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2017 4th International Conference on Mechanical, Materials and Manufacturing ICMMM 2017

Atlanta  United States of America - 25th Oct 2017

Publication: All accepted papers of ICMMM 2017 will be published in published into IOP Conference Series: Materials Science and Engineering Online ISSN: 1757899X; Print ISSN: 17578981 which submitted for EI Compendex, Scopus, Thomson Reuters WoS, Inspec index, et al.
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2nd International Conference on Psoriasis, Psoriatic Arthritis & Skin Infections

Chicago  United States of America - 16th Oct 2017

On behalf of the Conference series LLC it is our great pleasure to cordially invite you to participate to PSORIASIS 2017 2nd International Conference on Psoriasis, Psoriatic Arthritis & Skin Infections to be held on Oct 1617, 2017, New York, USA.
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The 14th IEEE International Conference on Advanced and Trusted Computing

San Francisco  United States of America - 04th Aug 2017

IEEE ATC 2017 will include a highly selective program of technical papers, accompanied by workshops, panel discussions, and keynote speeches. It will offer a forum for researchers to exchange ideas and experiences related to Advanced and Trusted Computing.
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ACTheals 2017 International Conference

IL 60173  United States of America - 21st Sep 2017

Theme for this years conference is "Building Healing Communities in Christ". Details to be announced in early spring of 2017.
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Seventh International Conference on Health, Wellness & Society University of Denver

Denver  United States of America - 05th Oct 2017

Health, Wellness & Society Kledge Community: a conference and journal founded in 2011, exploring the intersections of human physiology and the conditions of social le.
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Annual World Congress on Biomarkers & Clinical Research

Atlanta  United States of America - 27th Nov 2017

PULSUS brings in a new spin on conferences by presenting the latest scientific improvements in Biomarkers and its clinical researches. Listen to motivating keynotes from thought leaders, pioneers across the globe. Atlanta is all set for an amazing event as PULSUS proudly presents the “Annual World Congress on Biomarkers & Clinical Research” on November 2728, 2017. PULSUS cordially welcome researchers, academicians, students and business professionals in the field of BIOMARKERS from around the world to participate in the upcoming BIOMARKERS CONGRESS 2017. The meeting for this year will revolve around the theme “Explore the latest Biomarkers development in health and clinical research” thus relaying the most cutting edge findings in the field of Biomarkers Research.
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State and Society in South Asia: Historical Perspective

Peshawar   Pakistan - 09th Oct 2017

We request abstracts on variety of themes of South Asian society and State relationship, dferent religions and emergence of cultssect in these religions; rise of guilds, economies, development of branches of kledge, historical transition from ancient to modern times and many more.
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International Conference of Theoretical and Applied Nanoscience and Nanotechnology TANN17

Toronto  Canada - 23rd Aug 2017

The International Conference of Theoretical and Applied Nanoscience and Nanotechnology TANN17 aims to become the leading annual conference in fields related to nanoscience and nanotechnology. The goal of TANN17 is to gather scholars from all over the world to present advances in the fields of nanoscience and nanotechnology and to foster an environment conducive to exchanging ideas and information. This conference will also provide an ideal environment to develop new collaborations and meet experts on the fundamentals, applications, and products of the mentioned fields.
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OTTAWA2017 AESATEMA Int. Conference Ottawa, CANADA: October 16 20, 2017

Ottawa  Canada - 16th Oct 2017

On "Advances and Trends in Engineering Materials and their Applications".
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9th International Conference On Bioinformatics Paris,France

Paris  France - 23rd Oct 2017

9th International Conference on Bioinformatics Paris, France Dates: October 2324, 2017 Venue: Paris, France On behalf of the Organizing Committee Members, we would like to invite everyone interested in the field of Bioinformatics to the 9th International Conference on Bioinformatics which will explore the latest research on Bioinformatics through diverse scientific topics. The event is scheduled during October 2324, 2017 at Paris, France. The conference revolves around the theme Exploring the latest innovations in Bioinformatics. The conference will gather grand expertise at the global platform to feature the most innovations to fulfill the needs of bioinformatics resources & technologies for the future research. Conference Website: http:bioinformatics.conferenceseries.com Conference Highlights: • Bioinformatics And Computational Biology • Systems Biology In Bioinformatics • Emerging Trends In Proteomics • Emerging Trends In Genomics • Health Informatics In Bioinformatics • Structural Bioinformatics • Evolutionary Bioinformatics • Biostatistics An Approach To Bioinformatics • Bioinformatics Algorithms & Databases • Bioinformatics Tools And Software • Immunology And Drug Discovery • Perspectives Of Clinical Informatics • Epigenetics • Clinical Case Reports For abstract submission, please find the link: http:bioinformatics.conferenceseries.comabstractsubmission.php For more queries, mail us at: bioinformaticscongress@biochemconferences.org
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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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