is being presented by Shawn K. Stevens, National Food Safety Lawyer, with Gass Weber Mullins LLC and airs on Thursday, August 18th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Anyone involved in the food industry has heard about the new Food Safety Modernization Act (FSMA). Enacted in January 2011, the FSMA makes sweeping changes to the way food products are manufactured, distributed and regulated.
Although the FSMA imposes many new requirements on the food industry, the one that will likely have the greatest impact is the requirement that, prior to June 2012, food companies adopt and implement written food safety plans. In regulatory and legal terms, this means that regulated food companies will be required to develop and then closely follow a hazard analysis and critical control point (HACCP) methodology. Thus, whether you import, process or distribute food products, the new legislation can and will substantially impact the nature of your business.
This audio conference provides attendees with an overview of the new FDA requirements, along with how and when FDA will likely begin enforcing them, and how best to prepare your business for the coming changes.
Wednesday, July 13, 2011
Monday, July 11, 2011
Section 1603 – Qualifying for 2011 & Planning for the Future
is being presented by Gregory F. Jenner, Partner, with Stoel Rives LLP and airs on Thursday, August 11th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The 1603 grant has been both a lifesaver and a game changer for the renewable energy sector. However, section 1603 is likely going the way of the dodo after 2011 unless construction has begun on a project before then. Therefore, it is imperative that developers and others understand how to meet the alternative tests for beginning construction. In addition, moving beyond 2011, the sunset of section 1603 will place increased emphasis on optimizing the use of tax equity and the various structures that are available.
This audio conference presentation focuses on qualifying for 1603 for the balance of 2011, and also reviews the available structures used to monetize tax incentives – including partnership flips, sale-leaseback transactions, leases with credit pass-through arrangements, and prepayment structures. Our speaker discusses the advantages and disadvantages of each, and provides attendees with insight and guidance to help them prepare for life after section 1603.
The 1603 grant has been both a lifesaver and a game changer for the renewable energy sector. However, section 1603 is likely going the way of the dodo after 2011 unless construction has begun on a project before then. Therefore, it is imperative that developers and others understand how to meet the alternative tests for beginning construction. In addition, moving beyond 2011, the sunset of section 1603 will place increased emphasis on optimizing the use of tax equity and the various structures that are available.
This audio conference presentation focuses on qualifying for 1603 for the balance of 2011, and also reviews the available structures used to monetize tax incentives – including partnership flips, sale-leaseback transactions, leases with credit pass-through arrangements, and prepayment structures. Our speaker discusses the advantages and disadvantages of each, and provides attendees with insight and guidance to help them prepare for life after section 1603.
Friday, July 8, 2011
Global Clinical Trials & ISO 14155: 2011 Compliance - Are Your Quality Systems Up to Date
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, August 10th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155:2011 Clinical Investigations of Medical Devices for Human Subjects - Good Clinical Practices (2nd edition)?
ISO 14155 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials. First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards. With over 65 pages of detailed requirements, ISO 14155:2011 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your systems are compliant with every component of this global standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155:2011 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements. This topic is especially timely, since the ISO 14155 standard was just released in January, 2011 and many companies are undergoing internal quality system updates to ensure their SOPs are compliant. This presentation is designed to make sure each member of the clinical, regulatory and quality teams fully understand what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day-to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 including areas now harmonized with other standards, and get useful tips about how to navigate in-house quality system improvements designed to ensure compliance with the new ISO 14155: 2011 standard.
Are your quality systems for clinical trials compliant with ISO 14155:2011 Clinical Investigations of Medical Devices for Human Subjects - Good Clinical Practices (2nd edition)?
ISO 14155 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials. First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards. With over 65 pages of detailed requirements, ISO 14155:2011 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your systems are compliant with every component of this global standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155:2011 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements. This topic is especially timely, since the ISO 14155 standard was just released in January, 2011 and many companies are undergoing internal quality system updates to ensure their SOPs are compliant. This presentation is designed to make sure each member of the clinical, regulatory and quality teams fully understand what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day-to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 including areas now harmonized with other standards, and get useful tips about how to navigate in-house quality system improvements designed to ensure compliance with the new ISO 14155: 2011 standard.
Wednesday, July 6, 2011
Process Validation – Implementing the Finalized FDA Guidance
is being presented by Todd Arney, Principal Consultant, with Technical & Quality Services, LLC and airs on Thursday, August 4th, 2011. For more details, or to register please visit our site at www.fxconferences.com
This audio conference presentation discusses the relevant regulatory requirements and current standards for process validation, and provides attendees with insight and practical guidance on how to implement them. Our speaker draws on real-life examples and shares experience and insight on the real problems fellow industry professionals are wrestling with.
The presentation reviews the fundamental regulatory requirements for process validation, and builds upon them in successive layers with current industry standards. The takeaway for attendees is a comprehensive bottom-up plan of action that pharmaceutical professionals can follow to either establish their own validation programs or enhance the ones they already have in place.
This audio conference presentation discusses the relevant regulatory requirements and current standards for process validation, and provides attendees with insight and practical guidance on how to implement them. Our speaker draws on real-life examples and shares experience and insight on the real problems fellow industry professionals are wrestling with.
The presentation reviews the fundamental regulatory requirements for process validation, and builds upon them in successive layers with current industry standards. The takeaway for attendees is a comprehensive bottom-up plan of action that pharmaceutical professionals can follow to either establish their own validation programs or enhance the ones they already have in place.
Tuesday, July 5, 2011
Technical Documentation Requirements for Device Approval in the EU
is being presented by Tamas Borsai, Division Manager, MHS - Customer Service and Quality, with TUV SUD America Inc. and airs on Tuesday, August 9th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Subscribe to:
Posts (Atom)