ICH Guidelines
Month: June 2014
Statistical Considerations for ICH Guidelines
Statistical Considerations for ICH Guidelines
This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.
How well do you understand how you can utilize statistics to address the ICH guidelines? Most organizations have programs and procedures but fall short in the implementation of the tool and techniques used to apply the appropriate statistical tools.
This 2 day hands-on workshop explores the unique challenges facing all facets of a pharmaceutical and biotechnology company. Practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies. Participants will learn the major aspects of the statistical methods and discover how organizations and external authorities expect organizations to meet these guidelines.
Medical Device Reporting and handling of recalls
Medical Device Reporting and handling of recalls are closely tied to each other. While medical device reporting is the first part, recalls are the next in a series of actions a medical device manufacturer could take in some circumstances.
Medical Device Reporting
Medical Device Reporting and handling of recalls are very important to the medical device industry. MDR is the FDA’s mechanism for receiving significant medical device adverse events from manufacturers, importers and user facilities. The point of having such a mechanism in place is that adverse events can be detected and corrected quickly. Medical device manufacturers need to be familiar with the finer aspects of the MDR. Apart from medical device manufacturers; user facilities such as hospitals and nursing homes are required to report suspected medical device related deaths to both the FDA and the manufacturers.
Recall
Recalls constitute another crucial component of the complaint handling system. Medical device reporting and handling of recalls complement each other, as can be seen from an understanding of this exercise.
A recall is a process by which a medical device is removed from the market or corrected whenever the FDA finds that there is a reasonable possibility that the device could cause any of these: serious, adverse health consequences or death. The link between medical device reporting and handling of recalls assumes greater significance when one considers what a recall means. In simple terms, it is an action taken to address a problem existent in a medical device that violates FDA regulation.
Recalls can happen in any of these three situations: a) when a medical device comes with a defect, b) the possibility that it could pose a risk to health is probably high, or c) there exists a combination of these two. Different rules for recall exist for different classes of medical devices. It is imperative for manufacturers to be familiar with these.
Thus, medical device reporting and handling of recalls constitute a core element of safety.
The impact of effective complaint handling on quality system
Effective complaint handling makes an extremely important impact on the quality system. An effective complaint handling is at the core of a quality system. If a product enters the market having got FDA approval and still receives complaints, it means that the device needs to be worked on and the complaint redressed. Effective complaint handling on quality system is meaningful when complaints are thoroughly analyzed and investigated.
Helps in correcting flaws
Complaints serve as a great means for making manufacturers of medical devices understand the problem at its root. It is this understanding that will help them to come up with solutions to these problems. Having an effective complaint handling on quality system in place is an FDA requirement from a medical device manufacturer. Complaints are the platform from which to evaluate, investigate and analyze the device and later take corrective action.
The MDR
To facilitate effective complaint handling on quality system; the FDA has a mechanism. Called the Medical Device Reporting (MDR); this system is meant for receiving medical device adverse events from manufacturers, importers and user facilities. This mechanism helps in quick detection and correction of adverse events. User Facilities (e.g., hospitals, nursing homes) need to report suspected medical device related deaths to both the FDA and the manufacturers.
Software Risk Management Process in medical devices
Software Risk Management Process in medical devices is an integral part of quality. This fact is recognized by both the FDA and ISO 14971:2007, both of which are formulated on the acknowledgement that there is an element of risk inherent in the use of medical device technology.
It is all about risk reduction
Software Risk Management Process in medical devices is built on the premise that the user’s safety is paramount when using a medical device. That is why Software Risk Management Process in medical devices has the essential goal of reducing product risk. Its other primary goal lies in identifying and understanding the level of risk that remains after this is done, and to assess the impact that this has at this stage on both the user’s safety and the effectiveness of the product.
The role of ISO 14971:2007
So, any medical device company has to implement a robust framework within which it can apply the risk management practices of ISO 14971:2007. The main aim of ISO 14971:2007, a globally accepted standard for medical device safety, is to help medical device companies better the safety and effectiveness of their products while being compliant with regulatory requirements.
Other important requirement
While software Risk Management Process in medical devices has to show compliance with the requirements set out in ISO 14971:2007; Hazard and Risk Analysis documentation is another core requirement of this regulation.
With Hazard and Risk Analysis documentation, device companies should show that they have implemented risk management and risk control processes that can demonstrably and reproducibly be located all the way from the product design right up to its verification and validation records.
References:
http://www.mks.com/solutions/by-industry/medical-devices/iso-14971
The all-important nature of validation of pharmaceutical water systems
The significance of validation of pharmaceutical water systems can be gauged from the fact that among the number of substances, raw materials and starting materials used in the production, processing and formulation of pharmaceutical products; water takes a position of primacy. This is because the hydrogen bonds that water has, along with its polarity, lend it a set of special chemical properties. Because water has these attributes; many different compounds are able to blend with it in the form of dissolving, absorbing, adsorbing or suspension.
Yet, there is an irony, because this very unique quality of water –of its being able to blend easily –which makes it so important, also makes it a magnet and breeding ground for many contaminants. Water can meld different compounds, as well as contaminants. This is why effective and proper validation of pharmaceutical water systems is necessary and important.
Approaches to validation of pharmaceutical water systems
Validation of pharmaceutical water systems can be approached in three ways: prospective, concurrent and retrospective.
As the names suggest, prospective validation of pharmaceutical water systems is the validation that is carried out when an altogether new product is about to be introduced, or when there is a change in the process, which is likely to impact the attributes of water in the pharmaceutical product.
Concurrent validation of pharmaceutical water systems is the one that is carried out during the manufacturing process.
Retrospective validation of pharmaceutical water systems is one that is carried out after the product is out it the market. This is usually carried out when the company receives complaints about the product quality.
References:
http://www.authorstream.com/Presentation/aSGuest114007-1189653-water-validation/
http://www.bioline.org.br/request?pr10011
Software Risk Management Process in medical devices
Software Risk Management Process in medical devices is an integral part of quality. This fact is recognized by both the FDA and ISO 14971:2007, both of which are formulated on the acknowledgement that there is an element of risk inherent in the use of medical device technology.
It is all about risk reduction
Software Risk Management Process in medical devices is built on the premise that the user’s safety is paramount when using a medical device. That is why Software Risk Management Process in medical devices has the essential goal of reducing product risk. Its other primary goal lies in identifying and understanding the level of risk that remains after this is done, and to assess the impact that this has at this stage on both the user’s safety and the effectiveness of the product.
The role of ISO 14971:2007
So, any medical device company has to implement a robust framework within which it can apply the risk management practices of ISO 14971:2007. The main aim of ISO 14971:2007, a globally accepted standard for medical device safety, is to help medical device companies better the safety and effectiveness of their products while being compliant with regulatory requirements.
Other important requirement
While software Risk Management Process in medical devices has to show compliance with the requirements set out in ISO 14971:2007; Hazard and Risk Analysis documentation is another core requirement of this regulation.
With Hazard and Risk Analysis documentation, device companies should show that they have implemented risk management and risk control processes that can demonstrably and reproducibly be located all the way from the product design right up to its verification and validation records.
References:
http://www.mks.com/solutions/by-industry/medical-devices/iso-14971
Software Risk Management Process in medical devices
Quality Assurance for Computer Systems Validation (CSV) is a critical aspect of the Life Sciences industry. Alternatively referred to as Software Validation, Quality Assurance for Computer Systems Validation broadly entails a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11.
Knowledge gap
Many companies have a difficulty in determining what needs to be done, to meet domestic and/or international regulations or business continuity requirements, as a result of which Quality Assurance for Computer Systems Validation becomes incomplete. On top of these, as if these issues were not enough, the FDA has escalated 21 CFR 11 inspections that include CSV, making the already difficult task of requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11 all the more complex. Something like a fifth of all incorrect Medical Device Recalls is attributed to unfulfilled Computer Systems Validation, meaning that Quality Assurance is a big casualty.
Bleak future
What does a prognosis of this scenario look like? If anything, the number of recalls and Official Actions by Regulatory Authorities (e.g. 483s, Warning Letters, etc.) due to the product’s inability to meet Quality Assurance for Computer Systems Validation is set to go up. The reason behind this outlook is that technology is advancing, which brings with it many attendant pitfalls. And, as companies consider Cloud Technologies; there are sure to be patient privacy issues such as HIPAA involved in all this.
Roll up your sleeves; get your CSV right!
The costs associated with lack of implementation of Quality Assurance for Computer Systems Validation is quite shocking. In 2013, a single incorrect implementation of Quality Assurance for Computer Systems Validation resulted in fines of up to $three billion. It is but natural that software projects that need CSV get overrun by long periods of time. Corrections required to be implemented into a system that has been issued a 483 due to Quality Assurance for Computer Systems Validation can cost a quarter of a million dollars. Imagine the sheer amount of money needed when multiple issues are found.
Yet another critical reason, for which Quality Assurance for Computer Systems Validation has to be met, come what may, is that CSV is a foundation to other discovery, development & commercialization of products. So, not meeting Quality Assurance for Computer Systems Validation can result in a spiral: all the concomitant and ensuing efforts go waste.
All of this means that the need to meet Quality Assurance for Computer Systems Validation could not be more urgent or important.
The extreme importance of Quality Assurance for Computer Systems Validation (CSV)
Quality Assurance for Computer Systems Validation (CSV) is a critical aspect of the Life Sciences industry. Alternatively referred to as Software Validation, Quality Assurance for Computer Systems Validation broadly entails a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11.
Knowledge gap
Many companies have a difficulty in determining what needs to be done, to meet domestic and/or international regulations or business continuity requirements, as a result of which Quality Assurance for Computer Systems Validation becomes incomplete. On top of these, as if these issues were not enough, the FDA has escalated 21 CFR 11 inspections that include CSV, making the already difficult task of requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11 all the more complex. Something like a fifth of all incorrect Medical Device Recalls is attributed to unfulfilled Computer Systems Validation, meaning that Quality Assurance is a big casualty.
Bleak future
What does a prognosis of this scenario look like? If anything, the number of recalls and Official Actions by Regulatory Authorities (e.g. 483s, Warning Letters, etc.) due to the product’s inability to meet Quality Assurance for Computer Systems Validation is set to go up. The reason behind this outlook is that technology is advancing, which brings with it many attendant pitfalls. And, as companies consider Cloud Technologies; there are sure to be patient privacy issues such as HIPAA involved in all this.
Roll up your sleeves; get your CSV right!
The costs associated with lack of implementation of Quality Assurance for Computer Systems Validation is quite shocking. In 2013, a single incorrect implementation of Quality Assurance for Computer Systems Validation resulted in fines of up to $three billion. It is but natural that software projects that need CSV get overrun by long periods of time. Corrections required to be implemented into a system that has been issued a 483 due to Quality Assurance for Computer Systems Validation can cost a quarter of a million dollars. Imagine the sheer amount of money needed when multiple issues are found.
Yet another critical reason, for which Quality Assurance for Computer Systems Validation has to be met, come what may, is that CSV is a foundation to other discovery, development & commercialization of products. So, not meeting Quality Assurance for Computer Systems Validation can result in a spiral: all the concomitant and ensuing efforts go waste.
All of this means that the need to meet Quality Assurance for Computer Systems Validation could not be more urgent or important.
Medical Device Reporting and handling of recalls
Medical Device Reporting and handling of recalls are closely tied to each other. While medical device reporting is the first part, recalls are the next in a series of actions a medical device manufacturer could take in some circumstances.
Medical Device Reporting
Medical Device Reporting and handling of recalls are very important to the medical device industry. MDR is the FDA’s mechanism for receiving significant medical device adverse events from manufacturers, importers and user facilities. The point of having such a mechanism in place is that adverse events can be detected and corrected quickly. Medical device manufacturers need to be familiar with the finer aspects of the MDR. Apart from medical device manufacturers; user facilities such as hospitals and nursing homes are required to report suspected medical device related deaths to both the FDA and the manufacturers.
Recall
Recalls constitute another crucial component of the complaint handling system. Medical device reporting and handling of recalls complement each other, as can be seen from an understanding of this exercise.
A recall is a process by which a medical device is removed from the market or corrected whenever the FDA finds that there is a reasonable possibility that the device could cause any of these: serious, adverse health consequences or death. The link between medical device reporting and handling of recalls assumes greater significance when one considers what a recall means. In simple terms, it is an action taken to address a problem existent in a medical device that violates FDA regulation.
Recalls can happen in any of these three situations: a) when a medical device comes with a defect, b) the possibility that it could pose a risk to health is probably high, or c) there exists a combination of these two. Different rules for recall exist for different classes of medical devices. It is imperative for manufacturers to be familiar with these.
Thus, medical device reporting and handling of recalls constitute a core element of safety.
globalcompliancepaneltraining 