is being presented by Steven Walfish, Statistician, with GE Healthcare and airs on Wednesday, April 4th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process for medical devices to ensure that the completed design that is transferred to production is appropriate for its intended use. The goal of this presentation is to understand the requirements and statistical techniques involved in the design controls process.
This audio conference looks at the types of requirements that lend themselves to statistics in verification and validation. Our speaker also covers the relationship between risk and sample size. Participants gain a fundamental knowledge for determining sample size in statistical testing, while understanding how variance in the population can impact the sample size necessary to establish objective evidence.
Friday, March 30, 2012
Thursday, March 29, 2012
Avoiding and Responding to FDA Import Alerts
is being presented by Lisa Capote, Partner, with Arrastia & Capote LLP and airs on Tuesday, April 3rd, 2012. For more details, or to register please visit our site at www.fxconferences.com
When companies, products or geographical regions are added to import alerts, also known as detention without physical examination, you can rest assured you are not getting through the US border without some additional effort on your part. At the point in time one of your products is listed on an import alert the product is automatically detained by FDA with assistance of Customs and Border Protection and it is your obligation to convince FDA that your product complies with the regulations. If the evidence you provide FDA is insufficient to merit release, the product will be refused entry. The process of having the product detained while you plead with FDA for a release can result in increased costs to the importer.
This audio conference presentation provides detail on FDA’s import alert process, and looks at the factors that result in facilities or their products being placed on import alert. Our speaker shares insight on proactive steps you can take to avoid this “blacklist” as well as some best practices to follow to be removed from import alert.
When companies, products or geographical regions are added to import alerts, also known as detention without physical examination, you can rest assured you are not getting through the US border without some additional effort on your part. At the point in time one of your products is listed on an import alert the product is automatically detained by FDA with assistance of Customs and Border Protection and it is your obligation to convince FDA that your product complies with the regulations. If the evidence you provide FDA is insufficient to merit release, the product will be refused entry. The process of having the product detained while you plead with FDA for a release can result in increased costs to the importer.
This audio conference presentation provides detail on FDA’s import alert process, and looks at the factors that result in facilities or their products being placed on import alert. Our speaker shares insight on proactive steps you can take to avoid this “blacklist” as well as some best practices to follow to be removed from import alert.
Monday, March 26, 2012
Human Subject Protection Programs - Analyzing the New Proposed Regulations
is being presented by Eric Allen, Director, Office of Research Compliance, with University of North Carolina at Greensboro and airs on Thursday, March 29th, 2012. For more details, or to register please visit our site at www.fxconferences.com
For the first time in more than 20 years, the Office of Human Research Protections is reviewing the federal regulations governing protection of human subjects. It will be the first substantive change to these regulations since 1991, and the potential impact will affect all individuals who are currently involved in human subject research and those who plan to be in the future.
Overall, this is a much-needed document for the human subject research community. There are a few areas in particular that will be improved by this new legislation, such as regularly updated expedited review categories and improved accountability for research as a whole. However, the majority of the changes provide great concern for investigators, IRBs, institutional officials, potential research subjects, and regulatory compliance administrators, as the revisions will drastically alter the way research is conducted, reviewed, and perceived by the general public.
In this audio conference presentation, our speaker analyzes the newly proposed human subject regulations in the context of their current state, highlighting significant changes and pointing out critical concerns and areas that need further clarification.
For the first time in more than 20 years, the Office of Human Research Protections is reviewing the federal regulations governing protection of human subjects. It will be the first substantive change to these regulations since 1991, and the potential impact will affect all individuals who are currently involved in human subject research and those who plan to be in the future.
Overall, this is a much-needed document for the human subject research community. There are a few areas in particular that will be improved by this new legislation, such as regularly updated expedited review categories and improved accountability for research as a whole. However, the majority of the changes provide great concern for investigators, IRBs, institutional officials, potential research subjects, and regulatory compliance administrators, as the revisions will drastically alter the way research is conducted, reviewed, and perceived by the general public.
In this audio conference presentation, our speaker analyzes the newly proposed human subject regulations in the context of their current state, highlighting significant changes and pointing out critical concerns and areas that need further clarification.
Friday, March 23, 2012
eLabeling Medical Devices for the EU Market
is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Wednesday, March 28th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Tuesday, March 20, 2012
Establishing Effective and FDA-Compliant Good Clinical Practices (GCP)
is being presented by Dr. David Lim, Founder, of Regulatory Doctor and airs on Tuesday, March 27th, 2012. For more details, or to register please visit our site at www.fxconferences.com
In the United States, scientific studies designed to develop evidence to support the safety and effectiveness of investigational drugs, biological products and medical devices (including in vitro diagnostic devices) are regulated by the Food and Drug Administration (FDA). Those conducting these clinical studies – such as clinical investigators, sponsors, monitors, and CROs – must comply with the applicable statutes and regulations governing good clinical practice (GCP).
This audio conference presentation is intended to provide attendees with a detailed review and understanding of the FDA regulations applicable for clinical trials or studies, and requirements for compliance. Our speaker drawns upon extensive industry experience and shares insight on the various aspects of GCP, empowering attendees with the key information they need regarding FDA regulations and requirements.
In the United States, scientific studies designed to develop evidence to support the safety and effectiveness of investigational drugs, biological products and medical devices (including in vitro diagnostic devices) are regulated by the Food and Drug Administration (FDA). Those conducting these clinical studies – such as clinical investigators, sponsors, monitors, and CROs – must comply with the applicable statutes and regulations governing good clinical practice (GCP).
This audio conference presentation is intended to provide attendees with a detailed review and understanding of the FDA regulations applicable for clinical trials or studies, and requirements for compliance. Our speaker drawns upon extensive industry experience and shares insight on the various aspects of GCP, empowering attendees with the key information they need regarding FDA regulations and requirements.
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