Education

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Course "The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lie in a lack of a suitable agreement delineating roles, responsibilities…

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Premier Publishing s.r.o. (Austria-Czech Republic) invites you to participate in the III International Conference on Education and Applied Psychology, which will be held in Vienna on April 15, 2018. The conference will be conducted in distance way without necessity of personal presence. We invite students and postgraduate students, postdoctoral students, employees of educational institutions, without regard to the country of residence, to participation in the conference. Articles for the conference proceedings are accepted till April 14, 2018 inclusive. Working languages: English, German, Russian, Ukrainian. Example of output data of an article: Mark, Smith. New approaches to applied psychology // Proceedings…

Overview: Why DMFs are important to you and your company , and How DMFs fit into FDA's regulatory processes for review of drug and biologic applications. Areas Covered in the Session: Why DMFs are important to you and your company How DMFs fit into FDA's regulatory processes for review of drug and biologic applications Why, more than ever, you may need DMFs to maintain current supplier agreements as well as to develop new business relationships What not to include Who Will Benefit: Manufacturing Regulatory Affairs Project Managers Global Supply Chain Research and Development Quality Assurance & Control Speaker Profile: Robert…

Course "Preparing the Marketing Authorization Application in the EU, with a focus on the product information" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In this seminar, we will look into all elements of the MAA dossier, in particular module 1, and within this module the Product Information. In addition, the various meetings with the Health Authorities in the centralized procedure will be discussed. Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration…

Overview: This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. Why should you Attend: We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test. The post test participant inquiry is critical to validation success. we will describe how to do this. Areas Covered in the Session: Required number of Participants Test Procedure Qualitative Success Criteria Choice of Tasks to Validate Post test Participant Inquiry Who Will Benefit: Engineer Engineering Manager Regulatory Personnel QA Speaker Profile:…

Hear from two inspirational keynote speakers and attend niche streams (many of which hosted by ICA Fellows) on topics relevant to you and your role including technology as an enabler, developing a compliance culture, managing change, doing business with high-risk jurisdictions, GDPR and much more. We are looking forward to welcoming our members and the wider compliance community to a day packed full of practical insight. This event is part of The Big Compliance Conversation, our new worldwide initiative designed to get the global compliance community talking about the key issues of today and tomorrow. The first event as part…

Hear from two inspirational keynote speakers and attend niche streams (many of which hosted by ICA Fellows) on topics relevant to you and your role including technology as an enabler, developing a compliance culture, managing change, doing business with high-risk jurisdictions, GDPR and much more. We are looking forward to welcoming our members and the wider compliance community to a day packed full of practical insight. This event is part of The Big Compliance Conversation, our new worldwide initiative designed to get the global compliance community talking about the key issues of today and tomorrow. The first event as part…

Overview: Organizations of all types and sizes continue to struggle needlessly with HIPAA Compliance. For example, HIPAA Risk Analysis - Risk Management is the basis of the HIPAA Compliance Program of every Covered Entity and Business Associate. But mandatory HIPAA Compliance Audits conducted by the Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services (HHS), found 94% of Covered Entities failed the Risk Management Audit and 87% failed the Risk Analysis Audit. And every audited Covered Entity knew well in advance that it was on the short list to be…

Product Format: Live Webinar Presenter: Dr. Sue Ohrablo, Ed. D. Conference Date: Thursday, April 19, 2018 Aired Time: 1:00 pm ET | 12:00 pm CT | 11:00 am MT | 10:00 am PT Length: 60 minutes Price: $199.00 With declining enrollments, educational institutions are increasingly relying on advisors to engage and retain students. Some schools evaluate advisors based on the number of students they contact, the academic success of their students, and the percentage of students retained. However, many advisors balk at being held accountable for factors beyond their control. So how do you engage and empower advisors to have…

The QS Connect MBA Fair (Networking Event) in Singapore is an evening of scheduled MBA admissions meetings. This is a unique MBA evening which allows you to connect with MBA admissions directors and alumni from local Singaporean programs as well as North American, European and Asian programs to help you discover the best business school for your profile. Our MBA consultants will be in touch to discuss your resume, personal experience and career goals and learn more about the kind of program you would like to attend. We will then match your profile with participating schools and schedule a series…

The Communication Institute of Greece (COMinG) in collaboration with the University of Barcelona, is glad to propose the Workshop « LEGO® Serious Play® method: Agile Learning in Superior Education and LifeLong Learning» When (?) date (?): Tuesday 24 April 2018, When (?) time (?): 17:00-19:00 (time could be modified before the conference) Where (?): The Stanley Hotel, 1 Odisseos str, Karaiskaki Square, Athens, Greece Lego Serious Play is one of the best methodologies and one of the most innovative for facilitating thought, communication and problem solving; oriented to improve the performance of people, teams and organizations. This workshop was selected…

SPE Workshop will cover one of the most important innovations of the XXI century in the energy sector - shale oil and gas resources development. The first time workshop in Russia and Capsian region will cover hard-to-recover reserves and the first time SPE workshop will take place in Belarus. The programme committee chaired by the distinguished experts, Mars Khsasnov, Gazpromneft STC, and Alexander Lyakhov, Belorusneft invites you to join the industry specialists from NOCs and IOCs. One of the most important innovations of the XXI century in the energy sector is shale oil and gas resources development, said the world…

Course "Industrial Technical Trainer Certification" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Each training day consists of eight full hours of instruction and skill practice. Trainee trainers must demonstrate competence at the end of the seminar by developing and preparing a simple training session utilizing all of the skills mastered. Trainees are evaluated and certified as technical trainers at the completion of the program when all performance measures have been met. Day one of the workshop will build the foundation for effective adult learning particularly in…

"Some of the technology projects that were experimental when we launched them several years ago are now an integral part of how faculty teach and students learn at Wharton. I'm excited for this opportunity to highlight what we've learned along the way, and I look forward to this opportunity to spend face-to-face time with my colleagues at business schools across the region," shared Dan Alig. "Opportunities like these are exactly why I joined the BusinessCAS team - to bring the right people to the table so that we can guide GME forward," shared Bob Alig, Liaison's strategic consultant for BusinessCAS.…

The idea of 9th International Conference on Studies in Education, Law, Economics and Interdisciplinary Studies (ELEIS-18) scheduled on April 27-28, 2018 Bangkok (Thailand) is for the researchers, social scientists, scholars, engineers and parctitioners 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. All full paper submissions will be peer reviewed and evaluated based on originality, technical and/or research content/depth, correctness, relevance to conference, contributions, and readability.…

The journal is registered and published in Austria. Articles on education, pedagogy and psychology are published in the journal. Journal is published in English, German and Russian. Example of output data of an article – Mark, Smith. School education in Western Europe countries // The European Journal of Education and Applied Psychology, Premier Publishing s.r.o. Vienna. 4, 2017. - Pp. 112-117. Periodicity: 4 issues per year. Articles are accepted till the 30th day of the months: Till the 28th of January Till the 30th of April Till the 30th of July Till the 30th of October The journal is intended…

11th International Conference on Business, Education, Humanities and Social Sciences Studies (BEHSSS-18-Istanbul) scheduled on May 1-2, 2018 at Istanbul (Turkey) is for the engineers, practitioners, scientists, researchers, scholars, and students from all around the world and it also includes the industry people to present ongoing research activities, and hence to foster research relations between Academia and industry. The conference is sponsored by Eminent Association of Pioneers (EAP). This conference provides opportunities for the delegates to share new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration. All the…

Overview: In this webinar would apply to computerized systems that create source documents (electronic records) that satisfy the requirements in 21 CFR 312.62(b) and 812. Areas Covered in the Session: What are source documents and why are they important? (FDA and ICH GCP E6 Guideline) What are required characteristics for source documents? What is 21 CFR Part 11? How can you apply 21 CFR 11 and ICH E6 to source documents? How EMR Data is used in Clinical investigations How to plan electronic source document deficiencies Who Will Benefit:Investigators Clinical Research Coordinators Device and Drug Study Clinical Research Associates Clinical…