Calendar of EventsSponsoring or hosting an event that our readers would like to attend?
Kentucky Association for Medical Instrumentation Held at Sts Mary and Elizabeth Hospital, Louisville, Ky. Please RSVP for the 5:15 pm meeting to the e-mail above.
University of Vermont Three credit university course or non-credit option available at lower cost.
Content includes:
• Healthcare technology management overview
o Medical devices, equipment and systems
o Information technology and telecommunications
o Blending of IT and medical technology for the electronic medical record
o Safety and security
• Technology planning
o Assessment
o Replacement
o Acquisition
• Life cycle management
o Safety
o Maintenance
o Asset
• Technical Services
o Clinical engineering
o Information systems
o Telecommunications
URL: http://its.uvm.edu/medtech/index.html
GlobalCompliancePanel Medical device companies have done some form of design risk management for many years, although with the introduction of ISO 14971, the techniques have evolved and improved. The area of Post-design Risk Management is new to the medical device world with the introduction of ISO 14971. Companies are attempting to interpret and apply these new requirements with mixed results. In addition are the changing requirements of regulatory bodies in the postmarket phase of the device lifecycle.
The North Carolina Biomedical Association The North Carolina Biomedical Association will now hold its Annual Symposium in September instead of December at the Embassy Suites in Concord, NC. Check the Web site to register.
North Central Biomedical Association - NCBA To be held at the Holiday Inn Minneapolis Northwest- Elk River in Minnesota. The conference includes classes and a vendor exhibit. Check the Web site for more details and to register.
ComplianceOnline This Quality System Regulation training we will review the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined.
ComplianceOnline In this Effective Standard Operating Procedure (SOP) training learn how to develop a comprehensive, consistent SOP. The critical elements of a SOP which is easier to understand follow and review by operating personnel.
GlobalCompliancePanel On July 8, 2010, the FDA announced to soon conduct a series of inspections related to 21 CFR Part 11. FDA made it very clear that the focus of the inspections will on most critical issues the industry had with Part 11 in the past. The best way to find out what the issues are is to look at recent FDA 483 form inspectional observations and warning letters related to computer system validation and Part 11 compliance. Just from 2007-2010, there have already been more than 30 such warning letters, some with disastrous consequences for inspected companies. This seminar will give an overview of FDA inspection findings and recommendations on how to avoid them.
ComplianceOnline In this webinar our expert trainer Jeff Kasoff will explain the best way to identify which employees can be the most effective auditors and how to train them.
ComplianceOnline This change control webinar will discuss the change control activities and documentation required to meet GMP requirements.
BET/MIT Club This event will cover customer service, rounding techniques, equipment demonstrations, DICOM/PACS/Networking, CompTia A+ Certification prep and a final hour long roundtable Q&A discussion. Instructors and leaders in the Biomedical community are coming together on Saturday September 11 from 10-4pm. This will be a warm-up to our First Annual TSTC Waco Biomed Fair coming early in 2011. Those interested are urged to contact Dr. Roger Bowles by email to inquire about participating in these events. Please RSVP on our Event on the Events Page on our Facebook Group. Hope to see you there!
Indiana Biomedical Society The meeting at St Vincent Hospital in Indianapolis will cover intra-aortic balloon pumps.
The 2010 VBA Annual Meeting "Leading the Way Into a New Decade; Full of New Challenges”
Visit the Web site to register for the Annual Meeting at the Wintergreen Resort.
GlobalCompliancePanel Acceptance activities should be easy for device manufacturers. As one of the most frequently cited sections, however, there are issues and problems in this area of the regulations. This webinar will help you understand what you should do. By analyzing recent Warning Letters, you can learn from the mistakes of others, and ensure your acceptance activities fully comply with both good practice and the regulatory requirements.
ComplianceOnline This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.
Note: Use this Promo Code(102924) to avail Discount of 10% on LIVE Purchase.
Prep Session for the Certified Patient Safety Officer Exam The International Board for Certification of Safety Managers (also known as the BCHCM), offers a prep session for the Certified Patient Safety Officer (CPSO) exam.
The CPSO exam focuses on topics such as culture, communication, patient safety goals, sound care practices, and coordination of patient safety-related initiatives. The exam assesses a candidate's comprehension and application of the key concepts necessary to lead, coordinate, develop, implement, or support patient safety programs.
GlobalCompliancePanel Do you like to keep up with current industry trends? Are you interested in the future of analytical method development and qualification? Are you curious to see how a QbD approach could also work for analytical methods? Would you like to see more robust methods resulting in fewer OOS results? If you answered yes to any of the above questions then this seminar is for you.
GlobalCompliancePanel In the medical device world, the US FDA has become more aggressive in enforcement of the regulations for manufacturers and others. The FDA has stated they will be quicker to issue Warning Letters to device companies, and evidence shows that is the case.
The presentation will show techniques that may be used with publically available information to follow FDA's current practices and predict how the manufacturer may act to avoid a Warning Letter.
ComplianceOnline This 510(k) webinar training will discuss how to do a meaningful result drive 510(k)/change analysis activity so as to satisfy FDA requirements.
GlobalCompliancePanel The U.S. FDA implemented Design Control requirements in 1996/97, and yet continues to find problems in the key design control document, the Design History File (DHF). Yet this drives the Device Master Record as well as providing major support for the EU MDD's Technical File / Design Dossier. What are the FDA expectations for the DHF under Design Control? What are the EU MDD / Notified Body's expectations for the complementary TF / DD? How are they similar? What are the important differences? In what ways are they moving together under Harmonization? Evaluate some of the key inputs to both, which should form the basis for SOP's explaining the development of each.
ComplianceOnline In this Laboratory Investigation training learn what constitutes an OOS observation, what are the guidance’s process & Steps to be taken in the laboratory in the event of an OOS observation.
Note: Use this Promo Code(103038) to avail Discount of 10% on LIVE Purchase.
ComplianceOnline This Radiation sterilization training will discuss how radiation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness.
ComplianceOnline This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product features and Validation (10 step risk based approach).
The Biomedical Associations of Wisconsin To be held at the Chula Vista Resort. The conference includes educational sessions, a keynote address by Leanne Cordisco of GE Healthcare & AAMI's Technology Management Council on "Clinical Engineering and IT: Navigating the Convergence," and a vendor exhibit.
Kentucky Healthcare Coalition Conference Kentucky Healthcare Coalition Conference - A 3-day conference featuring educational tracks by several Allied Health professions. Gary Slack addresses Kentucky Association for Medical Instrumentation attendees regarding Joint Commission inspections.
ECRI Institute Announces 17th Annual Conference This year’s health policy conference addresses the interface of personalized medicine and comparative effectiveness. The free 2-day program will be held at the National Institutes of Health.
Indiana Biomedical Society Celebrate this milestone and visit the Web site for more details.
2011 International Summit Exhibition on Health Facility Planning, Design Construction The PDC Summit provides senior level health care leaders, architects, and contractors with a forum to network and discuss the issues that impact the PDC process in today’s health care environment.
North Carolina Biomedical Association The symposium includes educational tracks and a vendor exhibit.
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