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International Conference on Pharmaceutical and Biomedical Engineering

Taipei  Taiwan - 12th Jun 2017

Conference Series LLC is a renowned organization that organizes highly notable conferences throughout the globe. Currently we are bringing forth “International Conference on Pharmaceutical and Biomedical Engineering” Pharma Engineering 2017 scheduled to be held during June 1213, 2017 at Taipei, Taiwan. The conference invites all the participants across the globe to attend and share their insights and convey recent developments in the field of Pharmaceutical and Biomedical Engineering. Conference Theme: “Recent Innovations in Pharmaceutical and Biomedical Engineering”. Scientific Sessions: • Pharmaceutical Engineering • Drug Engineering • Pharmaceutical Technology • Pharmaceutical Analysis • Process Engineering • Medical Devices and Imaging • Biomedical Engineering • Biomechanics • Cell & Tissue Engineering • Bioinstrumentation and Bio imaging • Biomaterials • Genetic Engineering • Regulatory Compliance Who should attend??? With members from around the world focused on learning about Pharmaceutical and Biomedical Engineering and the most recent techniques, developments, and the newest s in this field; Target audience expected for this conference include Pharmaceutical Industries, Biomedical Engineering research institutes, Pharmaceutical Manufacturing Companies, Pharmaceutical Faculty, Biomedical Engineering Faculty, Pharmaceutical and Biomedical Engineering Associations and Societies, Pharmaceutical Researchers, Pharmaceutical & Biomedical students, scientists, Business Entrepreneurs, Consultancies offering Pharmaceutical & Biomedical courses and many more. To know more visit: http:engineering.pharmaceuticalconferences.com
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10th AsiaPacific Pharma Congress

Singapore City  Singapore - 08th May 2017

Conference Series LLC is a renowned organization that organizes highly notable pharmaceutical healthcare conferences throughout the globe. Conference Series LLC invites participants from all over the world to attend “10th AsiaPacific Pharma Congress” during May 0810, 2017 in Singapore.
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IIER 25th International Conference on Law and Political ScienceICLPS

Ottawa  Canada - 24th Dec 2016

2016 IIER 25th International Conference on Law and Political ScienceICLPS will be held in Ottawa, Canada during 24th25th December, 2016, as the Conference of ICLPS2016. ICLPS 2016 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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TechnoareteInternational Conference on Nanotechnology and BiosensorsICNB 2016

Ottawa  Canada - 24th Dec 2016

Our main objective is to promote scientific and educational activities towards the advancement of common mans life by improving the theory and practice of various disciplines and sectors of Life Science and Biological Engineering.
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CAASR Third International Conference on Advanced Theoretical Computer Applications CAASR3rd ICATCA17

Dubai  United Arab Emirates - 25th Jan 2017

The programming is so powerful to bring the whole world in to the small mechanical dimension. The programs are written based on the logics and features to give an output that satisfies the needs of billions of people around the globe especially in communication. There are lot of theoretical framework evolves on day to day basis to indentify and meet out the needs of the customers.
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10th Annual Focus Event on Registrant Regulation Conduct & Compliance

Toronto  Canada - 02nd May 2017

The 10th Annual Focus Event on Registrant Regulation Conduct & Compliance is Canada’s top event to help you achieve compliance excellence. Take back to your office key s, strategies and guidelines to direct your company. Develop a robust compliance program that will greatly reduce your legal risks with help from a Q&A with top regulators. Help your firm make the best of digital platforms while complying with regulations. Over 2 days, join regulators, compliance executives, industry stakeholders ultimate and legalexperts for networking, attending specialized tracks, participating in interactive sessions and learning from engaging speaker presentations. Contribute and learn from crossindustry dialogues and source insights to perfect your firm’s compliance culture.
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TORONTO2017 AESATEMA Int. Conferene Toronto, CANADA: July 10 14, 2017

Toronto  Canada - 10th Jul 2017

On "Advances and Trends in Engineering Materials and their Applications".
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22nd WORLD CONGRESS ON HEART DISEASE

Vancouver  Canada - 14th Jul 2017

The Congress will provide the opportunity for a comprehensive overview of the latest research developments in cardiovascular medicine, primarily in the areas of Molecular and Cellular Cardiology, Genetics of Heart Disease, Cardiac Imaging, Coronary Artery Disease, Peripheral Arterial Disease, Interventional Cardiology, Lipoprotein Disorders, Hypertension, Diabetes Mellitus, Heart Failure, Valvular Heart Disease, Diseases of the Aorta, Cardiac Arrhythmias and Electrophysiology, Antiarrhythmic Devices, Sudden Cardiac Death, Pediatric Cardiology, Congenital Heart Disease, Cardiac Surgery, Heart Transplantation, Mechanical Circulatory Support and Measurement of Outcome and Quality of Cardiovascular Care. Plans for this CME meeting are progressing extremely well, and as of now over 150 of the most distinguished cardiologists and scientists have agreed to join the faculty participating in this Congress. Papers will be presented in the form of plenary sessions, symposia and posters, and will include superb scientific material originating from numerous laboratories around the globe.
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International Conference of Theoretical and Applied Nanoscience and Nanotechnology TANN17

Toronto  Canada - 24th 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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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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