Life Cycle Management for Medical Diagnostics

Experience has shown that effective life cycle management (LCM) is critical to maintaining customer satisfaction, while minimizing waste and expense. This audio conference guides attendees through the critical moments of the diagnostic life cycle, beginning with the introduction of a new product, the "maintenance" of the product during its core lifetime, and finally, the obsolescence and likely replacement of the product in the field.

In this presentation our speaker, a 30-year veteran of the diagnostics industry, discusses the various aspects of effective life cycle management in the area of medical diagnostics and IVDs, while identifying key departments and their role in the life cycle management process.

Life Cycle Management for Medical Diagnostics is being presented by Anthony Eistetter, Senior Consulting Partner, with SciMed Parnters, Inc. and airs on Wednesday, October 7, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com

Proactively Manage Project Financials: Scope of Work, Cost to Complete & Scope Change

Effective management of project financials is absolutely integral to successful project management. It is essential to to establish a baseline budget, construct billing guides and calculate the Earned Value Analysis (EVA) with detailed projections of spend rates. In this session, the speaker discusses the change order process, including how to identify an out-of-scope item and/or scope creep, plus proactive approaches to manage your project financials.

This conference explores best practices on how to build a budget, analyze spend, proactively identify change orders and identify strategies to work within the budget. The speaker also reviews options for effectively controlling the budget.

Proactively Manage Project Financials: Scope of Work, Cost to Complete & Scope Change is being presented by Dr. Ann Flandermeyer, Senior Director, Project Management & Clinical Operations, with Covance and airs on Wednesday, October 14, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com

The 2010 MDD Revisions and What They Mean for Translation

Companies are scrambling to meet the new requirements of the 2010 European Medical Device Directive (MDD). One of the most challenging components of the new directive is the increased focus on language translation for software and labeling. The updated MDD states that software that is integral to the operation of a medical device must be translated into the languages of the countries in which the device will be sold. In the past, companies have been able to avoid software translation by stating that the great majority of professional device users can read English.

Software translation is no small feat. It can be expensive, time-consuming and a minefield for errors. But it doesn't have to be this way. Through implementing some best practices and avoiding common pitfalls, software translations can go smoothly. Notified bodies are now placing particular emphasis on the risks presented by inaccurate labeling and translations. Inaccuracies in labeling and IFUs can lead to incorrect use of a device, resulting in injury, death, notified body action, lawsuits and bad publicity. The root causes of inaccurate translations are many, but fortunately, these can be sidestepped through careful preparation, translator screening and efficient processes.

This presentation focuses on the implications of the 2010 MDD for translation. It also covers specific best practices and common pitfalls in software translation and labeling translation, and looks at some of the most common root causes of inaccurate labeling and how to avoid them.

The 2010 MDD Revisions and What They Mean for Translation is being presented by Jason Heaton, with ForeignExchange Translations and airs on Tuesday, October 6, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com

Building & Managing Cross-Cultural Teams

Members of clinical and research teams often come from a wide range of cultural backgrounds and countries. Each culture has unique communication and interaction customs. How can you most effectively encourage people from many diverse backgrounds to join your team, and most importantly, invite them to contribute to your organization's innovation and efficacy?

This audio conference reveals how best to recruit team members from all communities and encourage increased participation from each of them, regardless of their background. The speaker shares her insights on how to increase cultural competency, improve cross-cultural communication techniques and develop team members into leaders -- ensuring that succession planning is proactive, not reactive.

Building & Managing Cross-Cultural Teams is being presented by Wendy Willow Wark, Founder, of Inclusion Strategies and airs on Tuesday, October 6, 2009. For more details or to register, please visit our site at www.fxconferences.com

Ensuring GCP-Compliant Trials with Clinical Quality Audits

In the race to start and complete clinical trials, securing investigator, CRO, and sponsor GCP compliance can be an overwhelming task. Clinical quality audits are an essential tool in ensuring that clinical research is conducted in accordance with GCP requirements. Given the pressures of executing efficient and expedited research, including audits in your overall clinical investigative plan increases the quality of research data and protects sponsor investment. Addressing compliance issues early and consistently, through corrective and preventative action, enhances data integrity and the quality of the overall clinical trial.

This audio conference provides attendees with tips for an efficient and effective clinical audit strategy, along with tools to assist in conducting GCP audits of clinical investigators, clinical research organizations and sponsors.

Ensuring GCP-Compliant Trials with Clinical Quality Audits was presented by Carol Houts, Director of Regulatory, Quality and Safety, with Pleiad Inc. and aired on 2008-10-09. For more details or to download this conference, please visit our site at www.fxconferences.com