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NATIONAL CONFERENCE ON MAKE IN INDIA – MANAGEMENT’S ROLE & PERSPECTIVE

Indore  India - 25th Feb 2017

“Make in India” is the governments flagship campaign planned to boost the domestic manufacturing industry and attract foreign investors to invest into the Indian economy. The campaign was launched in September 2014 with an intention of reviving manufacturing businesses and emphasizing key sectors in India. To implement this program effectively, various initiatives have been taken so far. Now the issue is that, whether these initiatives are appropriate and sufficient enough to achieve the ‘growth’ objectives? What further initiatives can be taken? To address this issue, researches and deliberations are required.
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2017 4th International Conference on Advances in Business and Economics ICABE 2017

Chiang Mai  Thailand - 21st Apr 2017

Publication: 1. International Journal of Trade, Economics and Finance IJTEF, ISSN: 2010023X, DOI: 10.18178IJTEF as one volume, and will be included in Engineering & Technology Digital Library, ProQuest, Crossref, Electronic Journals Library, EBSCO, and Ulrichs Periodicals Directory. 2. International Proceedings of Economics Development and Research IPEDR, ISSN: 20104626, DOI: 10.7763IPEDR as one volume, and will be included in CNKI, WorldCat, Google Scholar, Ulrichs Periodicals Directory, Crossref, and Engineering & Technology Digital Library.
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International

Ghaziabad  India - 03rd Feb 2017

This two days International Conference aims to provide an open platform to researchers, academicians, executives from corporate and others to discuss at various ideas and suggestions to implement Egovernance strategies in a time bound and efficacious manner to reform government processes and enable transparency and efficiency in government
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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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Institute of Horticulture technology

Greater Noida  India - 09th Feb 2017

Institute of Horticulture Technology IHT is organizing ‘Horti India 2017’ on 9th and 10th February, 2017 at Horticulture Technology Park, Greater Noida NCR. ‘Horti India 2017’ is a Workshop cum Exhibition event focused on “Conventional and Alternative Horticultural Production Systems”. The event is being coorganized by Ministry of Agriculture and Farmers Welfare, Government of India.
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10th International Conference on IT in Asia CITA 2017

Kuching  Malaysia - 23rd May 2017

The 10th International Conference on Information Technology in Asia CITA17 is a premier international conference dedicated to address the advances in Information Technology, which over the years has become a leading interdisciplinary and multidisciplinary forum to bring academia and industry together in exchanging and sharing their most recent innovations, trends, challenges and adopted solutions. CITA17 will be held on 23rd – 24th May 2017, with the proposed theme of “Technology Transforming Lives”, emphasising on technologies that are making a difference in the global communities in improving their livelihoods.
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Inspired 2017 LONDON 26Jan17 An evening like no other. Unmissable!

One Moorgate Place LONDON  United Kingdom - 26th Jan 2017

INSPIRED SEMINAR 26 Jan 2017 , Outstanding 2 hour self development experience! Be motivated and focused in 2017, go for that job, get that relationship, achieve that fitness level, have confidence, Time: 7:00 pm to 9:00 pm
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International Conference on Statistics & Applied Mathematics ICSAM

Hong Kong  Hong Kong - 05th Feb 2017

International Conference on Statistics & Applied Mathematics ICSAM is an important event for researchers, academicians, mathematicians and Practitioners across the globe to participate and share their experience with experts of those fields. You have an awesome opportunity to join the world of scholars and became part of this conference by presenting your effort in the multiple disciplines regarding Statistics & Mathematics. This conference will provide an opportunity to exchange new ideas, its application prospects, and prospect to establish business or research relations and to find global partners for future collaboration.
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International Conference on Social Science, Economics & Education IC2S2E 2017

Bali  Indonesia - 29th Jan 2017

Welcome to the official website of 2017 International Conference on Social Science, Economics & Education IC2S2E 2017. The 2017 International Conference on Social Science, Economics & Education IC2S2E 2017 is to be held at Bali, Indonesia on 29th January, 2017. The main objective of IC2S2E is to provide a platform for researchers, academicians, practitioners, as well as industrial professionals from all over the world to present their research results and development activities in the fields of Social Science, Economics & Education. This symposium provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration.
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International Conference on Agricultural, Biological, Environmental & Plant Science ICABEPS2017

Bangkok  Thailand - 22nd Jan 2017

The idea of International Conference on Agricultural, Biological, Environmental & Plant Science ICABEPS2017 scheduled on 22nd January, 2017 at Bangkok Thailand is for the researchers, scientists, scholars, engineers, students and practitioners from all around the world to present and share ongoing research activities. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration. The conference will bring together leading academic scientists, researchers and scholars in the domain of interest from around the world.
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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

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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