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 www.fxconferences.com
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 23, 2012
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 http://www.fxconferences.com/Implementing-the-FDA-Guidance-on-Investigator-Responsibility-P1009.aspx
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.
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 www.fxconferences.com
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.
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 www.fxconferences.com
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.
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 www.fxconferences.com
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.
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.
Tuesday, May 8, 2012
Dollars and Sense – The Cost of Quality (COQ) Model and the Bottom Line
is being presented by Rene D. Massengale, President, of Global Food
Quality Concepts, LLC and airs on Wednesday, May 16th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The food and beverage industry is faced with increasing pressure to improve the safety and quality of products for human consumption while still maintaining a profitable bottom line. Successful companies understand that quality management is vital to successfully meeting this challenge, but how does the cost of quality affect the bottom line?
Cost of Quality is defined as the cost associated with detecting and avoiding quality failures. It is the cost associated with monitoring, detecting, and correcting errors in manufacturing or personnel. A Cost of Quality model is a quality management tool that can be integrated into other quality management systems to better understand and track the cost of quality failure over time. It translates the language of quality into the language of dollars understood by senior management.
This audio conference presentation explores quality costs, the Cost of Quality (COQ) model, and how it can be used to measure the real benefit derived from quality management efforts. In addition, our speaker discusses how Cost of Quality can be used to track the impact of quality compliance and noncompliance on the organization’s revenues from a risk management perspective.
The food and beverage industry is faced with increasing pressure to improve the safety and quality of products for human consumption while still maintaining a profitable bottom line. Successful companies understand that quality management is vital to successfully meeting this challenge, but how does the cost of quality affect the bottom line?
Cost of Quality is defined as the cost associated with detecting and avoiding quality failures. It is the cost associated with monitoring, detecting, and correcting errors in manufacturing or personnel. A Cost of Quality model is a quality management tool that can be integrated into other quality management systems to better understand and track the cost of quality failure over time. It translates the language of quality into the language of dollars understood by senior management.
This audio conference presentation explores quality costs, the Cost of Quality (COQ) model, and how it can be used to measure the real benefit derived from quality management efforts. In addition, our speaker discusses how Cost of Quality can be used to track the impact of quality compliance and noncompliance on the organization’s revenues from a risk management perspective.
Thursday, May 3, 2012
Industry Update – Europe's New Pharmacovigilance Regulations
is being presented by Dr. Ulrich Granzer, President, Granzer
Regulatory Consulting & Services and airs on Tuesday, May 15th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The EU parliament and the EU Council have issued a new pharmacovigilance regulation, which will come into force in July. The legislation defines new and additional tasks and responsibilities for the Coordination Group, defines a new “urgent union procedure” for pharmacovigilance, and also provides a definition for post authorization safety and efficacy studies and how these new tasks are to be performed. For this particular set of tasks a new body is being established, called PRAC, which will perform safety evaluations. Opinions of the PRAC will then be adopted by the EMA or, in the case of older or national registrations, the Coordination Group for the Decentralized and the Mutual recognition procedure, the CMDh. This new system will be in charge of all critical pharmacovigilance items and issues.
In this audio conference presentation, our speaker discusses these new changes to the EU pharmacovigilance rules, as well as potential critical issues arising from the EU’s complexity and decision-making process.
The EU parliament and the EU Council have issued a new pharmacovigilance regulation, which will come into force in July. The legislation defines new and additional tasks and responsibilities for the Coordination Group, defines a new “urgent union procedure” for pharmacovigilance, and also provides a definition for post authorization safety and efficacy studies and how these new tasks are to be performed. For this particular set of tasks a new body is being established, called PRAC, which will perform safety evaluations. Opinions of the PRAC will then be adopted by the EMA or, in the case of older or national registrations, the Coordination Group for the Decentralized and the Mutual recognition procedure, the CMDh. This new system will be in charge of all critical pharmacovigilance items and issues.
In this audio conference presentation, our speaker discusses these new changes to the EU pharmacovigilance rules, as well as potential critical issues arising from the EU’s complexity and decision-making process.
Wednesday, May 2, 2012
HFE Usability Testing: Medical Device Industry Panel
is being presented by Maria Shepherd & Kathleen
Whanger, President & Senior Quality Engineer, with Data Decision Group & Boston Scientific and airs on Thursday, May 10th, 2012. For more details or to register, please visit our site at www.fxconferences.com
The Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design was released by the FDA in June, 2011. It states that, as part of design control, manufacturers must conduct a risk analysis to assess/mitigate risks associated with device use. In addition, the FDA expects the manufacturer will perform human factors engineering and usability testing as a part of the product development process.
FDA takes these human factors requirements seriously, requiring a systematic assessment that incorporates usability testing to determine how the device will be used, the environment in which it will be used, and existing use-related hazards. Under these circumstances, manufacturers should provide FDA with a report that summarizes the human factors processes, evaluations, and results of validation testing as part of their pre-market applications or submission.
The Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design was released by the FDA in June, 2011. It states that, as part of design control, manufacturers must conduct a risk analysis to assess/mitigate risks associated with device use. In addition, the FDA expects the manufacturer will perform human factors engineering and usability testing as a part of the product development process.
FDA takes these human factors requirements seriously, requiring a systematic assessment that incorporates usability testing to determine how the device will be used, the environment in which it will be used, and existing use-related hazards. Under these circumstances, manufacturers should provide FDA with a report that summarizes the human factors processes, evaluations, and results of validation testing as part of their pre-market applications or submission.
Tuesday, May 1, 2012
Meeting the Linguistic Requirements for EMA Submissions
is being presented by Anabel Pérez, Senior Project Manager, with ForeignExchange Translations and airs on Wednesday, May 9th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.
In this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.
Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.
In this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.
Wednesday, April 25, 2012
From Site to Sample: Considerations for Effective Minimal Risk Diagnostic Research
is being presented by Kathleen Mandziuk & Cathy Michael, Scientific Affairs Director & Senior Director of Comprehensive Solutions, with PRA & BioStorage Technologies and airs on Thursday, May 3rd, 2012. For more details or to register, please visit our site at www.fxconferences.com
*PRA is sponsoring this event, making it complimentary for all registered attendees. Please register for this event, and submit complete attendee information once you've registered, so we can assure you a space in the webinar. Incomplete registrations will not be honored. Please register each line for your group separately.*
Webinar highlights
The exponential increase of discovery, validation and commercialization of diagnostic and companion biomarkers has lead to a greater need for effective, efficient and proven research methods. Many industry experts focus on processing biological samples – however, what happens beforehand to ensure high-quality samples and data is collected?.
This educational webinar will focus on the evolving space of biomarker research and established techniques for cost-effective high-quality execution strategies. The speaker will cover a wide variety of topics from various industry perspectives.
*PRA is sponsoring this event, making it complimentary for all registered attendees. Please register for this event, and submit complete attendee information once you've registered, so we can assure you a space in the webinar. Incomplete registrations will not be honored. Please register each line for your group separately.*
Webinar highlights
The exponential increase of discovery, validation and commercialization of diagnostic and companion biomarkers has lead to a greater need for effective, efficient and proven research methods. Many industry experts focus on processing biological samples – however, what happens beforehand to ensure high-quality samples and data is collected?.
This educational webinar will focus on the evolving space of biomarker research and established techniques for cost-effective high-quality execution strategies. The speaker will cover a wide variety of topics from various industry perspectives.
Tuesday, April 24, 2012
What's New with Investigational Device Exemptions (IDE)?
is being presented by Cheryl Hill, Regulatory Manager, with Pleiad Inc. and airs on Wednesday, May 2nd, 2012. For more details or to register, please visit our site at www.fxconferences.com
Is the IDE program changing? Over the past 12 months FDA has released several proposed rules, final rules, draft guidances and final guidance documents. Some of these documents have an immediate impact on the IDE program, such as the final rule regarding Informed Consent Elements. This rule mandates that for all applicable device (or drug/biologic) clinical trials, informed consent documents and processes include a specific statement that the clinical trial information will be entered into a databank – with a compliance date of March 2012. Other documents, such as the draft guidance FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, which explains all possible decision outcomes of an IDE submission, provide insight into the IDE program and Agency expectations.
This audio conference presentation provides an overview of these documents, as our speaker explains their impact on IDE regulations and offers suggestions for compliance.
Is the IDE program changing? Over the past 12 months FDA has released several proposed rules, final rules, draft guidances and final guidance documents. Some of these documents have an immediate impact on the IDE program, such as the final rule regarding Informed Consent Elements. This rule mandates that for all applicable device (or drug/biologic) clinical trials, informed consent documents and processes include a specific statement that the clinical trial information will be entered into a databank – with a compliance date of March 2012. Other documents, such as the draft guidance FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, which explains all possible decision outcomes of an IDE submission, provide insight into the IDE program and Agency expectations.
This audio conference presentation provides an overview of these documents, as our speaker explains their impact on IDE regulations and offers suggestions for compliance.
Monday, April 23, 2012
FSMA and Traceability – Complying With FDA's New Requirements
is being presented by Pamela Sweeten, Principal, of P. Sweeten Consulting and airs on Tuesday, May 1st, 2012. For more details or to register, please visit our site at www.fxconferences.com
Under the traceability provisions of the Food Safety Modernization Act, food producers, manufacturers and distributors must be able to provide FDA with all of the data necessary data to facilitate a product recall with as little as four hours notice. So what does this mean in practical terms? How should your company go about capturing and storing all that data?
This timely audio conference presentation looks at what FDA will require from growers, packers, processors and shippers to accurately track processes, and what specific issues are likely to arise based on these new rules in a real-world context. Our speaker provides attendees with valuable insight into which changes should be of most concern, what they can expect in the coming months, and how best to prepare.
Under the traceability provisions of the Food Safety Modernization Act, food producers, manufacturers and distributors must be able to provide FDA with all of the data necessary data to facilitate a product recall with as little as four hours notice. So what does this mean in practical terms? How should your company go about capturing and storing all that data?
This timely audio conference presentation looks at what FDA will require from growers, packers, processors and shippers to accurately track processes, and what specific issues are likely to arise based on these new rules in a real-world context. Our speaker provides attendees with valuable insight into which changes should be of most concern, what they can expect in the coming months, and how best to prepare.
Friday, April 20, 2012
Managing Legal and PR Risks in Social Media
is being presented by Allison Fitzpatrick & Laura J. Protzmann, Partner & Counsel, of Davis & Gilbert LLP & The Dannon Company, Inc. and airs on Thursday, April 26th, 2012. For more details or to register, please visit our site at www.fxconferences.com
With the explosion of social media has come a significant increase in the level of regulatory scrutiny, making it imperative to put in place policies and practices compliant with applicable laws. This audio conference presentation discusses the rules that apply to social media, and what you need to do to comply with the law, including the FTC endorsement guides.
Our speakers also address the legal and PR issues that arise when marketers, their employees, bloggers, affiliates and spokespersons fail to comply with FTC endorsement guides. The presentation explains why it is so important to have a social media policy, and what should be included in that policy. Lastly, the speakers also discuss what rules apply when conducting a promotion using social media, including Facebook and Twitter.
With the explosion of social media has come a significant increase in the level of regulatory scrutiny, making it imperative to put in place policies and practices compliant with applicable laws. This audio conference presentation discusses the rules that apply to social media, and what you need to do to comply with the law, including the FTC endorsement guides.
Our speakers also address the legal and PR issues that arise when marketers, their employees, bloggers, affiliates and spokespersons fail to comply with FTC endorsement guides. The presentation explains why it is so important to have a social media policy, and what should be included in that policy. Lastly, the speakers also discuss what rules apply when conducting a promotion using social media, including Facebook and Twitter.
Thursday, April 19, 2012
The Foreign Supplier Verification Program and What It Means for the Food Industry
is being presented by Marc C. Sanchez, Regulatory Counsel, with Contract In-House Counsel and Consultants, LLC and airs on Wednesday, April 25th, 2012. For more details or to register, please visit our site at www.fxconferences.com
The Foreign Supplier Verification Program (FSVP) automatically takes effect in 2013 under the terms of the Food Safety Modernization Act. Congress had set a one-year deadline of January 4, 2012 for the FDA to publish details on how it will regulate imported foods. This includes verifying foreign suppliers, a definition of high-risk foods, and a certification process. While the FDA missed that deadline, it has promised a rule and guidelines soon.
In the meantime, the FSMA makes it clear that the foreign supplier verification program will become mandatory in 2013, whether a rule is in place or not. In this audio conference presentation, our speaker provides an overview of the FSVP, looks at the likely FDA definition of high-risk foods, and what is likely to be the certification process. The presentation also provides advice on how to cope with compliance when the FDA lags behind in rulemaking.
The Foreign Supplier Verification Program (FSVP) automatically takes effect in 2013 under the terms of the Food Safety Modernization Act. Congress had set a one-year deadline of January 4, 2012 for the FDA to publish details on how it will regulate imported foods. This includes verifying foreign suppliers, a definition of high-risk foods, and a certification process. While the FDA missed that deadline, it has promised a rule and guidelines soon.
In the meantime, the FSMA makes it clear that the foreign supplier verification program will become mandatory in 2013, whether a rule is in place or not. In this audio conference presentation, our speaker provides an overview of the FSVP, looks at the likely FDA definition of high-risk foods, and what is likely to be the certification process. The presentation also provides advice on how to cope with compliance when the FDA lags behind in rulemaking.
Wednesday, April 18, 2012
Medical Device Reimbursement in China
is being presented by Seth J. Goldenberg, President, of Asia Pacific Bio Intelligence and airs on Tuesday, April 24th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Medical device and pharmaceutical manufacturers have been facing increasing downward pressure on their products because of pricing regulations in China. It has become increasingly important to not only understand how to get your product through the regulatory approval process in China, but also how to get the price you want in China's rapidly evolving healthcare landscape.
This audio conference presentation provides attendees with an overview of the healthcare system in China, and how imported medical devices are viewed and treated under the Chinese insurance system. Our speaker discusses device reimbursement policies at the local and national levels, and reviews some recent developments in that regard.
Medical device and pharmaceutical manufacturers have been facing increasing downward pressure on their products because of pricing regulations in China. It has become increasingly important to not only understand how to get your product through the regulatory approval process in China, but also how to get the price you want in China's rapidly evolving healthcare landscape.
This audio conference presentation provides attendees with an overview of the healthcare system in China, and how imported medical devices are viewed and treated under the Chinese insurance system. Our speaker discusses device reimbursement policies at the local and national levels, and reviews some recent developments in that regard.
Monday, April 16, 2012
Agile Software Development in the Medical Device Industry
is being presented by Janet Balk, Principal, with Agile FDA and airs on Thursday, April 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Decreasing development timelines and getting products to market faster benefits both patients and health care providers and is obviously a priority for any company. However, when a medical device company embraces agile software development to accomplish this goal, there are common pitfalls that can be counter-productive and might actually delay getting your product out the door. What's more, introducing agile methodology can create tension between those working in quality, regulatory affairs and R&D. This audio conference presentation demonstrates how to avoid the most common pitfalls, how to ensure compliance with agile development, and how to strengthen the agile process and make it a win-win for departments with differing priorities.
Decreasing development timelines and getting products to market faster benefits both patients and health care providers and is obviously a priority for any company. However, when a medical device company embraces agile software development to accomplish this goal, there are common pitfalls that can be counter-productive and might actually delay getting your product out the door. What's more, introducing agile methodology can create tension between those working in quality, regulatory affairs and R&D. This audio conference presentation demonstrates how to avoid the most common pitfalls, how to ensure compliance with agile development, and how to strengthen the agile process and make it a win-win for departments with differing priorities.
Wednesday, April 11, 2012
Developing a Sampling Plan for Quality Audits
is being presented by Dan O’Leary, President, of Ombu Enterprises, LLC and airs on Thursday, April 19th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Quality audits typically involve sampling of records and other documents. When the auditor does this a lot of questions come up, such as how many records to sample and how many nonconforming records are too many. In fact, there is a more fundamental question about nonconforming records. If a record has, say, three errors does the auditor count it three times – once for each error – or just once, as a nonconforming record? Some auditors determine the sample size without using statistical techniques. Is this ever acceptable? Sampling records in an audit is not the same as sampling at incoming inspection; the underlying assumptions are different, so the methods need to change.
This audio conference examines the issues in audit sampling and provides the answers you need to plan your audit. Participants learn the difference between counting nonconformities and counting nonconformances and which techniques to apply in a quality audit. An audit may need to determine the error rate in a process, or least show that it is not too great. Attendees learn some standard sampling plans as well the reason they work. As an example, participants will analyze the sampling plans the FDA uses as part of the Quality System Technique (QSIT)
Quality audits typically involve sampling of records and other documents. When the auditor does this a lot of questions come up, such as how many records to sample and how many nonconforming records are too many. In fact, there is a more fundamental question about nonconforming records. If a record has, say, three errors does the auditor count it three times – once for each error – or just once, as a nonconforming record? Some auditors determine the sample size without using statistical techniques. Is this ever acceptable? Sampling records in an audit is not the same as sampling at incoming inspection; the underlying assumptions are different, so the methods need to change.
This audio conference examines the issues in audit sampling and provides the answers you need to plan your audit. Participants learn the difference between counting nonconformities and counting nonconformances and which techniques to apply in a quality audit. An audit may need to determine the error rate in a process, or least show that it is not too great. Attendees learn some standard sampling plans as well the reason they work. As an example, participants will analyze the sampling plans the FDA uses as part of the Quality System Technique (QSIT)
Monday, April 9, 2012
Investigator Brochures for Medical Devices
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, April 18th, 2012. For more details, or to register please visit our site at www.fxconferences.com
An investigator's brochure (IB) is required for compliance with the EU Medical Device Directives (e.g. 2.7.2) and also with ISO 14155: Clinical Investigations of Medical Devices in Human Subjects – Good Clinical Practices. The development of an IB for medical devices should reflect the engineering features of the device, in much the same way that an IB for pharmaceutical agents reflects the chemical features of the drug. As a dynamic document, the IB must be carefully constructed and, ideally, it should accurately represent the current state of all knowledge about the investigational product – including information about AEs, SAEs, and important manufacturing details as well as nonclinical and clinical study results.
This audio conference presentation provides an overview and best practices for the medical device IB, looking at some of the related issues specific to devices and discussing how the brochure is likely to evolve over time.
An investigator's brochure (IB) is required for compliance with the EU Medical Device Directives (e.g. 2.7.2) and also with ISO 14155: Clinical Investigations of Medical Devices in Human Subjects – Good Clinical Practices. The development of an IB for medical devices should reflect the engineering features of the device, in much the same way that an IB for pharmaceutical agents reflects the chemical features of the drug. As a dynamic document, the IB must be carefully constructed and, ideally, it should accurately represent the current state of all knowledge about the investigational product – including information about AEs, SAEs, and important manufacturing details as well as nonclinical and clinical study results.
This audio conference presentation provides an overview and best practices for the medical device IB, looking at some of the related issues specific to devices and discussing how the brochure is likely to evolve over time.
Tuesday, April 3, 2012
Best Practices for Conducting Clinical Trials in Emerging Countries
is being presented by Dr. Nermeen Varawalla, CEO, of ECCRO and airs on Tuesday, April 17th, 2012. For more details or to register, please visit our site at www.fxconferences.com
The value of emerging countries in delivering cost-effective patient recruitment is well documented. However concerns remain about data quality, GCP compliance, extrapolation of trial outcomes and regulatory hurdles. These concerns often can be addressed by combining an understanding of international clinical trial requirements and local expertise.
Our speaker for this event is Dr. Nermeen Varawalla, a reknowned expert on the conduct of clinical studies in emerging markets in general, and India in particular. In this presentation she discusses how to take things one step further by customizing industry best practices for the emerging clinical trial environment. These include the formation of select investigator networks, integrated site management and data-driven, hybrid monitoring. In this presentation, Dr. Varawalla shares case studies highlighting her work in India to illustrate the effectiveness of these practices in overcoming typical concerns about conducting clinical research in emerging countries.
The value of emerging countries in delivering cost-effective patient recruitment is well documented. However concerns remain about data quality, GCP compliance, extrapolation of trial outcomes and regulatory hurdles. These concerns often can be addressed by combining an understanding of international clinical trial requirements and local expertise.
Our speaker for this event is Dr. Nermeen Varawalla, a reknowned expert on the conduct of clinical studies in emerging markets in general, and India in particular. In this presentation she discusses how to take things one step further by customizing industry best practices for the emerging clinical trial environment. These include the formation of select investigator networks, integrated site management and data-driven, hybrid monitoring. In this presentation, Dr. Varawalla shares case studies highlighting her work in India to illustrate the effectiveness of these practices in overcoming typical concerns about conducting clinical research in emerging countries.
Monday, April 2, 2012
FDA Update – Responding to Unsolicited Requests for Off-Label Information
is being presented by Marian J. Lee & Beverly H. Lorell, Partner & Senior Advisor, with King & Spalding LLP and airs on Thursday, April 12th, 2012. For more details, or to register please visit our site at www.fxconferences.com
FDA recently released a significant draft guidance on how manufacturers and distributors of drugs and medical devices may respond to unsolicited requests for information about off-label uses of their products. This audio conference presentation analyzes the far-reaching implications of that new guidance for company practices and procedures regarding these scientific communications, and also what it means for the use of off-label promotion as the basis for enforcement action by FDA and other federal authorities. Our speakers examine the impact of the agency's newly defined distinctions between solicited and unsolicited requests for information, and non-public and public information requests, including those requests arising in emerging electronic media. The presentation focuses on providing practical tips and pitfalls to avoid in implementing this new draft guidance.
FDA recently released a significant draft guidance on how manufacturers and distributors of drugs and medical devices may respond to unsolicited requests for information about off-label uses of their products. This audio conference presentation analyzes the far-reaching implications of that new guidance for company practices and procedures regarding these scientific communications, and also what it means for the use of off-label promotion as the basis for enforcement action by FDA and other federal authorities. Our speakers examine the impact of the agency's newly defined distinctions between solicited and unsolicited requests for information, and non-public and public information requests, including those requests arising in emerging electronic media. The presentation focuses on providing practical tips and pitfalls to avoid in implementing this new draft guidance.
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