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 Other documents, such as the draft guidance FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, which explains all possible decision outcomes of an IDE submission, provide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.
Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts
Tuesday, April 24, 2012
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.
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.
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 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.
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.
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.
Wednesday, March 14, 2012
Monitoring Essentials for Medical Device Trials
is being presented by Helen Colquhoun, CEO, Pleiad Inc. and airs on Wednesday, March 21st, 2012. For more details, or to register please visit our site at www.fxconferences.com
Within the past few months, both FDA and ISO have issued updated regulatory guidance relevant to the monitoring of medical device trials. The FDA issued its draft guidance in August 2011, recommending a risk-based approach to monitoring. Meantime, the latest version of the ISO 14155 standard was also issued in 2011. It describes Good Clinical Practice for medical device trials, and it is an international standard, accepted in most countries. It includes guidance on monitoring and, ironically, leans towards a high proportion of on-site monitoring visits to assure data quality.
In this presentation, Dr. Helen Colquhoun provides an overview of the two guidance documents, and shares best practices for monitoring medical device trials. The presentation includes examples of citations in FDA warning letters for failure to monitor medical device studies correctly, in order to identify some common pitfalls during monitoring.
Within the past few months, both FDA and ISO have issued updated regulatory guidance relevant to the monitoring of medical device trials. The FDA issued its draft guidance in August 2011, recommending a risk-based approach to monitoring. Meantime, the latest version of the ISO 14155 standard was also issued in 2011. It describes Good Clinical Practice for medical device trials, and it is an international standard, accepted in most countries. It includes guidance on monitoring and, ironically, leans towards a high proportion of on-site monitoring visits to assure data quality.
In this presentation, Dr. Helen Colquhoun provides an overview of the two guidance documents, and shares best practices for monitoring medical device trials. The presentation includes examples of citations in FDA warning letters for failure to monitor medical device studies correctly, in order to identify some common pitfalls during monitoring.
Thursday, March 1, 2012
Post-market Design Changes – What FDA is Saying Now
is being presented by David Rothkopf, President, of MEDIcept and airs on Tuesday, March 13th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Many companies make subtle changes to their devices over time. However, those subtle changes can add up to the point where the current design no longer matches the product deemed safe and effective by the FDA. Whether you just received clearance for your product or it was last cleared in the last century, the FDA has stepped up enforcement on modifications to devices without notification. During site investigations, the FDA is looking at design changes and reviewing all the changes between now and when you last received a 510(k) clearance.
In July 2011 the FDA released a draft guidance document on 510(k) device modification and when to submit a new 510(k) for an existing device. This document reflects the current thinking of the FDA, and will replace the present guidance released in 1997. Are you ready? Do you know the configuration of your product when it was last cleared? Those “letter to file” changes might no longer be acceptable. This audio conference presentation reviews the new guidance document, looks at how to perform a design gap analysis on a device, and discusses what to do when you realize you probably should submit a new 510(k).
Many companies make subtle changes to their devices over time. However, those subtle changes can add up to the point where the current design no longer matches the product deemed safe and effective by the FDA. Whether you just received clearance for your product or it was last cleared in the last century, the FDA has stepped up enforcement on modifications to devices without notification. During site investigations, the FDA is looking at design changes and reviewing all the changes between now and when you last received a 510(k) clearance.
In July 2011 the FDA released a draft guidance document on 510(k) device modification and when to submit a new 510(k) for an existing device. This document reflects the current thinking of the FDA, and will replace the present guidance released in 1997. Are you ready? Do you know the configuration of your product when it was last cleared? Those “letter to file” changes might no longer be acceptable. This audio conference presentation reviews the new guidance document, looks at how to perform a design gap analysis on a device, and discusses what to do when you realize you probably should submit a new 510(k).
Monday, February 27, 2012
FDA Update – Responding to Unsolicited Requests for Off-Label Information
is being presented by Marian J. Lee & Dr. Beverly H. Lorell, Partner & Senior Medical and Policy Advisor, with King & Spalding LLP and airs on Thursday, March 8th, 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.
Monday, February 13, 2012
An Overview of Recent Risk-based Monitoring Guidance from the FDA
is being presented by Dr. Joy Frestedt, Frestedt Incorporated and airs on Wednesday, February 29th, 2012. For more details, or to register please visit our site at www.fxconferences.com
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
Wednesday, February 8, 2012
Measuring and Improving the Readability of Medical Device User Information
is being presented by Cynthia M. Shalers, Writing, Editing & Design Consultant and airs on Tuesday, February 28th, 2012. For more details or to register, please visit our site at www.fxconferences.com
A concise, clearly written, readable user guide can mean the difference between a successful, happy customer and a frustrated, angry, or even endangered one. This audio conference approaches readability in medical-device documentation from two directions. First, our speaker explains how to achieve the reading level required by the FDA, providing attendees with the tools for measuring the reading level and adjusting it editorially. Second, she offers a variety of methods for increasing conciseness and simplicity in medical writing, which can be applied to any level of complexity to improve readability. The presentation also reviews graphical aspects that improve readability, such as the proper use of white space, leading, lists, and sidebars. Throughout the conference, the speaker uses specific examples from her own work and cites the relevant FDA guidance documents.
A concise, clearly written, readable user guide can mean the difference between a successful, happy customer and a frustrated, angry, or even endangered one. This audio conference approaches readability in medical-device documentation from two directions. First, our speaker explains how to achieve the reading level required by the FDA, providing attendees with the tools for measuring the reading level and adjusting it editorially. Second, she offers a variety of methods for increasing conciseness and simplicity in medical writing, which can be applied to any level of complexity to improve readability. The presentation also reviews graphical aspects that improve readability, such as the proper use of white space, leading, lists, and sidebars. Throughout the conference, the speaker uses specific examples from her own work and cites the relevant FDA guidance documents.
Monday, February 6, 2012
Food Industry Update – Responding to an FDA Form 483
is being presented by Lisa Capote, Partner, with Arrastia & Capote LLP and airs on Thursday, February 23rd, 2012. For more details or to register, please visit our site at www.fxconferences.com
On January 4, 2011 President Obama signed into law the FDA Food Safety Modernization Act (FSMA). As part of the new regulation, FDA will provide oversight, ensure compliance with requirements and respond effectively when problems emerge. The FSMA mandates inspection frequency based on risk for food facilities, and requires the frequency of inspections to increase immediately. The law directs FDA to inspect at least 600 foreign food facilities within one year of enactment, and double those inspections every year for the next five years. Odds are, that will in turn lead to the issuance of a great deal of additional Form 483s to companies that have never before seen one, let alone had to respond to one.
This audio conference presentation provides detail on the FDA's plans for increased facility inspections, and looks at the most likely areas of scrutiny for inspectors in the coming months. Our speaker shares insight on the steps you can take to ensure a successful inspection, and, in the event your company receives a Form 483, how best to respond so as to avoid a re-inspection.
On January 4, 2011 President Obama signed into law the FDA Food Safety Modernization Act (FSMA). As part of the new regulation, FDA will provide oversight, ensure compliance with requirements and respond effectively when problems emerge. The FSMA mandates inspection frequency based on risk for food facilities, and requires the frequency of inspections to increase immediately. The law directs FDA to inspect at least 600 foreign food facilities within one year of enactment, and double those inspections every year for the next five years. Odds are, that will in turn lead to the issuance of a great deal of additional Form 483s to companies that have never before seen one, let alone had to respond to one.
This audio conference presentation provides detail on the FDA's plans for increased facility inspections, and looks at the most likely areas of scrutiny for inspectors in the coming months. Our speaker shares insight on the steps you can take to ensure a successful inspection, and, in the event your company receives a Form 483, how best to respond so as to avoid a re-inspection.
Monday, January 30, 2012
The De Novo Petition – Is There Hope at FDA for Lower Risk, Innovative Devices?
is being presented by Michael A. Swit, Principal, with Law Offices of Michael A. Swit and airs on Wednesday, February 15th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The 'de novo' 510(k) petition process presents a unique opportunity for medical device companies to bring products to the market without having to go through the more lengthy and expensive route of a Premarket Approval Application (PMA).
In 1997, recognizing that many innovative devices put into Class III presented lower risks, Congress revised the medical device laws to create the de novo petition. It allows a company to petition FDA to move a device that has been automatically classified into Class III to Class II or even Class I. While designed to relieve the regulatory burden on industry, the de novo petition process has presented many challenges. Less than 70 devices have successfully undergone the de novo process. And, the process is not easy. Before pursuing a petition, a firm must first file a 510(k) and have FDA deny the submission as not substantially equivalent.
In late 2011, FDA issued a new draft guidance on the de novo process, and legislation is pending that would streamline the system. This audio conference explores how to take advantage of the de novo process, challenges linked to the process and how to best position your petition for success.
The 'de novo' 510(k) petition process presents a unique opportunity for medical device companies to bring products to the market without having to go through the more lengthy and expensive route of a Premarket Approval Application (PMA).
In 1997, recognizing that many innovative devices put into Class III presented lower risks, Congress revised the medical device laws to create the de novo petition. It allows a company to petition FDA to move a device that has been automatically classified into Class III to Class II or even Class I. While designed to relieve the regulatory burden on industry, the de novo petition process has presented many challenges. Less than 70 devices have successfully undergone the de novo process. And, the process is not easy. Before pursuing a petition, a firm must first file a 510(k) and have FDA deny the submission as not substantially equivalent.
In late 2011, FDA issued a new draft guidance on the de novo process, and legislation is pending that would streamline the system. This audio conference explores how to take advantage of the de novo process, challenges linked to the process and how to best position your petition for success.
Friday, January 27, 2012
The Food Safety Modernization Act – What It Really Means (And What It Doesn't)
is being presented by Benjamin L England, Founder and CEO, of FDAImports.com and airs on Wednesday, February 15th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Since its introduction, the Food Safety Modernization Act has been discussed, written about and portrayed ad infinitum, often out of any sensible context to the actual realities of importing and manufacturing. Hyperbole aside, what does it really mean for you and your company?
With this timely audio conference presentation, former FDA veteran Benjamin England brings a much-needed reality check to the FSMA conversation. The presentation looks at what FSMA implementation this year will likely consist of, and what specific issues are likely to arise based on these new rules in a real-world context. For manufacturers, companies and distributors this means valuable insight into which changes should be of concern, what can safely be ignored, what they can expect in the coming months, and how best to prepare. Mr. England devotes special attention to the implementation dates for 2012, and provides attendees with an opportunity to ask questions specific to their situation.
Since its introduction, the Food Safety Modernization Act has been discussed, written about and portrayed ad infinitum, often out of any sensible context to the actual realities of importing and manufacturing. Hyperbole aside, what does it really mean for you and your company?
With this timely audio conference presentation, former FDA veteran Benjamin England brings a much-needed reality check to the FSMA conversation. The presentation looks at what FSMA implementation this year will likely consist of, and what specific issues are likely to arise based on these new rules in a real-world context. For manufacturers, companies and distributors this means valuable insight into which changes should be of concern, what can safely be ignored, what they can expect in the coming months, and how best to prepare. Mr. England devotes special attention to the implementation dates for 2012, and provides attendees with an opportunity to ask questions specific to their situation.
Monday, January 16, 2012
7 Critical FDA Expectations of Senior Management
is being presented by John Avellanet, Managing Director & Principal, with Cerulean Associates LLC and airs on Tuesday, January 31st, 2012. For more details or to register, please visit our site at www.fxconferences.com
The FDA is cracking down on corporate executives, using the Park Doctrine and the FDAAA to impose civil penalties, jail time and industry bans.
This audio conference presentation focuses on the things your management team needs to be doing on a regular, consistent basis to 'ensure the suitability and effectiveness' of your company's quality system. Our speaker, who is president of an independent review organization (IRO) for a current consent decree, provides insight on what FDA investigators and district officers expect to see from your management team. Attendees discover the crucial difference in the eyes of FDA between responsibility and accountability, and how it affects delegating work to staff and suppliers. The presentation also discusses how to ensure your management team is effectively and appropriately engaged, and what proof you need to provide the agency investigators.
The FDA is cracking down on corporate executives, using the Park Doctrine and the FDAAA to impose civil penalties, jail time and industry bans.
This audio conference presentation focuses on the things your management team needs to be doing on a regular, consistent basis to 'ensure the suitability and effectiveness' of your company's quality system. Our speaker, who is president of an independent review organization (IRO) for a current consent decree, provides insight on what FDA investigators and district officers expect to see from your management team. Attendees discover the crucial difference in the eyes of FDA between responsibility and accountability, and how it affects delegating work to staff and suppliers. The presentation also discusses how to ensure your management team is effectively and appropriately engaged, and what proof you need to provide the agency investigators.
Tuesday, January 10, 2012
Food Defense – Regulatory Requirements and New Developments
is being presented by William L Ramsey, Director of Security, with McCormick & Company and airs on Thursday, January 26th, 2012. For more details or to register, please visit our site at www.fxconferences.com
The safety and security of the food supply has come under intense scrutiny in the wake of 9/11. In the intervening years "food defense" has become an industry catchphrase. But what exactly does it mean? What do regulators want to see?
This audio conference presentation reviews the use of physical security practices in the food industry since the events of September 11, 2001 and the advent of the term “food defense”. Our speaker discusses current food defense expectations from both the USDA and FDA, and takes a look at some possible regulatory developments associated with the Food Safety Modernization Act of 2010.
The presentation provides key information on the use of threat assessments, vulnerability assessments and risk assessments, as well as the use of a “goal based” security model in the development of security and food defense plans for food manufacturing facilities. Attendees also learn about supply chain responsibilities, and ways to utilize national and international supply chain programs such as C-TPAT, AEO and PIP to enhance food defense measures.
The safety and security of the food supply has come under intense scrutiny in the wake of 9/11. In the intervening years "food defense" has become an industry catchphrase. But what exactly does it mean? What do regulators want to see?
This audio conference presentation reviews the use of physical security practices in the food industry since the events of September 11, 2001 and the advent of the term “food defense”. Our speaker discusses current food defense expectations from both the USDA and FDA, and takes a look at some possible regulatory developments associated with the Food Safety Modernization Act of 2010.
The presentation provides key information on the use of threat assessments, vulnerability assessments and risk assessments, as well as the use of a “goal based” security model in the development of security and food defense plans for food manufacturing facilities. Attendees also learn about supply chain responsibilities, and ways to utilize national and international supply chain programs such as C-TPAT, AEO and PIP to enhance food defense measures.
Monday, January 9, 2012
An Overview of Recent Risk-based Monitoring Guidance from the FDA
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, January 25th, 2012. For more details, or to register please visit our site at www.fxconferences.com
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
Friday, January 6, 2012
Collecting Post-Market Device Data Without Running Afoul of FDA
is being presented by Robert J. Klepinski, Regulatory Attorney, with Fredrikson & Byron and airs on Thursday, January 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Most medical device companies today wish to gather data on product use and performance without being entangled in expensive IDE negotiations. However, recent FDA enforcement actions have brought new scrutiny to post-market studies. FDA has combined accusations of off-label promotion with enforcement against studies collecting data on usage deemed to be outside cleared labeling. So what are device manufacturers to do? Is there still a path available for collecting this important information? This audio conference explores the regulations involved, recent enforcement actions by FDA, the difficulties in ascertaining the scope of indications today, and ways to gather information within the current enforcement environment.
Most medical device companies today wish to gather data on product use and performance without being entangled in expensive IDE negotiations. However, recent FDA enforcement actions have brought new scrutiny to post-market studies. FDA has combined accusations of off-label promotion with enforcement against studies collecting data on usage deemed to be outside cleared labeling. So what are device manufacturers to do? Is there still a path available for collecting this important information? This audio conference explores the regulations involved, recent enforcement actions by FDA, the difficulties in ascertaining the scope of indications today, and ways to gather information within the current enforcement environment.
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