference on Advances in Business Management and Information Technology ICABMIT will be held in Toronto, Canada during 28th - 29th December, 2018 as the Conference of ICABMIT-2018. ICABMIT 2018 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 Business Management and Information Technology. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Business Management and Information Technology related techniques.
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2019 Australian Pain Society 39th Annual Scientific Meeting

Broadbeach  Australia - 07th Apr 2019

In 2018 we were challenged to Collaborate. Disseminate. Educate. The year 2019 invites a different posture, as we gather to extend the gains of 2018 while reflecting on The IASP Year Against Pain in the Most Vulnerable. The Scientific Program Committee has curated a stellar cast of not-to-be-missed national and international speakers including: Professor Beth Darnall Department of Anesthesiology, Stanford University: prevention of post surgical pain, targeted psychological strategies, opiod reduction; Dr Nanna Finnerup Department of Clinical Medicine, Aarhus University, Denmark: pathophysiology and therapy of neuropathic pain; and Professor Tor Wager Cognitive and Affective Neuroscience laboratory, University of Colorado: neurophysiology of pain and emotion, affective learning, and brain-body communication.
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6TH INTERNATIONAL CONFERENCE ON “TRENDS IN MULTIDISCIPLINARY BUSINESS & ECONOMIC RESEARCH” TMBER-2019

Sydney  Australia - 23rd Mar 2019

We invite the scholars scientists engineers researchers practitioners students to join with us and share the new innovative trends in their respective field. This common platform is expected to provide the bases for joint venture among different fields to serve the society in a better way. INDIVIDUAL CALL FOR PAPERS FOR EACH TRACK: Business , Management and Economics Studies Health and Medicine Studies Engineering & Technology Studies Social Science & Humanities Physical Life and Applied Sciences Regional and Religious Studies Multidisciplinary and Interdisciplinary Studies
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The IIER - 551st International Conference on Social Science and Economics ICSSE

Melbourne  Australia - 24th Dec 2018

2018 IIER 551st International Conference on Social Science and Economics ICSSE will be held in Melbourne, Australia during 24th - 25th December, 2018 as the Conference of ICSSE-2018. ICSSE 2018 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 - 544th International Conference on Applied Physics and Mathematics ICAPM

Melbourne  Australia - 24th Dec 2018

2018 IIER 544th IIER International Conference on Applied Physics and Mathematics ICAPM will be held in Melbourne, Australia during 24th - 25th December, 2018 as the Conference of ICAPM -2018. ICAPM 2018 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 Applied Physics and Mathematics. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Applied Physics and Mathematics related techniques.
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7th International Conference of Networks and Communications NECO 2018

Sydney, Australia  Australia - 22nd Dec 2018

7thInternational Conference of Networks and Communications NECO 2018 looks for significant contributions to the Computer Networks & Communications for wired and wireless networks in theoretical and practical aspects. Original papers are invited on Computer Networks, Network Protocols and Wireless Networks, Data Communication Technologies, and Network Security. The goal of this Conference is to bring together researchers and practitioners from academia and industry to focus on advanced networking concepts and establishing new collaborations in these areas.
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2018 3rd International Conference on Mechanical Engineering and Robotics Research ICMERR 2018

Melbourne  Australia - 17th Dec 2018

For papers submitted to ICMERR 2018, we offer the publication as following: Publication in IJMERR. Submissions will be reviewed by the conference committees and IJMERR editorial board, and All accepted papers will be published in the International Journal of Mechanical Engineering and Robotics Research as a special issue, which will be indexed by Index Corpernicus, ProQuest, UDL, Google Scholar, Open J-Gate, Scopus since 2016, etc.
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2018 5th International Conference on Environmental Systems Research ICESR 2018

Brisbane  Australia - 06th Dec 2018

Paper Publishing: ICESR 2018 papers will be published in International Conference Proceedings. It is mandatory that at least one author registers and presents for every paper that is included in the conference proceedings. The Conference Proceedings which will be indexed by EI Compendex and submitted to be reviewed by SCOPUS.
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IASTEM - 510th International Conference on Civil and Architectural Engineering ICCAE

Sao Paulo  Brazil - 14th Dec 2018

IASTEM - 510th International Conference on Civil and Architectural Engineering ICCAE will be held on 14th - 15th December, 2018 at Sao Paulo , Brazil . 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- 513th International Conference on Environment and Natural Science ICENS

Sao Paulo  Brazil - 14th Dec 2018

IASTEM- 513th International Conference on Environment and Natural Science ICENS will be held on 14th - 15th December, 2018 at Sao Paulo , Brazil . 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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IASTEM- 510th International Conference on Mechanical and Aerospace Engineering ICMAE

Sao Paulo  Brazil - 14th Dec 2018

IASTEM- 510th International Conference on Mechanical and Aerospace Engineering ICMAE will be held on 14th - 15th December, 2018 at Sao Paulo , Brazil . ICMAE is to bring together innovative academics and industrial experts in the field of Mechanical and Aerospace Engineering to a common forum.
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The IIER - 541st International Conference on Science, Innovation and Management ICSIM

Toronto  Canada - 28th Dec 2018

2018 IIER 541st International Conference on Science, Innovation and Management ICSIM will be held in Toronto, Canada during 28th - 29th December, 2018, as the Conference of ICSIM-2018. ICSIM 2018 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 - 545th International Conferenceon Chemical and Biochemical EngineeringICCBE

Toronto  Canada - 28th Dec 2018

2018 IIER 545th International Conferenceon Chemical and Biochemical EngineeringICCBE will be held in Toronto, Canada during 28th - 29th December, 2018 as the Conference of ICCBE -2018. ICCBE 2018 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 Chemical and Biochemical Engineering. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving Chemical and Biochemical Engineering related techniques.
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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 Seria l -  WLD10479
Website  
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
Topic Covered: Management , Computer software and applications ,
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