is being presented by Terri Mead, President, of Solutions2Projects, LLC and airs on Wednesday, May 25th, 2011. For more details or to register, please visit our site at www.fxconferences.com
In the past, vendor audits were standard practice prior to the purchase of, or as part of validating, an IT system. As resources have gotten tighter and life sciences companies perhaps perceived less of a threat from the FDA on computer validation, many companies have moved away from performing vendor audits.
These days, FDA is scrutinizing IT systems, and has not overlooked the tendency with many companies to try and justify their way out of conducting vendor audits. This is true for both the outsourcing of processes to CROs and the implementation of IT systems on-site. With FDA’s focus on computer systems as part of PAIs and other inspections, ignoring vendor audits is a risk you can’t afford to take.
This audio conference presentation takes attendees through the elements of a vendor audit for both the purchase of software for a validated system, and for outsourcing of services that include IT systems such as clinical trial management.
Monday, May 9, 2011
Friday, May 6, 2011
Regulatory Requirements for Medical Device Calibration Programs
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Thursday, June 30th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Quality Management Systems (QMS) typically include provisions for the control of inspection, measuring, and test equipment. The QSR requirements are in 21 CFR §820.72, while the ISO 13485 requirements are in Clause 7.6.
Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. These procedures must include simple calibration stickers to aid in understanding accuracy and precision.
This audio conference explains the concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. The audio conference describes the concepts of accuracy and precision that define the measuring equipment’s requirements, and explains the meaning of traceability. With these concepts, the presentation moves to an analysis of FDA requirements and ISO 13485 requirements.
Quality Management Systems (QMS) typically include provisions for the control of inspection, measuring, and test equipment. The QSR requirements are in 21 CFR §820.72, while the ISO 13485 requirements are in Clause 7.6.
Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. These procedures must include simple calibration stickers to aid in understanding accuracy and precision.
This audio conference explains the concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. The audio conference describes the concepts of accuracy and precision that define the measuring equipment’s requirements, and explains the meaning of traceability. With these concepts, the presentation moves to an analysis of FDA requirements and ISO 13485 requirements.
Thursday, May 5, 2011
The 2011 ISO 14155 Revision: Keeping SOPs Up-to-Date
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Thursday, June 16th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The ISO 14155 standard for the conduct of clinical trials -- published in 2003 and updated in 2009 -- was revised again in 2011. However, some companies still haven't updated their standard operating procedures (SOPs) to reflect the 2009 revision, and lack the internal processes to ensure that SOPs are always updated in concert with new or revised regulations and guidance.
This audio conference presentation outlines a process by which companies can keep up-to-date with changes in regulations and guidance, and make sure their SOPs and working practice documents (WPDs) are in compliance with the latest regulatory requirements and guidance.
Our speaker uses the latest ISO 14155 guidance update as an example, to show how a robust process for regulatory intelligence gathering and SOP review can keep you on top of the latest standards. The presentation reviews the important changes in this latest version of the ISO 14155 guidance, and draws upon recent real-life client experience to look at how these can be incorporated into revisions to SOPs and WPDs.
The ISO 14155 standard for the conduct of clinical trials -- published in 2003 and updated in 2009 -- was revised again in 2011. However, some companies still haven't updated their standard operating procedures (SOPs) to reflect the 2009 revision, and lack the internal processes to ensure that SOPs are always updated in concert with new or revised regulations and guidance.
This audio conference presentation outlines a process by which companies can keep up-to-date with changes in regulations and guidance, and make sure their SOPs and working practice documents (WPDs) are in compliance with the latest regulatory requirements and guidance.
Our speaker uses the latest ISO 14155 guidance update as an example, to show how a robust process for regulatory intelligence gathering and SOP review can keep you on top of the latest standards. The presentation reviews the important changes in this latest version of the ISO 14155 guidance, and draws upon recent real-life client experience to look at how these can be incorporated into revisions to SOPs and WPDs.
Wednesday, May 4, 2011
Record-keeping and Recall Requirements Under the New FSMA
is being presented by Mitchell S. Fuerst, Esq., Managing Partner, with Fuerst & Ittleman, P.L. and airs on Thursday, June 9th, 2011. For more details, or to register please visit our site at www.fxconferences.com
With the passage of the FDA Food Safety Modernization Act (FSMA), a lot of attention has been devoted to the new recall authority granted to the FDA. While the FDA now has the authority to issue mandatory recalls when it deems it is necessary to protect against serious adverse health consequences, this is not the only consequence of mandatory recall authority. With recall authority comes a variety of new record-keeping requirements that food growers and manufacturers must abide by under the FSMA.
Although the FSMA limits this recall authority to situations where the food producer has not voluntarily recalled its own goods, the record-keeping requirements are broader in scope and allow the FDA to request business records before a recall is ever contemplated. Where the FSMA gives authority to FDA to require food producers to turn over records before a recall has been ordered, these record-keeping requirements are a central feature of the mandatory recall scheme.
Knowledge of these record-keeping requirements is critical to understanding the entire recall scheme. This audio conference presents an in-depth look at the new record-keeping requirements in the FSMA. Beginning with an overview of the requirements and FDA recall authority in general, the speaker explores specific obligations imposed by the FSMA, and examines the record-keeping requirements within the overall recall scheme to provide an understanding of how the provisions all work together in practice.
With the passage of the FDA Food Safety Modernization Act (FSMA), a lot of attention has been devoted to the new recall authority granted to the FDA. While the FDA now has the authority to issue mandatory recalls when it deems it is necessary to protect against serious adverse health consequences, this is not the only consequence of mandatory recall authority. With recall authority comes a variety of new record-keeping requirements that food growers and manufacturers must abide by under the FSMA.
Although the FSMA limits this recall authority to situations where the food producer has not voluntarily recalled its own goods, the record-keeping requirements are broader in scope and allow the FDA to request business records before a recall is ever contemplated. Where the FSMA gives authority to FDA to require food producers to turn over records before a recall has been ordered, these record-keeping requirements are a central feature of the mandatory recall scheme.
Knowledge of these record-keeping requirements is critical to understanding the entire recall scheme. This audio conference presents an in-depth look at the new record-keeping requirements in the FSMA. Beginning with an overview of the requirements and FDA recall authority in general, the speaker explores specific obligations imposed by the FSMA, and examines the record-keeping requirements within the overall recall scheme to provide an understanding of how the provisions all work together in practice.
Monday, May 2, 2011
EU Medical Device Classification - Overview and Update
is being presented by Mika Reinikainen, Managing Director, with Abnovo Ltd. and airs on Tuesday, May 10th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Medical device companies wishing to market their products in the European Union must first determine the classification of their devices in accordance with rules set out in Annex IX of Council Directive 93/42/EEC. Device classification is based on the level of risk, from Class I (low risk) to Class III (high risk), and while manufacturers can self-certify certain low-risk devices, those posing a higher risk to users must have their classification verified by a Notified Body. This tiered system can lead to confusion, as device companies attempt to classify a wide variety of products.
This audio conference provides a detailed overview of the EU medical device classification system, and provides an update on the latest developments. The presentation reviews the various classes and categories, exploring the reasons and basic concepts behind them, and what they mean in terms of compliance. Using practical examples from industry, our speaker also discusses the emerging issue of classifying medical device software, as well as special devices and reclassification.
Medical device companies wishing to market their products in the European Union must first determine the classification of their devices in accordance with rules set out in Annex IX of Council Directive 93/42/EEC. Device classification is based on the level of risk, from Class I (low risk) to Class III (high risk), and while manufacturers can self-certify certain low-risk devices, those posing a higher risk to users must have their classification verified by a Notified Body. This tiered system can lead to confusion, as device companies attempt to classify a wide variety of products.
This audio conference provides a detailed overview of the EU medical device classification system, and provides an update on the latest developments. The presentation reviews the various classes and categories, exploring the reasons and basic concepts behind them, and what they mean in terms of compliance. Using practical examples from industry, our speaker also discusses the emerging issue of classifying medical device software, as well as special devices and reclassification.
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