Conducting Vendor Audits from an IT Perspective

is being presented by Terri Mead, President, of Solutions2Projects, LLC and airs on Wednesday, May 25th, 2011. For more details or to register, please visit our site at www.fxconferences.com

In the past, vendor audits were standard practice prior to the purchase of, or as part of validating, an IT system. As resources have gotten tighter and life sciences companies perhaps perceived less of a threat from the FDA on computer validation, many companies have moved away from performing vendor audits.

These days, FDA is scrutinizing IT systems, and has not overlooked the tendency with many companies to try and justify their way out of conducting vendor audits. This is true for both the outsourcing of processes to CROs and the implementation of IT systems on-site. With FDA’s focus on computer systems as part of PAIs and other inspections, ignoring vendor audits is a risk you can’t afford to take.

This audio conference presentation takes attendees through the elements of a vendor audit for both the purchase of software for a validated system, and for outsourcing of services that include IT systems such as clinical trial management.

Establishing Win-Win Relationships With Internal Clients

is being presented by Herb Cohen, Senior Managing Partner, with Performance Connections International, Inc. and airs on Wednesday, September 29th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

Successful scientists, engineers and IT professionals realize the importance of developing ongoing and productive “win-win” relationships with others outside their own department. Especially when resources are stretched, influencing and negotiating with coworkers in different areas of the company to gain their time and commitment to meet your needs is critical to the success of your business.

When your goal is to influence coworkers, you often face unique challenges and issues. While you and your coworkers all support the greater needs of the company, understanding each other’s individual and departmental issues is important in getting results. This isn’t always simple to do, and, in fact, can become even more complicated when you must make your case to a group, rather than to an individual.

This audio conference discusses how the genetic wiring of most technical professionals is different than other occupational groups. Speaker Herb Cohen explains how to resolve issues in a positive way that maintains the internal customer relationship, and shares top strategies that are mutually beneficial to everyone and that will benefit you and your company in both the short and long term.

Cloud Computing for the FDA-Regulated Company

is being presented by John English, Principal, John T. English Regulatory Consulting and airs on Thursday, July 15th, 2010. For more details or to register, please visit our site at www.fxconferences.com

Your inbox and the media are both full of offerings and commentary on cloud computing. What exactly is it? Why are IT and finance people so bullish on it? Are there regulatory implications to embracing this strategy?

This presentation looks at the technical aspects of the 'cloud' paradigm in terms appropriate for the non-IT professional. The speaker uses this information, along with current examples from industry, to explain the fiscal and technical advantages that are driving many companies to explore and/or adopt this approach. The presentation also reviews and analyzes some basic issues an FDA-regulated company must understand and take into account before jumping on the cloud computing bandwagon.

Keeping Technical Professionals Engaged - Retaining Scientists, Engineers & IT

is being presented by Bruce Fern, Chief Engagement Officer, with Performance Connections International, Inc and airs on Wednesday, June 9th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com

Current research points to the erosion of employee engagement as the single greatest business challenge that organizations face today. The majority of your scientists, engineers and IT professionals are working hard, but given the economic difficulties we now face, longer hours, time pressures and on-going uncertainty is having an adverse affect on today’s technical workforce. Innovation, quality, collaboration and time to market are all compromised if you have a technical workforce which is not fully engaged. And there is a unique set of challenges that come with engaging technical professionals.

In this audio conference, Bruce Fern, Chief Engagement Officer at Performance Connections, presents research on how the genetic wiring of most technical professionals is different than other occupational groups, the newest research on engagement and how it relates to the technical workforce, and top strategies for engaging technical professionals.

Best Practices for Implementing An eClinical Program

is being presented by John Aggerholm, Founder & Partner, with HERAX and airs on Thursday, April 15th, 2010. For more details or to register, please visit our site at www.fxconferences.com

When implementing an eClinical program in order to optimize processes and improve the use of IT, it is important to focus on benefits. This focus, together with enabling the clinical development and IT organizations to meet around a common vision for improving the business processes, are the most important part of setting up an eClinical program.

This presentation shows how to create a eClinical program based on real-life experiences from several major pharmaceutical companies, with practical case samples of the benefits achieved, what processes were in focus and how the change management was planned and carried out to ensure the programs actually worked. The examples will be taken from clinical operations, clinical trial management systems (CTMS) and EDC usage, integration and CDISC standardization cases in different eClinical programs. These case studies show how to escape the silo approach and improve the clinical development process across departments.

Using IT to Drive Quality Healthcare

Technology has evolved to the critical point of capability and proven maturity to enable appropriate healthcare applicability. Health information technology has the ability to provide improved healthcare quality, more efficient delivery of care and earlier diagnosis of disease, while at the same time positively affecting your bottom line.

In this presentation our speaker reviews the pressures on healthcare, the IT-related capabilities needed, and proof from real organizations of outcomes achieved through IT-enhanced healthcare. The presentation also provides illustrations of improved patient safety and practitioner efficacy through IT-enabled healthcare.

Using IT to Drive Quality Healthcare is being presented by Dr. Steven Shaha, Principal Outcomes Consultant, with Eclipsys Corporation and airs on Wednesday, February 3, 2010. For more details or to register, please visit our site at www.fxconferences.com