is being presented by Dan O’Leary, President, of Ombu Enterprises,
LLC, and airs on Thursday, June 7th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Process capability analysis examines the inherent variability in a process,
including the statistical distribution of the process output. When the
measurement uses variables, data process variability is the “spread” of a
process in statistical control. When the measurement involves attributes,
process capability is often the proportion of nonconforming units. Often,
process capability uses an index that relates process variability and process
specifications.
This audio conference explains the underlying statistics of the most
commonly used capability indices. In particular, the presentation shows how to
use data from x-bar and R charts to calculate these process capability indices.
With an understanding of process capability indices, the speaker then examines
applications for medical devices. This immediately brings in the FDA QSR
requirement to identify valid statistical techniques to control process
capability and product characteristics. The audio conference illustrates
applications of process capability indices in both FDA QSR and ISO 13485 systems
using both examples and FDA Warning Letters to illustrate the issues.
Wednesday, May 30, 2012
Tuesday, May 15, 2012
Crisis Management for the FDA-Regulated Company
is being presented by Michael A. Swit, Esq., Special Counsel, FDA Practice, with Duane Morris LLP and airs on Tuesday, May 22nd, 2012. For more details, or to register please visit our site at www.fxconferences.com
At any moment, lightning can strike your FDA-regulated company. It may take the form of an unexpected serious adverse event such as a death attributed to your product, forcing you to consider a recall -- or an FDA inspection exposing severe quality issues – or a tampering incident such as J&J faced twice with Tylenol®. Regardless of how the crisis arises, it is vital that your company be prepared in advance to address the crisis immediately and responsibly.
This audio conference looks at key issues and FDA-regulated company might face during a crisis related to products or operations regulated by FDA, and how to respond to them. Drawing on a real-life case study that directly involved the speaker – the generic drug scandal that rocked FDA and industry during the late 1980s – the presentation reviews how to be prepared for a crisis and how to respond when one arises.
One never expects to be struck by lightning, and if you are not prepared in advance, it likely will be too late to react in the best manner to protect not only the public health, but also to responsibly mitigate the impact on your company and all its stakeholders from employees to shareholders.
At any moment, lightning can strike your FDA-regulated company. It may take the form of an unexpected serious adverse event such as a death attributed to your product, forcing you to consider a recall -- or an FDA inspection exposing severe quality issues – or a tampering incident such as J&J faced twice with Tylenol®. Regardless of how the crisis arises, it is vital that your company be prepared in advance to address the crisis immediately and responsibly.
This audio conference looks at key issues and FDA-regulated company might face during a crisis related to products or operations regulated by FDA, and how to respond to them. Drawing on a real-life case study that directly involved the speaker – the generic drug scandal that rocked FDA and industry during the late 1980s – the presentation reviews how to be prepared for a crisis and how to respond when one arises.
One never expects to be struck by lightning, and if you are not prepared in advance, it likely will be too late to react in the best manner to protect not only the public health, but also to responsibly mitigate the impact on your company and all its stakeholders from employees to shareholders.
Tuesday, May 8, 2012
Dollars and Sense – The Cost of Quality (COQ) Model and the Bottom Line
is being presented by Rene D. Massengale, President, of Global Food
Quality Concepts, LLC and airs on Wednesday, May 16th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The food and beverage industry is faced with increasing pressure to improve the safety and quality of products for human consumption while still maintaining a profitable bottom line. Successful companies understand that quality management is vital to successfully meeting this challenge, but how does the cost of quality affect the bottom line?
Cost of Quality is defined as the cost associated with detecting and avoiding quality failures. It is the cost associated with monitoring, detecting, and correcting errors in manufacturing or personnel. A Cost of Quality model is a quality management tool that can be integrated into other quality management systems to better understand and track the cost of quality failure over time. It translates the language of quality into the language of dollars understood by senior management.
This audio conference presentation explores quality costs, the Cost of Quality (COQ) model, and how it can be used to measure the real benefit derived from quality management efforts. In addition, our speaker discusses how Cost of Quality can be used to track the impact of quality compliance and noncompliance on the organization’s revenues from a risk management perspective.
The food and beverage industry is faced with increasing pressure to improve the safety and quality of products for human consumption while still maintaining a profitable bottom line. Successful companies understand that quality management is vital to successfully meeting this challenge, but how does the cost of quality affect the bottom line?
Cost of Quality is defined as the cost associated with detecting and avoiding quality failures. It is the cost associated with monitoring, detecting, and correcting errors in manufacturing or personnel. A Cost of Quality model is a quality management tool that can be integrated into other quality management systems to better understand and track the cost of quality failure over time. It translates the language of quality into the language of dollars understood by senior management.
This audio conference presentation explores quality costs, the Cost of Quality (COQ) model, and how it can be used to measure the real benefit derived from quality management efforts. In addition, our speaker discusses how Cost of Quality can be used to track the impact of quality compliance and noncompliance on the organization’s revenues from a risk management perspective.
Thursday, May 3, 2012
Industry Update – Europe's New Pharmacovigilance Regulations
is being presented by Dr. Ulrich Granzer, President, Granzer
Regulatory Consulting & Services and airs on Tuesday, May 15th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The EU parliament and the EU Council have issued a new pharmacovigilance regulation, which will come into force in July. The legislation defines new and additional tasks and responsibilities for the Coordination Group, defines a new “urgent union procedure” for pharmacovigilance, and also provides a definition for post authorization safety and efficacy studies and how these new tasks are to be performed. For this particular set of tasks a new body is being established, called PRAC, which will perform safety evaluations. Opinions of the PRAC will then be adopted by the EMA or, in the case of older or national registrations, the Coordination Group for the Decentralized and the Mutual recognition procedure, the CMDh. This new system will be in charge of all critical pharmacovigilance items and issues.
In this audio conference presentation, our speaker discusses these new changes to the EU pharmacovigilance rules, as well as potential critical issues arising from the EU’s complexity and decision-making process.
The EU parliament and the EU Council have issued a new pharmacovigilance regulation, which will come into force in July. The legislation defines new and additional tasks and responsibilities for the Coordination Group, defines a new “urgent union procedure” for pharmacovigilance, and also provides a definition for post authorization safety and efficacy studies and how these new tasks are to be performed. For this particular set of tasks a new body is being established, called PRAC, which will perform safety evaluations. Opinions of the PRAC will then be adopted by the EMA or, in the case of older or national registrations, the Coordination Group for the Decentralized and the Mutual recognition procedure, the CMDh. This new system will be in charge of all critical pharmacovigilance items and issues.
In this audio conference presentation, our speaker discusses these new changes to the EU pharmacovigilance rules, as well as potential critical issues arising from the EU’s complexity and decision-making process.
Wednesday, May 2, 2012
HFE Usability Testing: Medical Device Industry Panel
is being presented by Maria Shepherd & Kathleen
Whanger, President & Senior Quality Engineer, with Data Decision Group & Boston Scientific and airs on Thursday, May 10th, 2012. For more details or to register, please visit our site at www.fxconferences.com
The Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design was released by the FDA in June, 2011. It states that, as part of design control, manufacturers must conduct a risk analysis to assess/mitigate risks associated with device use. In addition, the FDA expects the manufacturer will perform human factors engineering and usability testing as a part of the product development process.
FDA takes these human factors requirements seriously, requiring a systematic assessment that incorporates usability testing to determine how the device will be used, the environment in which it will be used, and existing use-related hazards. Under these circumstances, manufacturers should provide FDA with a report that summarizes the human factors processes, evaluations, and results of validation testing as part of their pre-market applications or submission.
The Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design was released by the FDA in June, 2011. It states that, as part of design control, manufacturers must conduct a risk analysis to assess/mitigate risks associated with device use. In addition, the FDA expects the manufacturer will perform human factors engineering and usability testing as a part of the product development process.
FDA takes these human factors requirements seriously, requiring a systematic assessment that incorporates usability testing to determine how the device will be used, the environment in which it will be used, and existing use-related hazards. Under these circumstances, manufacturers should provide FDA with a report that summarizes the human factors processes, evaluations, and results of validation testing as part of their pre-market applications or submission.
Tuesday, May 1, 2012
Meeting the Linguistic Requirements for EMA Submissions
is being presented by Anabel Pérez, Senior Project Manager, with ForeignExchange Translations and airs on Wednesday, May 9th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.
In this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.
Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.
In this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.
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