is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Tuesday, January 31st, 2012. For more details, or to register please visit our site at www.fxconferences.com
2011 was quite a year for publishing proposed major changes to the regulatory framework for medical device and diagnostics manufacturers. It is likely that more certainty will be introduced during 2012 as to what the changes will be and how they will affect MD&D companies. The major topics include the 510K process in the US, the planned recast of the Medical Device Directives in the EU, potential changes to the informed consent process for sample collection in the US, planned changes to the monitoring guidance in the US, and the changes to the ISO 14155 standard issued in 2011.
In this audio conference, our speaker reviews the changes or proposed changes to the regulatory framework, discusses the implications for MD&D companies, and describe how best to plan for future changes. The presentation also provides pointers on when the changes currently in draft form are likely to be implemented. This audio conference is intended to summarize the 2011 regulatory landscape for MD&D companies, and help them prepare for 2012 and beyond.
Friday, January 13, 2012
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.
Wednesday, January 4, 2012
Voice of the Customer: The First Step in Human Factors Engineering
is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Tuesday, January 17th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The medical device industry faces a unique challenge; R&D professionals develop products but rarely get a chance to use them, while quality departments lack the data to translate customer needs and marketing specifications into technical requirements and metrics. To compound the issue, FDA will soon have its final HFE Guidance in place, and all device products and companies will have to comply.
Voice of the Customer (VOC) allows device manufacturers to immerse product design teams in the customer’s culture and environment, and this audio conference presentation looks at how to use the VOC process to collect and analyze customer data and integrate it into the design process. Attendees learn how to develop market surveys and other tools to assess the needs of customers, and how to define and categorize customer issues with products. Our speaker discusses the relationship between VOC and HFE principles, and shares critical techniques for new product and product improvement initiatives.
The medical device industry faces a unique challenge; R&D professionals develop products but rarely get a chance to use them, while quality departments lack the data to translate customer needs and marketing specifications into technical requirements and metrics. To compound the issue, FDA will soon have its final HFE Guidance in place, and all device products and companies will have to comply.
Voice of the Customer (VOC) allows device manufacturers to immerse product design teams in the customer’s culture and environment, and this audio conference presentation looks at how to use the VOC process to collect and analyze customer data and integrate it into the design process. Attendees learn how to develop market surveys and other tools to assess the needs of customers, and how to define and categorize customer issues with products. Our speaker discusses the relationship between VOC and HFE principles, and shares critical techniques for new product and product improvement initiatives.
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