is being presented by Carsten Lund, Owner and Consultant, with Epsilon and airs on Thursday, May 13th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Measuring parts is a necessary, if sometimes tedious, part of the medical device manufacturing process. Often, this step takes more time than expected, with vast amounts of positions and tricky details to measure. However, with proper preparation it is possible to reduce the time needed for measurement – and time to market for the product – while still completing the product validation on solid ground.
This audio conference presentation discusses why measuring is necessary and looks at some of the latest initiatives in measuring strategy, including how to plan measurements and reduce the number of measurements, and at the same time gain valuable product and process knowledge. The speaker draws upon real-life examples from the injection molding process to highlight principles that can be applied for any automated or semi automated manufacturing process.
Monday, March 29, 2010
Friday, March 26, 2010
Developing Effective eLearning: Quick Reference Guide
is being presented by Christine Duckworth, President, with Intrac Design, Inc and airs on Tuesday, May 4th, 2010. For more details or to register, please visit our site at www.fxconferences.com
So you've finally convinced management to make an investment in eLearning technology. You have all the latest tools, from Flash to Lectora Publisher and Articulate. Now what?
As eLearning becomes more mainstream, companies are making the investment in technological infrastructure including Learning Management Systems (LMSs), authoring tools, and virtual classroom platforms. With the right tools in place, management has high expectations for engaging eLearning courseware that translates to workforce performance ROI.
However, most companies fail to invest the time or money in preparing training teams for the shift from an instructor-led training environment to eLearning. The new training paradigm has left many teams short on required skills and know-how to create engaging courseware. As a result, training departments are launching “page turners” that fail to engage the workforce and lack the learning integrity that leads to performance results.
This audio conference provides a “quick reference guide” for training teams, helping them to address the skills gap and to deliver the engaging eLearning courses that management and the target audience expect.
So you've finally convinced management to make an investment in eLearning technology. You have all the latest tools, from Flash to Lectora Publisher and Articulate. Now what?
As eLearning becomes more mainstream, companies are making the investment in technological infrastructure including Learning Management Systems (LMSs), authoring tools, and virtual classroom platforms. With the right tools in place, management has high expectations for engaging eLearning courseware that translates to workforce performance ROI.
However, most companies fail to invest the time or money in preparing training teams for the shift from an instructor-led training environment to eLearning. The new training paradigm has left many teams short on required skills and know-how to create engaging courseware. As a result, training departments are launching “page turners” that fail to engage the workforce and lack the learning integrity that leads to performance results.
This audio conference provides a “quick reference guide” for training teams, helping them to address the skills gap and to deliver the engaging eLearning courses that management and the target audience expect.
Thursday, March 25, 2010
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.
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.
Monday, March 22, 2010
Excel Spreadsheets and FDA Medical Device Regulations
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Thursday, April 29, 2010. For more details or to register, please visit our site at www.fxconferences.com
Excel spreadsheets can provide medical device manufacturers with valuable enhancements to production and quality systems. However, they must be implemented correctly and validated, and any records created must comply with FDA requirements.
When a device manufacturer uses an Excel spreadsheet, it must comply with two different parts of the FDA regulations. Following 21 CFR §820.70(i) Automated Processes, the manufacturer must validate the spreadsheets used in production or the quality system, and revalidate them when changes are made. Following 21 CFR Part 11, the manufacturer may also have created an electronic record. Device manufacturers must understand these regulations and the means to ensure compliance.
This presentation helps attendees understand the FDA device regulations related to Excel spreadsheets, beginning with methods to help ensure the spreadsheet produces the results you want. Our speaker explains how to use built-in validation tools, formula auditing and data, and also discusses the regulations for automated processes, found in 21 CFR §820.70(i), the requirements for a validation plan, and how to follow the FDA guidance document. The presentation also covers the electronic record aspects of the spreadsheet – requirements for electronic records and the issues raised, the current FDA guidance document, where FDA will exercise “regulatory discretion”, and what that means.
Excel spreadsheets can provide medical device manufacturers with valuable enhancements to production and quality systems. However, they must be implemented correctly and validated, and any records created must comply with FDA requirements.
When a device manufacturer uses an Excel spreadsheet, it must comply with two different parts of the FDA regulations. Following 21 CFR §820.70(i) Automated Processes, the manufacturer must validate the spreadsheets used in production or the quality system, and revalidate them when changes are made. Following 21 CFR Part 11, the manufacturer may also have created an electronic record. Device manufacturers must understand these regulations and the means to ensure compliance.
This presentation helps attendees understand the FDA device regulations related to Excel spreadsheets, beginning with methods to help ensure the spreadsheet produces the results you want. Our speaker explains how to use built-in validation tools, formula auditing and data, and also discusses the regulations for automated processes, found in 21 CFR §820.70(i), the requirements for a validation plan, and how to follow the FDA guidance document. The presentation also covers the electronic record aspects of the spreadsheet – requirements for electronic records and the issues raised, the current FDA guidance document, where FDA will exercise “regulatory discretion”, and what that means.
Friday, March 19, 2010
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.
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.
Wednesday, March 17, 2010
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.
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.
Friday, March 12, 2010
3 Steps to Successful Translation Management
is being presented by Andres Heuberger, President, of ForeignExchange Translations, and airs on Tuesday, April 27th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Translators have been around since the time of the Babylonians, yet the US translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but pharmaceutical, device and diagnostics companies need a true partner that can help them effectively manage the translation process.
This audio conference gives you the skills to evaluate different vendors, service delivery methods and quality. It also enables you to put in place a process to document, measure, audit and improve your overall translation activities.
Translators have been around since the time of the Babylonians, yet the US translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but pharmaceutical, device and diagnostics companies need a true partner that can help them effectively manage the translation process.
This audio conference gives you the skills to evaluate different vendors, service delivery methods and quality. It also enables you to put in place a process to document, measure, audit and improve your overall translation activities.
Thursday, March 11, 2010
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.
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.
Monday, March 8, 2010
Medicare Coverage of Clinical Trials: Opportunities & Obstacles
is being presented by Dr. Edward Berger, Larchmont Strategic Advisors and airs on Wednesday, April 14, 2010. For more details or to register, please visit our site at www.fxconferences.com
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 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.
Thursday, March 4, 2010
Periodic Safety Update Reports: Be Compliant and Cost Effective
is being presented by Dr. Hemendra Misra & Mark Nelson Tyrrell, with PRA International and airs on Tuesday, March 23, 2010. For more details or to register, please visit our site at www.fxconferences.com
Periodic Safety Update Reports (PSURs) are a regulatory requirement in the European Union, Japan, and in an increasing number of ICH and non-ICH countries. The US FDA, in conjunction with the goal to harmonize reporting globally, also accepts a PSUR in place of the Periodic Adverse Drug Event Report (PADER).
Planning and writing of PSURs involve significant effort and costs. In times of peak workload, pressing timelines or competing priorities, maintaining compliance becomes a challenge. Lessons learned from the industry were employed to develop customized strategies to keep up with the associated regulatory, scientific and public health demands.
Periodic Safety Update Reports (PSURs) are a regulatory requirement in the European Union, Japan, and in an increasing number of ICH and non-ICH countries. The US FDA, in conjunction with the goal to harmonize reporting globally, also accepts a PSUR in place of the Periodic Adverse Drug Event Report (PADER).
Planning and writing of PSURs involve significant effort and costs. In times of peak workload, pressing timelines or competing priorities, maintaining compliance becomes a challenge. Lessons learned from the industry were employed to develop customized strategies to keep up with the associated regulatory, scientific and public health demands.
Wednesday, March 3, 2010
Medical Device Vigilance Planning under the Revised MDD
is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Tuesday April 13, 2010. For more details, please visit our site at www.fxconferences.com
Manufacturers placing medical devices on the market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS). In the EU the medical device directives (MDDs) establish the principal mechanisms for providing feedback about medical devices. Provisions regarding vigilance and PMS are outlined in various annexes to the MDDs: Active Implantable Medical Devices Directive (AIMDD); Medical Devices Directive (MDD), as amended; and In Vitro Device Directive (IVDD), as amended.
This audio conference provides information on various aspects of the legislation and how it is affecting medical device manufacturers, including real-life experiences to date and lessons learned from those who have been through the process.
Manufacturers placing medical devices on the market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS). In the EU the medical device directives (MDDs) establish the principal mechanisms for providing feedback about medical devices. Provisions regarding vigilance and PMS are outlined in various annexes to the MDDs: Active Implantable Medical Devices Directive (AIMDD); Medical Devices Directive (MDD), as amended; and In Vitro Device Directive (IVDD), as amended.
This audio conference provides information on various aspects of the legislation and how it is affecting medical device manufacturers, including real-life experiences to date and lessons learned from those who have been through the process.
Tuesday, March 2, 2010
Building Better Clinician Relationships
is being presented by Clair Callan, CEO and Founder, of Callan Consulting and airs on Tuesday, April 8, 2010. For more details or to register, please visit our site at www.fxconferences.com
The health care environment is in a state of flux, and hospitals and physicians must deal with constant change and a variety of other challenges in meeting their goal of providing the best patient care possible. The good news for drug and device companies is that there exist within this climate opportunities for expanding and strengthening the relationships between clinicans and industry. Life sciences companies can add value by providing information and training sessions, ideas for expanded use of products within the scope of regulatory approval, and advice on how to get approval for expanded use of already approved technology.
In this audio conference, attendees learn ways in which they can capitalize on the current health care environment to further develop their clinican relationships, how this benefits both doctors and their patients, and why it simply makes good business sense.
The health care environment is in a state of flux, and hospitals and physicians must deal with constant change and a variety of other challenges in meeting their goal of providing the best patient care possible. The good news for drug and device companies is that there exist within this climate opportunities for expanding and strengthening the relationships between clinicans and industry. Life sciences companies can add value by providing information and training sessions, ideas for expanded use of products within the scope of regulatory approval, and advice on how to get approval for expanded use of already approved technology.
In this audio conference, attendees learn ways in which they can capitalize on the current health care environment to further develop their clinican relationships, how this benefits both doctors and their patients, and why it simply makes good business sense.
Monday, March 1, 2010
New audio conference website is now live
Over the past 8+ years, ForeignExchange's dedicated audio conference team produced hundreds of events for thousands of attendees. This effort has become an important educational tool for ForeignExchange, our clients, and our suppliers.
Our team continually improves the usability of FxConferences.com, the web site for our audio conference program, and we are happy to announce that a major site redesign has just been successfully completed.
The new FxConferences.com features a substantially improved user interface. Event information is better laid out - from the results list to the event abstracts themselves. FxConferences.com now provides streamlined information in a central location.
Here are the main changes and improvements that we made (for comparison, take a look at our old audio conference site) :
- The search functionality is much deeper, creating advanced search capabilities and better industry and department-specific yields.
- The results of your searches are highly sortable, enabling users to list titles by date, name, department, or industry.
- The new site is aesthetically more pleasing - it looks really great!
- Users have much better access to other audio conferences by the same speaker or company.
ForeignExchange produces almost-daily audio conferences around regulatory, clinical, quality, financial, and medical translation topics. Visit us at FxConferences.com to learn more.
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