Keep Pace with Industry: Updating Training Content Dynamically

is being presented by David Glow, Chief Learning Architect and airs on Wednesday, January 26th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com

Every organization is responsible for deploying and maintaining training in a timely manner to keep pace with industry Employees require support and information to perform, especially during times of rapid change. This is paramount in businesses operating in highly regulated environments such as healthcare and financial services, where changes are not only rapid, but compliance is mandatory.

Many companies struggle in deploying new training resources or updating existing resources in a timely manner. Most organizations use a development model that is not efficient, and often duplicates efforts. Common development models delay deployment time which leaves the workforce under prepared on required skills.

This audio conference provides several practical approaches for organizations to employ a training system design to dynamically update content to keep pace with necessary business and industry changes.

Complying with Employment Law When Interviewing & Hiring

is being presented by Marna Hayden, Founder and President, of Hayden Resources Inc. and airs on Thursday, December 2nd, 2010. For more details or to register, please visit our site at www.fxconferences.com

Hiring the right people is one of the most important jobs any human resources professional or manager does. From the entrance level recruiter to the seasoned professional in charge of executive hiring, this audio conference provides practical pointers on hiring best practices and pitfalls.

The presentation covers the interviewing and selection process from the perspective of compliance to applicable employment laws, and reviews each step. It covers what is allowed, what may be discriminatory, and what specific questions should not be asked in an employment interview. Our speaker also discusses how best to evaluate a candidate, how to measure what constitutes adverse impact in hiring, and how to legally conduct reference and background checks.

Developing Your 5010 and ICD-10 Compliance Strategy

is being presented by Frank O'Roark & George Brill, Managing Partners, AlphaPoint Consulting and airs on Tuesday, May 11, 2010. For more details or to register, please visit our site at www.fxconferences.com

The US Department of Health & Human Services has published two important changes to the HIPAA standards, both of which will have a significant impact on hospitals, physicians, pharmacies and health plan providers. The X12 Version 5010 sets a new standard for exchanging electronic financial information, while ICD-10 modifies the data code sets for diagnoses and in-patient procedures.

With compliance deadlines looming, many organizations lack a clear understanding of the potential impact, and assume a simple mapping exercise will solve most of their 5010 and ICD-10 issues. While mapping and translating the version 4010A1 transactions to the 5010 transactions may support continued electronic data interchange between providers and health plans, mapping 55,000 new ICD-10 diagnosis codes and 84,000 new procedure codes to the ICD-9 codes has limited application and sustainability for processing claims.

This audio conference looks at 5010 and ICD-10 regulatory compliance strategies and the key points healthcare organizations need to be addressing now, including assessment/impact analysis, implementation planning, remediation, contingency planning, training and testing.

Thinking Beyond Compliance: Medical Device Product Development

is being presented by Noel Sobelman, Partner, with Kalypso and airs on April 28th, 2010. For more details or to register, please visit our site at www.fxconferences.com

For today's medical device companies, implementing new product development (NPD) processes that comply with increasing regulatory requirements is a challenge. Many have inadvertently deployed overly bureaucratic systems and, as a result, have found themselves with increasing costs and slowing development.

This audio conference discusses recommendations for re-defining NPD processes and systems to balance compliance requirements with time-to-market and development effectiveness initiatives. Based on the results of a research study involving 20 medical device companies, the presentation explores how they find the right balance between what can seem like competing objectives.

Optimizing Regulatory Compliance Throughout the Drug Development Process

is being presented by Dr. Ruth Ann Lee, Director and Executive Consultant, Scientific Consulting, with Beckloff Associates, Inc. and airs on Tuesday, April 20, 2010. For more details or to register, please visit our site at www.fxconferences.com

Compliance is not passive! The regulatory agencies expect you to continuously evaluate and monitor your state of compliance, maintain compliance, and ensure sustained compliance. By understanding the interplay of regulations as the drug substance and drug product transition from lead compound through final commercialization, a drug development program can be optimized to prevent delays that can result in lost time, delayed return on investment and a shorter market life cycle.

This audio conference provides an overview of the regulatory compliance requirements through the various phases of product development. The speaker discusses the take-away message from current FDA compliance activities and present options to prevent, respond, and remediate compliance issues as necessary.

Registering Device Trials on ClinicalTrials.gov

It has been a full year since Title VIII of the Food and Drug Administration Amendments Act of 2007 expanded the scope of information that must be registered in ClinicalTrials.gov. Along with mandating the inclusion of medical device trials, additional requirements included increasing the amount of trial information, requiring results, and setting penalties for noncompliance.

One year later, the medical device community still has a lot of questions about requirements and responsibilities to comply with Title VIII, and the FDA is working to provide the answers and guidance.

In this audio conference, you will learn the latest information on registration of medical device trials and what you must do for compliance.

Registering Device Trials on ClinicalTrials.gov was presented by Amy Wise, Manager of Clinical Research, with PharmaNet and aired on 2008-11-13. For more details, or to download this event 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

Regulatory and Scientific Considerations for API Drug Development

The establishment of a robust Active Pharmaceutical Ingredient (API) development program is an integral part of drug development. A well-planned API development program that is properly integrated with the drug product, clinical, non-clinical and marketing programs is essential to prevent delays that can result in lost time, revenues and market life cycle.

This audio conference provides an overview of the scientific, regulatory and compliance requirements of API development at the various phases of development. The speaker also discusses special considerations associated with API development such as APIs manufactured from biological sources, the use of DMFs, and the management of manufacturing contractors.

Regulatory and Scientific Considerations for API Drug Development is being presented by Dr. William Putnam, Director, Executive Consultant, Scientific Consulting, with Beckloff Associates, Inc. (a Cardinal Health company) and airs on Wednesday, August 26, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

How to Mark & Label Devices Under IEC60601-1 3rd Edition

Get up to speed on the latest requirements incorporated into the 3rd Edition of IEC 60601-1 and take the guesswork out of marking and labeling your medical devices.

Marking and labeling is just one area to tackle in the complicated development of medical devices, but it is a critical one to understand. How do you make sense of all those regulations? It’s challenging enough preparing and testing the device; then you have to worry about the user manuals, screen prompts and packaging too!

In this audio seminar, Leo Eisner guides you through each new, added or modified regulation incorporated into the most recent revision of IEC 60601-1. The third edition of this cornerstone standard for medical electrical devices sees major changes from version two you need to know for successful compliance. Ease your marking and labeling stress with detailed guidance from a leading expert.

How to Mark & Label Devices Under IEC60601-1 3rd Edition was presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and aired on 2007-10-23. For more details or to download this conference, please visit our site at www.fxconferences.com

Ensuring Compliance in Global Clinical Trials

An increasingly intense competitive environment and the shrinking pools of treatment populations in traditional markets has forced drug companies to ‘go global’ and approach emerging markets to place research and secure enrollment. But how do you ‘go global’ without sacrificing consistency and quality in clinical trials?

This audio conference discusses the unique challenges posed by international clinical trials, and provide a regulatory expert view of how to overcome these challenges and ensure compliance across various countries and geographic regions.

Ensuring Compliance in Global Clinical Trials was presented by Bruce Wagman, Vice President Regulatory & QA Services, with Covance, Inc. and aired on 2008-04-24. For more details or to download this conference, please visit our site at www.fxconferences.com

Medicare Coverage of Clinical Trials: Opportunities & Obstacles

Medicare can help companies defray the cost of drug and device clinical trials by paying for some services delivered to program beneficiaries enrolled in “qualified” trials. In considering whether to seek Medicare coverage, trial sponsors and clinical sites need to be aware of the administrative obstacles introduced by the need to comply with fraud and abuse regulations and the Secondary Payer Statute.

This conference provides a detailed review of Medicare’s clinical trial coverage policies, the different rules that apply to device (IDE) and pharmaceutical (IND) trials, and the compliance issues that complicate the decision to seek Medicare funding.

Medicare Coverage of Clinical Trials: Opportunities & Obstacles is being presented by Dr. Edward Berger, Principal, with Larchmont Strategic Advisors and airs on Tuesday, July 21, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com

Website Access: Ensuring Compliance with Section 508 and the ADA

People with disabilities are one of the largest and fastest growing minority groups, with over $220 billion in discretionary income in the US alone. But beyond the business case, access to electronic and information technology by persons with disabilities is protected by law, including Section 508 of the U.S. Rehabilitation Act. Section 508 requires that electronic and information technology developed or purchased by the federal government is accessible by people with disabilities, and government procurement officers are strictly prohibited from doing business with any company that is not Section 508 compliant.

Currently, there are major changes underway in accessibility legislation that all companies must be aware of and prepared to address. Section 508 is under revision, there have been recent amendments to the Americans with Disabilities Act, and the UN is expected to soon ratify the Convention on the Rights of Persons with Disabilities, which includes IT accessibility mandates. This audio conference highlights the changes that will impact your company, and provides important information on compliance.

Website Access: Ensuring Compliance with Section 508 and the ADA is being presented by Debra Ruh, Founder & CEO, with TecAccess and airs on Wednesday, July 8, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Best Practices for Implementing ISO14971:2007

Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971.

In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Manufacturers, however, still struggle to comply with ISO14971 and find a meaningful way to introduce risk management to the overall operating framework.

In this audio conference, Mr. Weber discusses the elements of risk management, the current interpretations of regulatory requirements, as well as advice on implementation of a compliant risk management process. Additionally, the presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.

Best Practices for Implementing ISO14971:2007 aired on 2008-02-21 and is available for download at www.fxconferences.com

Conducting Exploratory Trials in Scandinavia

Debating where to take your trial? While emergent research settings like India and Asia have captured much of the media spotlight in recent years, there are few places in the world better-suited for phase 1 and phase 2 clinical trials than Scandinavia. Populations in the Nordic region are ethnically homogeneous with a majority of caucasians. Both governments and populations generally display a positive attitude toward clinical research, and trial participants have high compliance rates. All citizens have free and equal access to healthcare, preventing sampling bias due to differences in social status. Health care facilities in the region all have access to state-of-the-art medical equipment, and the infrastructure is of the highest standards. In this audio conference, the speaker discusses these and other factors that make the Scandinavian countries a leading choice for exploratory trials.

Conducting Exploratory Trials in Scandinavia is presented by Dr. Claes Strom, Partner and COO, of aCROnordic and airs Thursday, Oct. 30, 2008. For more details please visit our site www.fxconferences.com

Maximizing Productivity Among Spanish-Speaking Employees

On occasion, even when material and instructions are translated well, employers do not get the response that they need from Spanish-speaking employees. This happens not because of a lack of desire to be a valuable employee, but because of Spanish speakers’ misconceptions about what it takes to be a valuable employee in the United States.

In this audio conference we will address common challenges for employers---apart from the language barrier---and will offer various strategies for improving morale and encouraging desired behavior like compliance with training and regulation and participation in benefit plans.

This event is presented by Melissa Burkhardt of Futuro Sólido. To learn more, please visit www.fxconferences.com.

The ABCs of FDA: Regulatory, Fraud and Abuse Issues

More and more companies are venturing into medical devices, drugs or biologics in an effort to diversify or to promote new biotechnologies. At the same time, the United States government is taking a more active role in regulating the manufacturers, providers and payers in the healthcare industry. The collision of these two trends – increased interest in marketing healthcare products along with increased government involvement in regulation and enforcement – require companies to attain FDA regulatory compliance and prevent fraud and abuse violations in order to be successful in this industry and avoid multi-million dollar fines and penalties.

In this audio conference, the speaker will address the basic things that people and companies need to know about dealing with the FDA and succeeding in the life sciences industry.

This event is presented by Bethany Gilbert of Hodgson Russ. To learn more, please visit www.fxconferences.com.