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 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: 08/08/2012 10:00 am
End: 08/08/2012 11:00 am
This Spreadsheet validation training explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained. Description: Spreadsheets are powerful business tools, and are increasingly used in manufacturing, tracking and quality systems - as well as in generating and interpreting business data. FDA requires spreadsheets to be validated per 21 CFR 210-211, Part 820 and to be compliant to 21 CFR Part 11 in some cases. Areas Covered in the seminar: - Review of current FDA posture towards spreadsheets. Start: 08/08/2012 10:00 am
Overview: Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s. Most Form 483 audits are amicably resolved, but a few lead to serious consequences for the audited parties, starting with Warning Letters and ending with heavy fines and jail time for a few. This webinar, will assist you in responding to a 483 or Warning Letter so the consequences of the findings do not escalate beyond the current status. Areas Covered in the Session: Who Will Benefit: Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years experience in the Lifesciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and teaches classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management. More recently, Ms. Bazigos was selected to co-author Computerized Systems In Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. Angela Bazigos has been accepted into the prestigious ranks of Stanford Who's Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/08/2012 10:00 am
End: 08/08/2012 11:00 am
The webinar presents this year’s 2012 IEEE Virtual Reality Conference Best Paper, which was awarded to Sebastian Ullrich and Torsten Kuhlen. Their paper describes a novel approach for haptic palpation interaction and presents the results of an extensive user study conducted with medical experts. Presented findings contribute to medical simulation and potentially facilitate improved education of surgical procedures, reduction of costs and most importantly increased patient safety. Date & Time - Wed, Aug 8, 2012 10:00 AM - 11:00 AM PDT Presenter - Sebastian Ullrich Moderator- Dante David About the IEEE Computer Society The IEEE Computer Society is the world’s leading computing membership organization and the trusted information and career-development source for a global workforce of technology leaders including: professors, researchers, software engineers, IT professionals, employers, and students. The unmatched source for technology information, inspiration, and collaboration, the IEEE Computer Society is the source that computing professionals trust to provide high-quality, state-of-the-art information on an on-demand basis. The Computer Society provides a wide range of forums for top minds to come together, including technical conferences, publications, and a comprehensive digital library online, unique training webinars, professional training - e-learning courses, and a Corporate Affiliate Program to help organizations increase their staff’s technical knowledge and expertise.To find out more about the community for technology leaders, visit http://www.computer.org. Start: 08/08/2012 10:00 am
Overview: Both the U.S. FDA and the EU's MDD require companies to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e.g., MS-Excel and MS-Word, or similar. How can these be verified and validated? Company quality data must be more "science based". What V&V (verification and validation) planning steps are expected under the CGMPs and other guidance documents for such apps software? How can these consistently be executed? Where does ISO 14971, ICH Q9, and similar risk management systems come in? This webinar will evaluate the climate that has resulted in this call for change, and flag areas for heightened compliance in V&V planning. It will focus on eliminating major systemic validation problems. It will assist the attendee to review their existing system in light of current and anticipated changes in regulatory thinking, and in approaches to implementing necessary changes, in a realistic, risk-based approach. Why should you attend: Pressure is increasing on the FDA to get tougher on industry. The FDA has responded. How does that impact companies' use of COTS (commercial off the shelf) office applications software, such as spreadsheets and word processing? Just how much is required / expected? How can this be addressed? What does "science-based" mean? What are current 483 and Warning Letters indicating, and what can we learn from these? What benefits beside regulatory compliance can be achieved for a company? Areas Covered in the Session: Who Will Benefit: John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. Price List: Phone: 800-447-9407 webinars@globalcompliancepanel.com Start: 08/08/2012 1:00 pm
Wednesday, August 8, 2012 at 1pm EDT Chris Bostock, Dean, Achievement First Amistad High School During the webinar, participants will: For more information or to register, visit www.kickboardforteachers.com. | ||
