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.
Showing posts with label qsr. Show all posts
Showing posts with label qsr. Show all posts
Thursday, June 2, 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, 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.
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, 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.
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.
Tuesday, May 26, 2009
Implementing GMP for Combination Products: What Applies When?
Combination product manufacturers are faced with a major challenge to implement a quality system that complies with applicable FDA Good Manufacturing Practices (GMPs) and Quality System Requirements (QSRs). For 10 years, FDA has been progressively developing regulations for this complex area, yet has provided very few formal guidance documents to help manufacturers.
In this audio conference, you learn how to navigate the regulations to develop effective plans for combination products. Linda Alexander gives you specific examples of current FDA expectations and accepted practices, and teaches you how to customize and apply them to comply. Explore the history of combination approvals in the US, case studies, and important trends and issues for the future.
Implementing GMP for Combination Products: What Applies When? was presented by Linda Alexander, CEO and Founder, with Alquest and aired on 2008-09-18. For more details or to download this conference, please visit our site at www.fxconferences.com
In this audio conference, you learn how to navigate the regulations to develop effective plans for combination products. Linda Alexander gives you specific examples of current FDA expectations and accepted practices, and teaches you how to customize and apply them to comply. Explore the history of combination approvals in the US, case studies, and important trends and issues for the future.
Implementing GMP for Combination Products: What Applies When? was presented by Linda Alexander, CEO and Founder, with Alquest and aired on 2008-09-18. For more details or to download this conference, please visit our site at www.fxconferences.com
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