is being presented by Xavier Marchand, COO, with JBI Studios and airs on Tuesday, April 6, 2010. For more details or to register, please visit our site at www.fxconferences.com
Narrators on green screen, real-life scenarios, interview simulations… Video content can transform the learner experience. Thanks to plummeting costs of production and distribution, video is becoming a common component of eLearning courses. However, in order to optimize the video budget, it is important to understand the different solutions and how they impact the production process, the production crew needed, the editing effort, and production timeframes.
This audio conference presentation stops short of delving into all of the technical details of video production, but helps decision makers and content developers understand the main quantitative and qualitative aspects of video production, and also discusses the wide range of possibilities available for using video content in multilingual deployments.
Wednesday, February 24, 2010
Friday, February 19, 2010
Good Auditing Practices for EU Notified Body Audits
is being presented by Theo Nusselder, Founder & Director, of cePartner4u and airs on Tuesday, March 30, 2010. For more details or to register, please visit our site at www.fxconferences.com
Are you ready for a Notified Body audit? The European Medical Devices Directive requires that manufacturers of medium- and high-risk devices apply for an assessment of the manufacturing process and the technical documentation. The manufacturer is responsible for the design, manufacture, packaging and labeling of a device before it is placed on the market, regardless of whether these operations are carried out by the manufacturer or outsourced to a third party. The quality system must ensure that the products conform to the requirements of the Directive at every stage, from design to final inspection.
The Notified Body must audit the quality system to determine whether it meets the requirements, and the auditors have thorough knowledge of the rules on the inspections. Such rules are given in ISO requirements for audit and certification of management systems (ISO 19011:2002) and GHTF guidelines for Regulatory Auditing of Medical Device Manufacturers (GHTF/SG4/N28R4:2008). In this audio conference presentation attendees learn how to use these rules as a guide to Good Auditing Practice for the Notified Body assessment and CE-certification procedures.
Are you ready for a Notified Body audit? The European Medical Devices Directive requires that manufacturers of medium- and high-risk devices apply for an assessment of the manufacturing process and the technical documentation. The manufacturer is responsible for the design, manufacture, packaging and labeling of a device before it is placed on the market, regardless of whether these operations are carried out by the manufacturer or outsourced to a third party. The quality system must ensure that the products conform to the requirements of the Directive at every stage, from design to final inspection.
The Notified Body must audit the quality system to determine whether it meets the requirements, and the auditors have thorough knowledge of the rules on the inspections. Such rules are given in ISO requirements for audit and certification of management systems (ISO 19011:2002) and GHTF guidelines for Regulatory Auditing of Medical Device Manufacturers (GHTF/SG4/N28R4:2008). In this audio conference presentation attendees learn how to use these rules as a guide to Good Auditing Practice for the Notified Body assessment and CE-certification procedures.
Wednesday, February 17, 2010
Comparative Costs of Clinical Development in CEE and Other Regions
is being presented by Dr. Malgorzata Szerszeniewska, CEO, of Easthorn Clinical Services in CEE and airs on Wednesday, March 24, 2010. For more details or to register, please visit our site at www.fxconferences.com
It has recently been shown that the cost of clinical trials may play a crucial role in the drug development process. A lot of the most innovative biotech companies struggled financially last year and many programs have been put on hold or cancelled due to cash flow problems. A lot of companies have had difficulties in finding partners to help them financially to complete even very promising programs. That is why the cost of conducting clinical trials has become one of the major factors for pharma companies’ drug development strategies, their pipelines, and their CRO selection criteria. As market volume shrank CROs had to compete for fewer studies and price has become an important selection criterion.
This presentation provides a comparison of clinical trial costs in central and eastern europe and other representative regions. Our speaker addresses a variety of factors influencing the costs and discusses the dynamics and directions of recent changes. This information is of use in future budget planning, strategic country selection for specific clinical trials and minimizing financial surprises while running trials in CEE.
It has recently been shown that the cost of clinical trials may play a crucial role in the drug development process. A lot of the most innovative biotech companies struggled financially last year and many programs have been put on hold or cancelled due to cash flow problems. A lot of companies have had difficulties in finding partners to help them financially to complete even very promising programs. That is why the cost of conducting clinical trials has become one of the major factors for pharma companies’ drug development strategies, their pipelines, and their CRO selection criteria. As market volume shrank CROs had to compete for fewer studies and price has become an important selection criterion.
This presentation provides a comparison of clinical trial costs in central and eastern europe and other representative regions. Our speaker addresses a variety of factors influencing the costs and discusses the dynamics and directions of recent changes. This information is of use in future budget planning, strategic country selection for specific clinical trials and minimizing financial surprises while running trials in CEE.
Friday, February 12, 2010
Is Your Product Development Cycle Ready for IEC 60601-1 3rd Edition?
is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Thursday, March 4, 2010. For more details or to register, please visit our site at www.fxconferences.com
Development and adoption of the IEC 60601-1 standard has been a long and complicated process. Four years after the standard was published, there remains much confusion. This audio conference takes a look at the ever-changing international and regulatory requirements impacted by the 3rd edition of IEC 60601-1. What is the best strategy for your company when it comes to designing your product to IEC 60601-1? Should you design and test to 2nd or 3rd edition, or both? That depends on when and where you plan to market your medical electrical product, whether you will be selling legacy products, and if there are significant changes expected in the future that may require retesting or resubmission to a national regulatory authority.
In this audio conference, 60601 expert Leo Eisner discusses the current status of IEC 60601-1 3rd edition, scheduled changes and important regulatory dates, and how the collateral and particular standards are aligned to 3rd edition. The presentation also covers points to consider when setting up a company transition strategy.
The third edition of this cornerstone standard for medical electrical devices has gone through major changes since 2nd edition. Ease your 60601-1 regulatory compliance strategy stress with detailed guidance from a leading expert.
Development and adoption of the IEC 60601-1 standard has been a long and complicated process. Four years after the standard was published, there remains much confusion. This audio conference takes a look at the ever-changing international and regulatory requirements impacted by the 3rd edition of IEC 60601-1. What is the best strategy for your company when it comes to designing your product to IEC 60601-1? Should you design and test to 2nd or 3rd edition, or both? That depends on when and where you plan to market your medical electrical product, whether you will be selling legacy products, and if there are significant changes expected in the future that may require retesting or resubmission to a national regulatory authority.
In this audio conference, 60601 expert Leo Eisner discusses the current status of IEC 60601-1 3rd edition, scheduled changes and important regulatory dates, and how the collateral and particular standards are aligned to 3rd edition. The presentation also covers points to consider when setting up a company transition strategy.
The third edition of this cornerstone standard for medical electrical devices has gone through major changes since 2nd edition. Ease your 60601-1 regulatory compliance strategy stress with detailed guidance from a leading expert.
Thursday, February 11, 2010
QA Oversight of Vendor Management
is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Wednesday, March 17, 2010. For more details or to register, please visit our site at www.fxconferences.com
Managing vendors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.
This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.
Managing vendors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.
This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.
Subscribe to:
Posts (Atom)