is being presented by Robert J. Klepinski, Regulatory Attorney, Of Counsel, with Fredrikson & Byron and airs on Thursday, July 1st, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com
Manufacturers of medical devices and drugs had enough exemptions in the HIPAA privacy regulation that they could obtain most needed information in spite of the stringent controls on privacy rights. Occasionally such manufacturers needed to work under a Business Associate Agreement (BAA). However, the new statutory changes, including the privacy provisions of the HITECH Act, greatly increase the risk to manufacturers who work under BAAs. They are now directly liable under the HIPAA security regulations.
In this audio conference, FDA compliance attorney Bob Klepinski discusses the implications of this latest round of changes, how drug and device companies are expected to conduct themselves within this new HIPAA world, and the perils of failing to do so.
Monday, May 31, 2010
Friday, May 28, 2010
A Common Sense Approach to FDA and ISO Compliance
is being presented by Susan Soderholm, Quality Manager & Certified Quality Auditor, Amcor Rigid Plastics and airs on Tuesday, June 29th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Regulatory agencies are 'upping the ante' with regards to implied and written compliance. As they currently exist, the ICH guidance documents may or may not be issued. Our global marketplace makes it critical to understand the linkages between FDA, ISO and ICH requirements to have a quality system that meets all requirements in the broad customer base – in particular, 21CFR211/820, ISO 13485, ISO 9001 and ICH Q8, Q9, Q10 and IPEC 2006 requirements, similarities and differences.
Preparation for a successful audit, product approval and a compliant Quality Management System is key to compliance and ultimately, product and site approval. In this audio conference, our speaker draws on extensive experience in hosting regulatory agency and customer audits, as she shares practical experience and established best practice approaches.
Regulatory agencies are 'upping the ante' with regards to implied and written compliance. As they currently exist, the ICH guidance documents may or may not be issued. Our global marketplace makes it critical to understand the linkages between FDA, ISO and ICH requirements to have a quality system that meets all requirements in the broad customer base – in particular, 21CFR211/820, ISO 13485, ISO 9001 and ICH Q8, Q9, Q10 and IPEC 2006 requirements, similarities and differences.
Preparation for a successful audit, product approval and a compliant Quality Management System is key to compliance and ultimately, product and site approval. In this audio conference, our speaker draws on extensive experience in hosting regulatory agency and customer audits, as she shares practical experience and established best practice approaches.
Monday, May 17, 2010
Best Practices for Managing In-Country Translation Reviews
is being presented by Andres Heuberger, President, of ForeignExchange Translations, and airs on Thursday, June 24th, 2010. For more details or to register, please visit our site at www.fxconferences.com
It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
With proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches. This presentation shows you how.
It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
With proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches. This presentation shows you how.
Friday, May 14, 2010
How to Avoid GCP Non-Compliance Issues in Your Clinical Trials
is being presented by Dr. Howard Hubbell, President, of Hubbell Consulting, LLC and airs on Tuesday, June 22nd, 2010. For more details or to register please visit our site at www.fxconferences.com
Good Clinical Practice (GCP) is a set of ethical and operational principles which assure that the conduct of clinical trials and the data derived from those trials protect the participating human subjects and assure the quality, reliability and integrity of the clinical data. Because of the complexity of clinical trials, multiple personnel in the trial process have responsibilities for maintaining GCP compliance. However, in many instances, clinical trials are GCP non-compliant in at least one component of the study, at some point during the study. Depending on the non-compliant issues, GCP non-compliance can potentially lead to warning letters, suspension of the trial or rejection of some or all of the trial data by regulatory agencies.
In this audio conference, the speaker defines GCP, outlines the roles of those working on various aspects of the clinical trial (including sponsors, investigators, CROs, monitors and IRBs) and describes the documents necessary for performing a clinical trial. In addition, regulatory inspections and audits of clinical trials are discussed, along with common GCP non-compliance findings and resultant regulatory actions. Strategies and actions will be presented for maintaining GCP compliance.
Good Clinical Practice (GCP) is a set of ethical and operational principles which assure that the conduct of clinical trials and the data derived from those trials protect the participating human subjects and assure the quality, reliability and integrity of the clinical data. Because of the complexity of clinical trials, multiple personnel in the trial process have responsibilities for maintaining GCP compliance. However, in many instances, clinical trials are GCP non-compliant in at least one component of the study, at some point during the study. Depending on the non-compliant issues, GCP non-compliance can potentially lead to warning letters, suspension of the trial or rejection of some or all of the trial data by regulatory agencies.
In this audio conference, the speaker defines GCP, outlines the roles of those working on various aspects of the clinical trial (including sponsors, investigators, CROs, monitors and IRBs) and describes the documents necessary for performing a clinical trial. In addition, regulatory inspections and audits of clinical trials are discussed, along with common GCP non-compliance findings and resultant regulatory actions. Strategies and actions will be presented for maintaining GCP compliance.
Thursday, May 13, 2010
Complying with Breach Notification Provisions of the HITECH Act
is being presented by Kate Borten, President, of The Marblehead Group and airs on Thursday, June 17th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
The HITECH Act’s requirement for breach notification is the first national law – and the most sweeping – to call for the notification of individuals whose Protected Health Information (PHI) has been breached. The law and subsequent HHS rule are enforceable now, and organizations that incur a breach and fail to fulfill all of the standards are subject to both state and federal penalties.
This audio conference summarizes the breach notification requirements under the HITECH Act, highlighting areas that are particularly challenging for organizations, such as defining incidents and determining harm. It explains how breach notification steps fit into the mandated incident response plan and the need for proactive planning. Additionally, the speaker draws upon several real-life case studies to highlight important lessons learned.
The HITECH Act’s requirement for breach notification is the first national law – and the most sweeping – to call for the notification of individuals whose Protected Health Information (PHI) has been breached. The law and subsequent HHS rule are enforceable now, and organizations that incur a breach and fail to fulfill all of the standards are subject to both state and federal penalties.
This audio conference summarizes the breach notification requirements under the HITECH Act, highlighting areas that are particularly challenging for organizations, such as defining incidents and determining harm. It explains how breach notification steps fit into the mandated incident response plan and the need for proactive planning. Additionally, the speaker draws upon several real-life case studies to highlight important lessons learned.
Wednesday, May 12, 2010
CGMP Guidance for Phase 1 Clinical Supplies
is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, June 15th, 2010. For more details or to register please visit our site at www.fxconferences.com
The new FDA guidance document for Phase 1 clinical supplies is significant because it will enable companies (large and small) to move faster through their clinical manufacturing process, while not being bogged down with complying with all aspects of 21CFR Part 211. FDA realized that the CGMPs should not have been enforced for Phase 1 clinical supplies. This guidance document focuses primarily on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. It allows flexibility in implementing the controls needed to achieve those goals. In this audio conference, our speaker reviews the guidelines, identifies the types of SOPs and controls that are needed, and identifies for the virtual company, what types of SOPs are needed to deal with vendor relationships.
The new FDA guidance document for Phase 1 clinical supplies is significant because it will enable companies (large and small) to move faster through their clinical manufacturing process, while not being bogged down with complying with all aspects of 21CFR Part 211. FDA realized that the CGMPs should not have been enforced for Phase 1 clinical supplies. This guidance document focuses primarily on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. It allows flexibility in implementing the controls needed to achieve those goals. In this audio conference, our speaker reviews the guidelines, identifies the types of SOPs and controls that are needed, and identifies for the virtual company, what types of SOPs are needed to deal with vendor relationships.
Tuesday, May 11, 2010
Reducing the Impact of Risk Management on Development Budgets and Timelines
is being presented by Dr. Joy Frestedt, President & CEO, with Frestedt Incorporated and airs on Thursday, June 10th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Managing risk is an evolving specialty, and is becoming more critical thanks to increasingly strict global regulatory requirements for risk evaluation and management. No longer is simply recording and reporting adverse events sufficient to demonstrate due diligience for ensuring consumer safety. The need to proactively track, trend and attempt to predict risk-related issues is now critical and is a required part of every drug, device and biological design program.
This audio conference presentation looks at current trends in risk management, and how it can impact development budgets and timelines for drug and device manufacturers. Our speaker also shares valuable insight on practical activities and the training required to effectively reduce costs and speed timelines when conducting risk evaluation and mitigation strategies.
Managing risk is an evolving specialty, and is becoming more critical thanks to increasingly strict global regulatory requirements for risk evaluation and management. No longer is simply recording and reporting adverse events sufficient to demonstrate due diligience for ensuring consumer safety. The need to proactively track, trend and attempt to predict risk-related issues is now critical and is a required part of every drug, device and biological design program.
This audio conference presentation looks at current trends in risk management, and how it can impact development budgets and timelines for drug and device manufacturers. Our speaker also shares valuable insight on practical activities and the training required to effectively reduce costs and speed timelines when conducting risk evaluation and mitigation strategies.
Monday, May 10, 2010
Off-Label Information for Medical Device Companies: Regulation, Dissemination & Enforcement
is being presented by Caryn Silverman, Partner, with Sedgwick, Detert, Moran & Arnold LLP and airs on Thursday, June 3rd, 2010. For more details or to register please visit our site at www.fxconferences.com
Off-label promotion is a perennial hot topic within the life sciences. The rules can appear ambiguous at times, but the consequences of running afoul of FDA and other enforcement authorities are serious indeed. In this audio conference, our speaker provides background information and examines the current regulatory status of off-label promotion of medical devices. The presentation also looks at the "how-tos" for dissemination of off-label information; the role of sales representatives and medical science liaisons (MSLs), and the practical application of the FDA's January 2009 guidance on reprints.
This session also examines the consequences of off-label promotion, reviews some actual enforcement actions taken against medical device companies by FDA, and the roles of the Office of the Inspector General, U.S. Attorney's Office and state governments.
Off-label promotion is a perennial hot topic within the life sciences. The rules can appear ambiguous at times, but the consequences of running afoul of FDA and other enforcement authorities are serious indeed. In this audio conference, our speaker provides background information and examines the current regulatory status of off-label promotion of medical devices. The presentation also looks at the "how-tos" for dissemination of off-label information; the role of sales representatives and medical science liaisons (MSLs), and the practical application of the FDA's January 2009 guidance on reprints.
This session also examines the consequences of off-label promotion, reviews some actual enforcement actions taken against medical device companies by FDA, and the roles of the Office of the Inspector General, U.S. Attorney's Office and state governments.
Friday, May 7, 2010
Running Home-based Clinical Trials for Medical Devices and Diagnostics
is being presented by Helen Colquhoun, CEO, of Pleiad Inc and airs on Tuesday, June 1st, 2010. For more details or to register, please visit our site at www.fxconferences.com
The FDA recently (20 April 2010) issued a news release about formulating guidance about the challenges of using complex medical devices in the home. There are many devices and diagnostics that are or could be used by patients in their own homes: in-vitro diagnostics with complex software algorithms and connections to computer databases and websites; haemodialysis machines; ventilators; artificial hearts; intravenous infusion pumps; and various types of wound-care devices. Home-based use of complex devices to treat liver disease, depression, and heart disease are in development. In fact, any complex device that delivers therapy over a prolonged period of time needs to accommodate home-use because payers will not pay for and patients will not attend prolonged hospital or clinic-based treatment regimens. There is good evidence from patients with renal failure on dialysis that more frequent, short-duration treatment sessions improve clinical outcomes and that may be true of many therapies delivered by complex devices.
In order to obtain labelling that allows use of a complex device or a diagnostic in the home, clinical data need to be obtained that demonstrate that patients of different ages, with different education and professional backgrounds, and different physical abilities (the so-called human factors), can all use the device or diagnostic successfully in the intended setting (the home). Setting up and managing clinical trials in patients' homes is very challenging but not impossible. In this audio conference, Dr. Helen Colquhoun describes these challenges and how best to meet them, using liberal examples.
The FDA recently (20 April 2010) issued a news release about formulating guidance about the challenges of using complex medical devices in the home. There are many devices and diagnostics that are or could be used by patients in their own homes: in-vitro diagnostics with complex software algorithms and connections to computer databases and websites; haemodialysis machines; ventilators; artificial hearts; intravenous infusion pumps; and various types of wound-care devices. Home-based use of complex devices to treat liver disease, depression, and heart disease are in development. In fact, any complex device that delivers therapy over a prolonged period of time needs to accommodate home-use because payers will not pay for and patients will not attend prolonged hospital or clinic-based treatment regimens. There is good evidence from patients with renal failure on dialysis that more frequent, short-duration treatment sessions improve clinical outcomes and that may be true of many therapies delivered by complex devices.
In order to obtain labelling that allows use of a complex device or a diagnostic in the home, clinical data need to be obtained that demonstrate that patients of different ages, with different education and professional backgrounds, and different physical abilities (the so-called human factors), can all use the device or diagnostic successfully in the intended setting (the home). Setting up and managing clinical trials in patients' homes is very challenging but not impossible. In this audio conference, Dr. Helen Colquhoun describes these challenges and how best to meet them, using liberal examples.
Thursday, May 6, 2010
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.
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.
Wednesday, May 5, 2010
Start-Up Strategies for Medical Device Trials
is being presented by Amy Wise, Clinical Research Manager, with PharmaNet Development Group and airs on Wednesday, June 16th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com
The start-up phase of any clinical trial is a hectic time, but there are several areas that require additional consideration and planning for medical device trials. The primary goals of the start-up phase are to distribute and collect documentation to approve each site for the initiation visit so enrollment can begin. However, additonal support and planning is needed by sponsors/CROs for device trials to assist sites with specific tasks such as medicare approval; device shipment, storage, and accountability; planning for maintenance of a blind; and documentation of staff training on the investigational device.
This audio conference discusses how proactive planning and timely responsiveness to site requests can help make the start-up phase for medical device studies more efficient, and can lay the foundation for a positive relationship with the sites that will continue through the life of the study.
The start-up phase of any clinical trial is a hectic time, but there are several areas that require additional consideration and planning for medical device trials. The primary goals of the start-up phase are to distribute and collect documentation to approve each site for the initiation visit so enrollment can begin. However, additonal support and planning is needed by sponsors/CROs for device trials to assist sites with specific tasks such as medicare approval; device shipment, storage, and accountability; planning for maintenance of a blind; and documentation of staff training on the investigational device.
This audio conference discusses how proactive planning and timely responsiveness to site requests can help make the start-up phase for medical device studies more efficient, and can lay the foundation for a positive relationship with the sites that will continue through the life of the study.
Tuesday, May 4, 2010
A Unified Approach to Complaints, Servicing, and FDA Reporting
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Tuesday, June 8th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
The FDA continues to focus on post-market surveillance, and one of the leading causes of Warning Letters is failure to implement an effective system to manage complaints. In addition, complaints can lead to MDRs, corrections, and removals. Warning Letters often cite implementation failures, or even no implementation, of these other systems. One reason that firms do a poor job is that these essential systems are not in Part 820, the Quality System Regulation, and are often misunderstood or ignored.
This presentation provides practical advice on the FDA requirements for complaints, but expands the traditional scope to include closely linked, but often overlooked processes. We explore the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. For Servicing, our speaker explains the requirements to analyze service reports, shows how service reports can trigger MDRs, and automatically become complaints. The presentation reduces the regulatory language to simple English and explains how you can implement an effective and unified system.
The FDA regulations require three sets of documents: written procedures, records of activities, and reports to the FDA. This presentation explains the requirements in the multiple systems (complaint management, corrective actions, service management, risk management, and field upgrades) the manufacturer must implement.
The FDA continues to focus on post-market surveillance, and one of the leading causes of Warning Letters is failure to implement an effective system to manage complaints. In addition, complaints can lead to MDRs, corrections, and removals. Warning Letters often cite implementation failures, or even no implementation, of these other systems. One reason that firms do a poor job is that these essential systems are not in Part 820, the Quality System Regulation, and are often misunderstood or ignored.
This presentation provides practical advice on the FDA requirements for complaints, but expands the traditional scope to include closely linked, but often overlooked processes. We explore the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. For Servicing, our speaker explains the requirements to analyze service reports, shows how service reports can trigger MDRs, and automatically become complaints. The presentation reduces the regulatory language to simple English and explains how you can implement an effective and unified system.
The FDA regulations require three sets of documents: written procedures, records of activities, and reports to the FDA. This presentation explains the requirements in the multiple systems (complaint management, corrective actions, service management, risk management, and field upgrades) the manufacturer must implement.
Monday, May 3, 2010
Bridging the Linguistic Quality Gap: How to Measurably Improve Translation Quality
is being presented by Sonia Monahan, Executive Vice President of Quality Systems, with ForeignExchange Translations and airs Tuesday, June 1st, 2010. For more details or to register, please visit our site at www.fxconferences.com
A cornerstone of the translation industry is the quality of the linguistic work completed, yet linguistic quality remains nebulous for many end clients and translation suppliers. Linguistic quality means different things to different organizations and for different types of projects. With lack of measurable quality systems comes the need to add steps to the process to “ensure” quality. This perceived increase in quality (more people looking at the text) results in slower time-to-market and increased costs.
This audio conference looks at how to move from an uncertain quality outcome to measurable, predictable quality, while presenting an approach to defining, measuring and improving linguistic quality within an organization. The speaker also discusses how to utilize these measurements to meet the organization’s business objectives on a broader scale, spanning improvements in cost and time-to-market.
A cornerstone of the translation industry is the quality of the linguistic work completed, yet linguistic quality remains nebulous for many end clients and translation suppliers. Linguistic quality means different things to different organizations and for different types of projects. With lack of measurable quality systems comes the need to add steps to the process to “ensure” quality. This perceived increase in quality (more people looking at the text) results in slower time-to-market and increased costs.
This audio conference looks at how to move from an uncertain quality outcome to measurable, predictable quality, while presenting an approach to defining, measuring and improving linguistic quality within an organization. The speaker also discusses how to utilize these measurements to meet the organization’s business objectives on a broader scale, spanning improvements in cost and time-to-market.
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