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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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International Management Convention 2018

bhubaneswar  India - 12th Jan 2018

International Management Convention in collaboration with University of Wroclaw, Poland and Westcliff University, US
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International Conference on Mathematics and Computing ICMC 2018

Varanasi, India  India - 09th Jan 2018

The fourth International Conference on Mathematics and Computing ICMC 2018 will be held during January 0911, 2018 at Indian Institute of Technology BHU, Varanasi, India. ICMC 2018 is the premier forum for the presentation of new advances and research results in the fields of Cryptology, Security and applied Mathematics. The conference will bring together leading academic scientists, expert from industry, and researchers in the domain of interest from around the world. The conference will have preconference Tutorial presentations, Invited talks and Research paper presentations. The invited talks and tutorials will be delivered by renowned experts. The conference proceedings of ICMC 2018 will be published by Springer. Important Dates: • Paper submission deadline: August 15, 2017 • Acceptance Notification: October 30, 2017 • Camera Ready Submission: November 7, 2017 • Early Bird Registration: November 10, 2017
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Cambridge Summit 2018

Cambridge  United Kingdom - 04th Jan 2018

Cambridge Summit 2018 on “Advances in Science, Engineering and Technology” provides a platform for defining, introducing, and presenting utterly novel methodologies for responsibly addressing the pressing contemporary SET problems. At Cambridge Summit 2018, platform for defining, introducing, and presenting utterly novel methodologies for responsibly addressing the pressing contemporary SET problems.
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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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5th International Conference of Fluid Flow, Heat and Mass Transfer FFHMT18

Niagara Falls  Canada - 10th Jun 2018

The 5th International Conference of Fluid Flow, Heat and Mass Transfer FFHMT18 aims to become the leading annual conference in fields related to fluid flow and heat transfer. The goal of is to gather scholars from all over the world to present advances in the fields of transport phenomena 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. All accepted and presented papers will be published in the conference proceedings, under an ISBN reference in a USB drive. The online version of the proceedings will also be published under an ISSN reference and each paper in the proceedings will be assigned unique DOIs by CrossRef. Furthermore, selected papers from the conference will be submitted for possible publication in the following journals from Avestia Publishing publication fees may apply: Journal of Fluid Flow, Heat and Mass Transfer FFHMT is an acronym for Fluid Flow, Heat and Mass Transfer To view the website for the previous event in this conference series, please visit: www.2017.ffhmt.com
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ISER-320th International Conference on Advances in Business Management and Information Science ICABMIS

Ottawa  Canada - 27th Feb 2018

ISER-320th International Conference on Advances in Business Management and Information Science ICABMIS is a prestigious event organized with a motivation to provide an excellent international platform for the academicians, researchers, engineers, industrial participants and budding students around the world to SHARE their research findings with the global experts. ICABMIS 2018 will be held in Ottawa, Canada on 27th-28th February, 2018.
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THE IRES - 326TH INTERNATIONAL CONFERENCE ON FOOD AND AGRICULTURAL ENGINEERING ICFAE

Ottawa  Canada - 27th Jan 2018

The IRES - 326th International Conference on Food and Agricultural Engineering ICFAE aimed at presenting current research being carried out in that area and scheduled to be held on 27th-28th January, 2018 in Ottawa, Canada. The idea of the conference is for the scientists, scholars, engineers and students from the Universities all around the world and the industry to present ongoing research activities, and hence to foster research relations between the Universities and the industry.
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The IIER 225th International Conference on Law and Political ScienceICLPS

Toronto  Canada - 28th Dec 2017

2017 IIER 225th International Conference on Law and Political ScienceICLPS will be held in Toronto, Canada during 28th29th December, 2017 as the Conference of ICLPS2017. ICLPS 2017 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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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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