Thursday, August 23, 2012

Deadline 2013 – Implementing an Aggregate Spend Strategy

is being presented by Katherine Norris, Spectranetics & Kim Life, Life Compliance Solutions and airs on Tuesday, August 28th, 2012.  For more details or to register, please visit our site at

The Affordable Care Act has survived Supreme Court scrutiny and the physician payment sunshine provisions are set for implementation beginning in January 2013. As the timeframe for implementation narrows and final regulations still await reporting companies, pharmaceutical, medical device and biotechnology firms are primed to implement or refine approaches to recording, tracking, and reporting aggregate payments.

While money spent, per physician, on gifts, honoraria, consulting fees, food, research, continuing medical education and clinical investigator payments will be made public at the federal level for the first time in 2014, many states have existing requirements that have provided testing grounds for methodologies over the last several years. This audio conference presentation focuses on the myriad challenges facing firms at all stages of implementation, including selecting a vendor for your reporting solution, preparing your systems and implementation, auditing and monitoring.

Thursday, August 16, 2012

Implementing the FDA Guidance on Investigator Responsibility

is being presented by Lorry Witte, RN, BA, CCRC, CCRA, Clinical Research Consultant and airs on  Wednesday, August 22nd, 2012.  For more details or to register, please visit our site at

It's been some time since FDA released its guidance for industry on investigator responsibilities, but it remains important for investigators, study coordinators, and sponsor staff to regularly train on its content to ensure safe, high quality, efficient, and less costly clinical study conduct. With many studies, time is wasted on “cleaning up” study documentation. However, if all research staff members understand FDA’s current thinking on investigator responsibility, it becomes easier to collaborate in the subjects’ best interest and produce better study results.

This audio conference is intended help investigators and sponsors avoid FDA Form 483 findings and Warning Letters, highlighting what constitutes adequate investigator supervision, appropriate task delegation and adequate study training. Our speaker provides insight and guidance to assist investigators in developing or enhancing their plans for supervision and oversight of clinical trials. After attending the presentation, sponsor staff will be able to better identify robust investigator plans and understand sponsor responsibilities described in the guidance.
The presentation also reviews the protection of rights, safety and welfare of study subjects by providing reasonable medical care necessitated by clinical trial participation, reasonable access to medical care, and importance of avoiding protocol violations that present unreasonable risks for subjects.

Wednesday, June 6, 2012

Self-Assessment of Human Subjects Protection Programs

is being presented by Eric Allen, Director, Office of Research Compliance, with University of North Carolina at Greensboro and airs on Wednesday, June 13th, 2012. For more details or to register, please visit our site at

Sometimes being your own worst critic is a good thing. In the case of human subjects protection programs, it can prevent your institution from devastating negative impacts if you can handle the truth. Self-assessment is one option that shows the federal government, institutional officials, and your research communities your dedication to ethics and excellence in human participant research. This dynamic presentation demonstrates how periodic self-assessment of your human research protection program can be monumentally less painful than inspections by the Office of Human Research Protection or the FDA. Our speaker addresses core components including the regulatory parameters, procedures, personnel, training, and implementation of change(s). The presentation covers practical and cost-efficient strategies to implement a self-assessment program, along with tactical approaches to avoid pitfalls.

Wednesday, May 30, 2012

Process Capability Indices in Medical Device Manufacturing

is being presented by Dan O’Leary, President, of Ombu Enterprises, LLC, and airs on Thursday, June 7th, 2012.  For more details, or to register please visit our site at

Process capability analysis examines the inherent variability in a process, including the statistical distribution of the process output. When the measurement uses variables, data process variability is the “spread” of a process in statistical control. When the measurement involves attributes, process capability is often the proportion of nonconforming units. Often, process capability uses an index that relates process variability and process specifications.

This audio conference explains the underlying statistics of the most commonly used capability indices. In particular, the presentation shows how to use data from x-bar and R charts to calculate these process capability indices. With an understanding of process capability indices, the speaker then examines applications for medical devices. This immediately brings in the FDA QSR requirement to identify valid statistical techniques to control process capability and product characteristics. The audio conference illustrates applications of process capability indices in both FDA QSR and ISO 13485 systems using both examples and FDA Warning Letters to illustrate the issues.

Tuesday, May 15, 2012

Crisis Management for the FDA-Regulated Company

is being presented by Michael A. Swit, Esq., Special Counsel, FDA Practice, with Duane Morris LLP and airs on Tuesday, May 22nd, 2012. For more details, or to register please visit our site at

At any moment, lightning can strike your FDA-regulated company. It may take the form of an unexpected serious adverse event such as a death attributed to your product, forcing you to consider a recall -- or an FDA inspection exposing severe quality issues – or a tampering incident such as J&J faced twice with Tylenol®. Regardless of how the crisis arises, it is vital that your company be prepared in advance to address the crisis immediately and responsibly.

This audio conference looks at key issues and FDA-regulated company might face during a crisis related to products or operations regulated by FDA, and how to respond to them. Drawing on a real-life case study that directly involved the speaker – the generic drug scandal that rocked FDA and industry during the late 1980s – the presentation reviews how to be prepared for a crisis and how to respond when one arises.
One never expects to be struck by lightning, and if you are not prepared in advance, it likely will be too late to react in the best manner to protect not only the public health, but also to responsibly mitigate the impact on your company and all its stakeholders from employees to shareholders.