Events
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The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic. How to Setup the Software. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar Start: 04/17/2012 9:03 am
End: 08/14/2012 9:03 am
Allan Gonsher and Kids Inc are pleased to a offer a series of Play Therapy Webinars. If your work with children, or want to work with children, these are workshops that you can not afford to miss. Each webinar workshop offers one hour of continuing education credit. Start: 08/14/2012 10:00 am
Overview: The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. The presentation will explain both methodologies and will show ways how these tools can be used to complement each other. Additionally the differences and limitations of both methods will be illustrated and the appropriateness during the different product development phases will be discussed. Areas Covered in the Session: Who Will Benefit: Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/14/2012 10:00 am
Overview: New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) beginning July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents is being written, which will replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU. The legal framework for pharmacovigilance on Medicinal Products for Human Use has now been updated, through an amended EU Regulation (No 1235/2010) and Directive (2010/84/EC). Why should you attend: This webinar is focused on understanding the new requirements for Good Pharmacovigilance Practices that will begin to become effective in the European Union beginning July 2012. The New Guidance on Good Pharmacovigilance Practices (GVP) has been updated by Module, of which the first seven Modules have been disclosed for public consultation. This Course will describe the Regulatory Updates, Guidance Updates and thoughts on how some Member States’ Competent Authorities will proceed with implementation. These regulatory changes will also impact the EU Clinical Trial Directive and expectations of sponsors in the protection of patients and public health, before, during and after a clinical study. Areas Covered in the Session: Detailed Agenda of the Session: Who Will Benefit: For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/14/2012 10:00 am
End: 08/14/2012 11:00 am
This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers. Why Should You Attend: Biomarkers have long been advocated by the FDA as a way of making development more efficient. However, detailed guidances are only now being issued. Over the last eighteen months the FDA has explained its current thinking on biomarkers in a series of final and draft guidances. Though not formally labeled as a series by the Agency, it is useful to consider a number of recent guidances as a group. This session will cover the emerging regulatory aspects for all classes of biomarkers: biomarkers of (1) efficacy, (2) toxicity, (3) dose-selection, & (4) patient-selection. The utility of each of these four classes of biomarkers varies according to the degree of validation, the business model of the company using them, and the terms under which regulatory approval is sought. Areas Covered in the Seminar:
Event Details: Date: August 14, 2012 Start: 08/14/2012 11:00 am
Manufacturing products for electronics, semiconductor and high-tech companies has become much more complex in recent years. In order to increase operational efficiency, companies need to drive down costs and reduce cycle times while sustaining or increasing quality which is critical to achieve success. Managing suppliers in various geographical regions based on their commercial risk, performance capabilities, strategic development and corporate vision requires central harmonized and standardized processes with visibility to management. Implementing an enterprise quality management system will allow companies to optimize quality, ensure compliance and reduce operational costs and risks. Flexible and configurable EQMS software allows enterprises to adapt to company-specific business processes, enabling users to define, track, manage and report on the core activities and processes vital to their success. TrackWise by Sparta Systems is a highly configurable software solution for corrective action and preventive action (CAPA), audit management, change control, compliance tracking, and much more. | ||
