is being presented by Dan O’Leary, President, of Ombu Enterprises, LLC and airs on Thursday, April 19th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Quality audits typically involve sampling of records and other documents. When the auditor does this a lot of questions come up, such as how many records to sample and how many nonconforming records are too many. In fact, there is a more fundamental question about nonconforming records. If a record has, say, three errors does the auditor count it three times – once for each error – or just once, as a nonconforming record? Some auditors determine the sample size without using statistical techniques. Is this ever acceptable? Sampling records in an audit is not the same as sampling at incoming inspection; the underlying assumptions are different, so the methods need to change.
This audio conference examines the issues in audit sampling and provides the answers you need to plan your audit. Participants learn the difference between counting nonconformities and counting nonconformances and which techniques to apply in a quality audit. An audit may need to determine the error rate in a process, or least show that it is not too great. Attendees learn some standard sampling plans as well the reason they work. As an example, participants will analyze the sampling plans the FDA uses as part of the Quality System Technique (QSIT)
Showing posts with label Ombu Enterprises. Show all posts
Showing posts with label Ombu Enterprises. Show all posts
Wednesday, April 11, 2012
Thursday, June 2, 2011
Management Responsibilities Under FDA's Quality System Regulation
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Thursday, July 28th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
The FDA’s Quality System Regulation (QSR), for medical devices marketed in the US, includes requirements for management responsibility. There are five major components: Quality Policy, Organization, Management Review, Quality Planning, and Quality System Procedures. This presentation explains the various components and offers recommendations for implementation.
It also examines the structure of regulation in 21 CFR §820.20 and its constituent parts. This section has many defined terms that bear on the understanding, and this presentation looks at these terms and explains what they mean.
Our speaker draws on many sources to provide attendees with understanding, including the regulation preamble – where FDA published its reasoning, intent and expectations – and also FDA’s Quality System Inspection Technique, which guides inspectors.
The presentation also examines some FDA warning letters to help participants understand the issues that FDA uncovers and considers important.
The FDA’s Quality System Regulation (QSR), for medical devices marketed in the US, includes requirements for management responsibility. There are five major components: Quality Policy, Organization, Management Review, Quality Planning, and Quality System Procedures. This presentation explains the various components and offers recommendations for implementation.
It also examines the structure of regulation in 21 CFR §820.20 and its constituent parts. This section has many defined terms that bear on the understanding, and this presentation looks at these terms and explains what they mean.
Our speaker draws on many sources to provide attendees with understanding, including the regulation preamble – where FDA published its reasoning, intent and expectations – and also FDA’s Quality System Inspection Technique, which guides inspectors.
The presentation also examines some FDA warning letters to help participants understand the issues that FDA uncovers and considers important.
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, April 28, 2011
Device Master Records & Device History Records: Are You Compliant?
is being presented by Dan O'Leary, President, with Ombu Enterprises and airs on Thursday, May 26th, 2011. For more details, or to register for this event please visit our site at www.fxconferences.com
The Device Master Record (DMR) and the Device History Record (DHR) serve to document your manufacturing process and the results, and also to assist in solving problems. Equally important, your DMR and DRH must align, and during an FDA inspection the investigator will check to make sure they do! Now is the time to understand, before you have to explain in a 483 response.
The DMR and DHR are part of four related documents that are important to your QMS. During design, you will create a Design History File (DHF) documenting how you developed the design and moved it to production. One of the major design outputs is the Device Master Record (DMR). However, you can put some of the information into the Quality System Record (QSR), which you must also create.
This audio conference presentation discusses the difference between the DMR and the QSR, and how to organize your information. While focusing on the DMR and DHR, the speaker also provides a roadmap for understanding the interlocking relationship among all four critical records. With this knowledge, you can ensure your QMS is efficient, effective, and compliant.
The Device Master Record (DMR) and the Device History Record (DHR) serve to document your manufacturing process and the results, and also to assist in solving problems. Equally important, your DMR and DRH must align, and during an FDA inspection the investigator will check to make sure they do! Now is the time to understand, before you have to explain in a 483 response.
The DMR and DHR are part of four related documents that are important to your QMS. During design, you will create a Design History File (DHF) documenting how you developed the design and moved it to production. One of the major design outputs is the Device Master Record (DMR). However, you can put some of the information into the Quality System Record (QSR), which you must also create.
This audio conference presentation discusses the difference between the DMR and the QSR, and how to organize your information. While focusing on the DMR and DHR, the speaker also provides a roadmap for understanding the interlocking relationship among all four critical records. With this knowledge, you can ensure your QMS is efficient, effective, and compliant.
Wednesday, February 9, 2011
Correction and CAPA: What's the Difference?
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Thursday, March 10th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Do you know the difference between corrective action and preventive action? The difference between them is confusing because many practitioners don’t realize these terms have specific meaning in the quality profession. These two terms probably create more misunderstanding for quality professionals than any other pair of words.
There are two reasons for this problem. First, people tend to apply colloquial language without realizing they are defined technical terms. Second, corrective action prevents the recurrence of a problem, so the language leads us, incorrectly, to call it preventive action. With the term “correction”, the confusion can become a morass.
These two terms have clear meaning in a Quality Management System, and the formal definitions highlight the difference. This presentation uses the definitions found in ISO 9000:2005 to help attendees understand the terms, and illustrates the differences with examples that clarify each term.
Do you know the difference between corrective action and preventive action? The difference between them is confusing because many practitioners don’t realize these terms have specific meaning in the quality profession. These two terms probably create more misunderstanding for quality professionals than any other pair of words.
There are two reasons for this problem. First, people tend to apply colloquial language without realizing they are defined technical terms. Second, corrective action prevents the recurrence of a problem, so the language leads us, incorrectly, to call it preventive action. With the term “correction”, the confusion can become a morass.
These two terms have clear meaning in a Quality Management System, and the formal definitions highlight the difference. This presentation uses the definitions found in ISO 9000:2005 to help attendees understand the terms, and illustrates the differences with examples that clarify each term.
Wednesday, January 19, 2011
Managing the Medical Device Supply Chain
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Wednesday, February 16th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Supply chains for medical devices are growing in importance as device manufacturers outsource products and services. As some of this outsourcing moves offshore and to low-cost countries, the supply chain becomes longer, more diverse, and more difficult to control. The medical device manufacturer, however, has the ultimate responsibility for the product, so supply chain management becomes a critical function.
FDA regulations for medical devices define the requirements for supplier selection, management, and control. ISO 13485 includes similar requirements. However, in February 2009, the Global Harmonization Task Force (GHTF) released a guidance document on controlling products and services from suppliers, and this guidance document has become the global de facto standard for supplier management.
This audio conference presentation helps attendees understand the regulations and the expectations of the GHTF guidance document, and how to go about implementing its provisions.
Supply chains for medical devices are growing in importance as device manufacturers outsource products and services. As some of this outsourcing moves offshore and to low-cost countries, the supply chain becomes longer, more diverse, and more difficult to control. The medical device manufacturer, however, has the ultimate responsibility for the product, so supply chain management becomes a critical function.
FDA regulations for medical devices define the requirements for supplier selection, management, and control. ISO 13485 includes similar requirements. However, in February 2009, the Global Harmonization Task Force (GHTF) released a guidance document on controlling products and services from suppliers, and this guidance document has become the global de facto standard for supplier management.
This audio conference presentation helps attendees understand the regulations and the expectations of the GHTF guidance document, and how to go about implementing its provisions.
Thursday, January 6, 2011
Risk Management for Medical Devices
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Wednesday, January 26th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Risk Management is vital in medical device design, manufacturing, and post-market surveillance. The FDA QSR requires risk analysis in the design phase, but realizes the need for life cycle management through the complaint system. The FDA recognizes ISO 14971:2007 as a consensus standard. In the European Union, EN ISO 14971:2007 is a harmonized standard and notified bodies will expect full compliance. ISO 13485:2003 also calls out the standard as preferred method.
This audio conference introduces the concepts of Risk Management in ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report. It covers the differences among Hazard, Harm, and Risk and explains how to evaluate each of them. The program describes development of a Risk Evaluation Matrix taking into account the probability of occurrence and the severity of the harm. The standard requires a list of known and foreseeable hazards as well as foreseeable sequences of events that could result in harm. The presentation describes the tools (FMEA, FTA, and HAACP) and their application.
Risk Management is vital in medical device design, manufacturing, and post-market surveillance. The FDA QSR requires risk analysis in the design phase, but realizes the need for life cycle management through the complaint system. The FDA recognizes ISO 14971:2007 as a consensus standard. In the European Union, EN ISO 14971:2007 is a harmonized standard and notified bodies will expect full compliance. ISO 13485:2003 also calls out the standard as preferred method.
This audio conference introduces the concepts of Risk Management in ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report. It covers the differences among Hazard, Harm, and Risk and explains how to evaluate each of them. The program describes development of a Risk Evaluation Matrix taking into account the probability of occurrence and the severity of the harm. The standard requires a list of known and foreseeable hazards as well as foreseeable sequences of events that could result in harm. The presentation describes the tools (FMEA, FTA, and HAACP) and their application.
Tuesday, November 2, 2010
Using Standards for Attribute Sampling
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Wednesday, December 1st, 2010. For more details or to register, please visit our site at www.fxconferences.com
This audio conference presentation helps attendees understand and implement acceptance sampling, explaining the basis for sampling plans, the binomial distribution, and showing how it helps us understand sampling plan performance using the operating characteristic (OC) curve. Participants gain a solid understanding of the risks involved in sampling by understanding the OC. Our speaker shows how the shape of curve describes risk, and identifies some of the most important points on the curve (AQL and RQL points).
The audio conference provides complete descriptions of three other important curves that help you understand a sampling plan: the average sample number (ASN), average outgoing quality (AOQ), and average total inspected (ATI).
The presentation provides a complete description of Z1.4, showing the process from receiving the lot to selecting the sample size to making the accept/reject decision. The speaker also examines c=0 plans using the curves described above. The OC curve, in these plans, has a different shape that can lead to problems. The presentation looks at some issues with converting from Z1.4 to c=0 plans, especially related to inventory levels and supplier evaluation.
This audio conference presentation helps attendees understand and implement acceptance sampling, explaining the basis for sampling plans, the binomial distribution, and showing how it helps us understand sampling plan performance using the operating characteristic (OC) curve. Participants gain a solid understanding of the risks involved in sampling by understanding the OC. Our speaker shows how the shape of curve describes risk, and identifies some of the most important points on the curve (AQL and RQL points).
The audio conference provides complete descriptions of three other important curves that help you understand a sampling plan: the average sample number (ASN), average outgoing quality (AOQ), and average total inspected (ATI).
The presentation provides a complete description of Z1.4, showing the process from receiving the lot to selecting the sample size to making the accept/reject decision. The speaker also examines c=0 plans using the curves described above. The OC curve, in these plans, has a different shape that can lead to problems. The presentation looks at some issues with converting from Z1.4 to c=0 plans, especially related to inventory levels and supplier evaluation.
Tuesday, October 5, 2010
Understanding QSR Acceptance Activities for Medical Devices
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Wednesday, November 10th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The FDA’s Quality System Regulation (QSR) sets requirements for acceptance activities related to medical device manufacture. The requirements cover three acceptance areas: receiving, in process, and final. In addition, QSR has specific requirements for procedures and minimum requirements for record keeping. This is one of the top five sections cited in FDA Warning Letters.
This audio conference explains the regulations and provides guidance on implementation. We analyze the regulations and discuss the FDA’s intent as provided in the preamble to the regulations. We also explain the guidance offered in FDA’s QSR Manual. This guidance helps manufacturers implement the regulations by clarifying the expectations and providing sample procedures and forms. This document is valuable, and even appears in an FDA Warning Letter as a recommendation to help a manufacturer come into full compliance.
The presentation includes an examination of some Warning Letters, reviews some mistakes that manufacturers have made, and looks at ways to avoid them. We also see a few instances where a Warning Letter does not align with the guidance in the QSR Manual or the QSR preamble.
The FDA’s Quality System Regulation (QSR) sets requirements for acceptance activities related to medical device manufacture. The requirements cover three acceptance areas: receiving, in process, and final. In addition, QSR has specific requirements for procedures and minimum requirements for record keeping. This is one of the top five sections cited in FDA Warning Letters.
This audio conference explains the regulations and provides guidance on implementation. We analyze the regulations and discuss the FDA’s intent as provided in the preamble to the regulations. We also explain the guidance offered in FDA’s QSR Manual. This guidance helps manufacturers implement the regulations by clarifying the expectations and providing sample procedures and forms. This document is valuable, and even appears in an FDA Warning Letter as a recommendation to help a manufacturer come into full compliance.
The presentation includes an examination of some Warning Letters, reviews some mistakes that manufacturers have made, and looks at ways to avoid them. We also see a few instances where a Warning Letter does not align with the guidance in the QSR Manual or the QSR preamble.
Wednesday, September 8, 2010
Statistical Concepts of Medical Device Process Validation
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Tuesday, October 5th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Process validation is an important element in medical device manufacturing, and this audio conference looks at the underlying statistical concepts to perform an effective process validation, examining elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.
When you cannot (or do not) fully verify process results by subsequent inspection and test this leads to sampling plans, and in this presentation our speaker discusses the use of attribute sampling plans in this context. When you validate the process with a high degree of assurance, this means your process achieves a certain process capability. The presentation looks at the concepts of process capability, especially the use of common processes capability indices, Cp and Cpk.
Process validation often employs three phases, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). One role of OQ explores the parameter space that defines the process and selects challenge points as part of the qualification protocol. This naturally leads to Designed Experiments as the exploratory tool. Designed experiments determine the limits of the parameter space for the process. The same techniques, especially full and fractional factorial experiments, can establish “worst case” conditions that become challenge points for the OQ phase of process validation.
Lastly, Risk Management (ISO 14971) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.
Process validation is an important element in medical device manufacturing, and this audio conference looks at the underlying statistical concepts to perform an effective process validation, examining elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.
When you cannot (or do not) fully verify process results by subsequent inspection and test this leads to sampling plans, and in this presentation our speaker discusses the use of attribute sampling plans in this context. When you validate the process with a high degree of assurance, this means your process achieves a certain process capability. The presentation looks at the concepts of process capability, especially the use of common processes capability indices, Cp and Cpk.
Process validation often employs three phases, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). One role of OQ explores the parameter space that defines the process and selects challenge points as part of the qualification protocol. This naturally leads to Designed Experiments as the exploratory tool. Designed experiments determine the limits of the parameter space for the process. The same techniques, especially full and fractional factorial experiments, can establish “worst case” conditions that become challenge points for the OQ phase of process validation.
Lastly, Risk Management (ISO 14971) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.
Tuesday, May 4, 2010
A Unified Approach to Complaints, Servicing, and FDA Reporting
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Tuesday, June 8th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
The FDA continues to focus on post-market surveillance, and one of the leading causes of Warning Letters is failure to implement an effective system to manage complaints. In addition, complaints can lead to MDRs, corrections, and removals. Warning Letters often cite implementation failures, or even no implementation, of these other systems. One reason that firms do a poor job is that these essential systems are not in Part 820, the Quality System Regulation, and are often misunderstood or ignored.
This presentation provides practical advice on the FDA requirements for complaints, but expands the traditional scope to include closely linked, but often overlooked processes. We explore the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. For Servicing, our speaker explains the requirements to analyze service reports, shows how service reports can trigger MDRs, and automatically become complaints. The presentation reduces the regulatory language to simple English and explains how you can implement an effective and unified system.
The FDA regulations require three sets of documents: written procedures, records of activities, and reports to the FDA. This presentation explains the requirements in the multiple systems (complaint management, corrective actions, service management, risk management, and field upgrades) the manufacturer must implement.
The FDA continues to focus on post-market surveillance, and one of the leading causes of Warning Letters is failure to implement an effective system to manage complaints. In addition, complaints can lead to MDRs, corrections, and removals. Warning Letters often cite implementation failures, or even no implementation, of these other systems. One reason that firms do a poor job is that these essential systems are not in Part 820, the Quality System Regulation, and are often misunderstood or ignored.
This presentation provides practical advice on the FDA requirements for complaints, but expands the traditional scope to include closely linked, but often overlooked processes. We explore the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. For Servicing, our speaker explains the requirements to analyze service reports, shows how service reports can trigger MDRs, and automatically become complaints. The presentation reduces the regulatory language to simple English and explains how you can implement an effective and unified system.
The FDA regulations require three sets of documents: written procedures, records of activities, and reports to the FDA. This presentation explains the requirements in the multiple systems (complaint management, corrective actions, service management, risk management, and field upgrades) the manufacturer must implement.
Monday, April 26, 2010
Process Validation for Medical Devices
is being presented by Dan O'Leary, President, Ombu Enterprises and airs on Wednesday, May 19th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Process validation is an integral part of any manufacturing system, but is especially important for medical devices, where regulations (FDA QSR and ISO 13485) lay out the requirements manufacturers must follow. It applies when a company cannot, or does not, perform 100% verification of the process output – the product. Since you cannot verify all of the product produced by the process, you need another way to ensure the process produces good output – process validation. Regulators often expect process validation when a manufacturer uses sampling plans for verification.
This presentation helps attendees understand how to perform process validation. Our speaker defines the concepts, and divides process validation into three phases: Installation Qualification (IQ), Operational Qualification (OQ), and Production Qualification (PQ). The presentation explains how to develop protocols for each phase and write reports that document the results. In addition, the presentation explains the FDA QSR and ISO 13485 regulatory requirements for process validation, and uses FDA Warning Letters to point out some of the problems that can occur.
An effective process validation program can help reduce cost. Validated processes can operate at optimized points – points that eliminate or reduce the amount of nonconforming material. The presentation illustrates the concepts of controlling the process parameters and testing them at challenge points. This approach helps set the process parameters at optimum levels.
Process validation is an integral part of any manufacturing system, but is especially important for medical devices, where regulations (FDA QSR and ISO 13485) lay out the requirements manufacturers must follow. It applies when a company cannot, or does not, perform 100% verification of the process output – the product. Since you cannot verify all of the product produced by the process, you need another way to ensure the process produces good output – process validation. Regulators often expect process validation when a manufacturer uses sampling plans for verification.
This presentation helps attendees understand how to perform process validation. Our speaker defines the concepts, and divides process validation into three phases: Installation Qualification (IQ), Operational Qualification (OQ), and Production Qualification (PQ). The presentation explains how to develop protocols for each phase and write reports that document the results. In addition, the presentation explains the FDA QSR and ISO 13485 regulatory requirements for process validation, and uses FDA Warning Letters to point out some of the problems that can occur.
An effective process validation program can help reduce cost. Validated processes can operate at optimized points – points that eliminate or reduce the amount of nonconforming material. The presentation illustrates the concepts of controlling the process parameters and testing them at challenge points. This approach helps set the process parameters at optimum levels.
Monday, March 22, 2010
Excel Spreadsheets and FDA Medical Device Regulations
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Thursday, April 29, 2010. For more details or to register, please visit our site at www.fxconferences.com
Excel spreadsheets can provide medical device manufacturers with valuable enhancements to production and quality systems. However, they must be implemented correctly and validated, and any records created must comply with FDA requirements.
When a device manufacturer uses an Excel spreadsheet, it must comply with two different parts of the FDA regulations. Following 21 CFR §820.70(i) Automated Processes, the manufacturer must validate the spreadsheets used in production or the quality system, and revalidate them when changes are made. Following 21 CFR Part 11, the manufacturer may also have created an electronic record. Device manufacturers must understand these regulations and the means to ensure compliance.
This presentation helps attendees understand the FDA device regulations related to Excel spreadsheets, beginning with methods to help ensure the spreadsheet produces the results you want. Our speaker explains how to use built-in validation tools, formula auditing and data, and also discusses the regulations for automated processes, found in 21 CFR §820.70(i), the requirements for a validation plan, and how to follow the FDA guidance document. The presentation also covers the electronic record aspects of the spreadsheet – requirements for electronic records and the issues raised, the current FDA guidance document, where FDA will exercise “regulatory discretion”, and what that means.
Excel spreadsheets can provide medical device manufacturers with valuable enhancements to production and quality systems. However, they must be implemented correctly and validated, and any records created must comply with FDA requirements.
When a device manufacturer uses an Excel spreadsheet, it must comply with two different parts of the FDA regulations. Following 21 CFR §820.70(i) Automated Processes, the manufacturer must validate the spreadsheets used in production or the quality system, and revalidate them when changes are made. Following 21 CFR Part 11, the manufacturer may also have created an electronic record. Device manufacturers must understand these regulations and the means to ensure compliance.
This presentation helps attendees understand the FDA device regulations related to Excel spreadsheets, beginning with methods to help ensure the spreadsheet produces the results you want. Our speaker explains how to use built-in validation tools, formula auditing and data, and also discusses the regulations for automated processes, found in 21 CFR §820.70(i), the requirements for a validation plan, and how to follow the FDA guidance document. The presentation also covers the electronic record aspects of the spreadsheet – requirements for electronic records and the issues raised, the current FDA guidance document, where FDA will exercise “regulatory discretion”, and what that means.
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