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 21CFR 820. Show all posts
Showing posts with label 21CFR 820. 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.
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.
Friday, May 28, 2010
A Common Sense Approach to FDA and ISO Compliance
is being presented by Susan Soderholm, Quality Manager & Certified Quality Auditor, Amcor Rigid Plastics and airs on Tuesday, June 29th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Regulatory agencies are 'upping the ante' with regards to implied and written compliance. As they currently exist, the ICH guidance documents may or may not be issued. Our global marketplace makes it critical to understand the linkages between FDA, ISO and ICH requirements to have a quality system that meets all requirements in the broad customer base – in particular, 21CFR211/820, ISO 13485, ISO 9001 and ICH Q8, Q9, Q10 and IPEC 2006 requirements, similarities and differences.
Preparation for a successful audit, product approval and a compliant Quality Management System is key to compliance and ultimately, product and site approval. In this audio conference, our speaker draws on extensive experience in hosting regulatory agency and customer audits, as she shares practical experience and established best practice approaches.
Regulatory agencies are 'upping the ante' with regards to implied and written compliance. As they currently exist, the ICH guidance documents may or may not be issued. Our global marketplace makes it critical to understand the linkages between FDA, ISO and ICH requirements to have a quality system that meets all requirements in the broad customer base – in particular, 21CFR211/820, ISO 13485, ISO 9001 and ICH Q8, Q9, Q10 and IPEC 2006 requirements, similarities and differences.
Preparation for a successful audit, product approval and a compliant Quality Management System is key to compliance and ultimately, product and site approval. In this audio conference, our speaker draws on extensive experience in hosting regulatory agency and customer audits, as she shares practical experience and established best practice approaches.
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.
Friday, November 6, 2009
Friday special - save 75% on "GCP for Medical Device Trials: Upcoming Revisions to ISO 14155"
An important standard for conducting medical device research is changing. How will it affect you?
Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - Parts 1 and 2) is currently under revision.
This audio conference focuses on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. This presentation reviews the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.
Participants also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Parts 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker also provides attendees with an essential clinical investigation document checklist.
But hurry! If you purchase GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 by November 12, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.
Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - Parts 1 and 2) is currently under revision.
This audio conference focuses on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. This presentation reviews the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.
Participants also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Parts 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker also provides attendees with an essential clinical investigation document checklist.
But hurry! If you purchase GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 by November 12, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.
Thursday, January 15, 2009
GCP for Medical Device Trials: Upcoming Revisions to ISO 14155
An important standard for conducting medical device research is changing. How will it affect you?
Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - part 1 and 2) is currently under revision. This audio conference will focus on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. The presentation will review the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.
Participants will also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Part 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker will also provide attendees with an essential clinical investigation document checklist.
GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 is being presented by Carol Houts, Director of Regulatory, Quality & Safety, with Pleiad, Inc. and airs on Thursday, February 26th, 2009. For more details or to register please visit our site www.fxconferences.com
This audio conference has been pre-approved by RAPS as eligible for one credit toward a participant's RAC recertification upon completion.
Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - part 1 and 2) is currently under revision. This audio conference will focus on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. The presentation will review the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.
Participants will also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Part 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker will also provide attendees with an essential clinical investigation document checklist.
GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 is being presented by Carol Houts, Director of Regulatory, Quality & Safety, with Pleiad, Inc. and airs on Thursday, February 26th, 2009. For more details or to register please visit our site www.fxconferences.com
This audio conference has been pre-approved by RAPS as eligible for one credit toward a participant's RAC recertification upon completion.
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