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ISERD – 112th International Conference on Environment and Natural Science ICENS

Pune  India - 25th Dec 2016

ISERD – 112th International Conference on Environment and Natural Science ICENS aimed at presenting current research being carried out in that area and scheduled to be held on 25th26th December,2016 in Pune, India. 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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ISER – 103rd International Conference on Science, Technology, Engineering and Management ICSTEM

San Diego  India - 21st Jan 2017

ISER – 103rd International Conference on Science, Technology, Engineering and Management ICSTEM 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.
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Kanyakumari  India - 19th May 2017

The aim of the conference is to provide a platform for scientists and academicians all over the world to promote, share and discuss various new issues and developments in dferent areas of Mechanical Engineering with interfaces in its interdisciplinary Developments
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International Conference on Knowledge Discovery and Computational Intelligence ICKDCI 2017

Chennai  India - 06th Apr 2017

The vision of ICKDCI 2017 is to foster communication among researchers and practitioners working on varied areas of Knowledge Discovery and Computational Intelligence. English is the official language of the conference. Prospective authors are invited to submit full and original research papers which are not submitted published under consideration elsewhere.
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International Conference on Emerging Trends in Materials and Manufacturing Engineering

Tiruchirappalli  India - 10th Mar 2017

Department of Metallurgical and Materials Engineering, National Institute of Technology Tiruchirappalli in association with Indian Institute of Metals, Trichy Chapter and Indian Welding Society, HQ Chapter, organizing the conference with an objective to bring experts and budding researchers together on a common platform to discuss and exchange ideas on recent developments, findings and progresses on wide areas related to materials and manufacturing engineering. This will provide opportunities to new researchers to explore new directions in their research through interaction with the leaders in the field. It also aims to impart sound knowledge and expertise in selected research field through key note lectures deliver by eminent speakers from India and abroad. Topics but not limited to: Extractive process metallurgy Mechanical behavior of materials Phase transformations Fatigue & Fracture Mechanics Severe Plastic Deformation Nanomaterials Ultrafine grained materials Ceramics High Entropy Alloys Surface engineering Tribology Thermoelectric Materials Metal Joining Metal forming Composite materials Biomaterials Materials Characterization Nondestructive testing Corrosion Heat Treatment Metal casting Powder metallurgy Synthesis of materials High Temperature Materials Process Modeling and Simulation Micromachining Metal cutting Unconventional manufacturing
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International Conference on Algorithms, Methodology, Models and Applications in Emerging Technologies

chennai  India - 16th Feb 2017

Call for papersDetails: IEEE Sponsored International Conference ICAMMAET2017 is happening between 1618 Feb, 2017 in Chennai, India. Last date to submit abstracts: 01 Dec, 2016. Head over to icamma.org for more details.
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IEEE International conference on ISMAC IoT in Social, Mobile, Analytics and Cloud

Palladam,Tirupur Dist.  India - 10th Feb 2017

IEEE International conference on ISMAC will provide an outstanding international forum for sharing knowledge and results in all future fields of Internet of Things in Social, Mobile, Analytics and Cloud. All submitted papers will be peerreviewed. Accepted papers will be published in IEEE Xplore and CFY conference proceedings
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International Industrial Trade Fair

Coimbatore  India - 01st Jun 2017

This muchawaited International Industrial Trade Fair INTEC 2017 IS brought to you by CODISSIA The Coimbatore District Small Industries Association, brings together the very best intechnological advancement. INTEC is a congregation of various Industries exhibiting their finest .
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ICSTS17 International Conference on Science & Technology for Society

Singapore  Singapore - 20th May 2017

ICSTS 2017 is an International forum which provides a stateoftheart platform to researchers of all streams. It is coming up with its 3rd International Congress On Science & Technology For Society With A theme:Conservation of Environment by Advanced Technologies through social Approaches for Sustainable Development in Singapore during May 22,23 & 24,2017.It is one of the leading Global conferences for presenting novel and fundamental advances in the fields of Science,Technology & Humanity.It will serves to foster communication amongst researchersand pracririoners working in a wide variety of scientific areas with a common interest in enriching Science for Humanity and related techniques. All Selected and Registered papers for the ICSTS 2017 will be published in Regular Peer Revied Abstracted Indexed Journal issue of May2017 in International Journal of Researches in Biosciences,Agriculture & Technology,IJRBAT and International Journal of Researches in Social Sciences & Information Studies,IJRSSIS.Above Journals user viperAntiPlagiarism Scanner Software for Plagiarism.Plagiarism in any form is not allowed & is a punishable offence Authors are kindly requested to submit full text papers including Results,Tables,Figures and Refernces.Full text papers will be accepted in.docx,doc file only by Electronic Submission System onlywww.vmsinda.org.Research articles submitted to the conference should meet criteria of guidlines for manuscript submission of Journals which are online mentioned in http:vmsindia.org. | Paper Page Limit | Regular Papers : 6 pages only, including all Figures,Tables,and References. Submission Method : Electronic Submission System available in www.vmsindia.org English is the official language of the conference.We welcome paper submission.Prospective authors are invited to submit full lenghtehich are NOT submittedpublishedunder consideration anywhere in other conferencesJournal abd should be in electronicWorld .doc& .docx format only.
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4th International Conference on Business Analytics and Intelligence ICBAI 2016

Bangalore  India - 19th Dec 2016

To create a platform and facilitate kledge sharing on advanced data analysis, business analytics, big data and business intelligence for distinguished academicians, practitioners and researchers from academia and industry.
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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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