• Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Carolyn Troiano
    FDA Compliance and Mobile Applications
    This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to FDA and/or must be available for FDA review upon inspection or audit. Mobile applications may be used in any area of an FDA-regulated company. Functional areas where FDA-regulated data is typically processed include, but are not limited to Quality Laboratories, Manufacturing, Supply Chain/Distribution, Adverse Event Reporting, Post-Marketing Surveillance. Systems may also be used to monitor and/or control FDA-regulated processes and equipment, handle product labeling, product lot control, clinical trial and trial sample management, and many other processes.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤390.00
    by: Carolyn Troiano
    FDA Compliance and Mobile Applications
    This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to FDA and/or must be available for FDA review upon inspection or audit. Mobile applications may be used in any area of an FDA-regulated company. Functional areas where FDA-regulated data is typically processed include, but are not limited to Quality Laboratories, Manufacturing, Supply Chain/Distribution, Adverse Event Reporting, Post-Marketing Surveillance. Systems may also be used to monitor and/or control FDA-regulated processes and equipment, handle product labeling, product lot control, clinical trial and trial sample management, and many other processes.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Carolyn Troiano
    21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤390.00
    by: Carolyn Troiano
    21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Carolyn Troiano
    FDA's New Draft Guidance on Software and Device Changes and the 510(k)
    The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company's decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary. The flowcharts address changes to:

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤390.00
    by: Carolyn Troiano
    FDA's New Draft Guidance on Software and Device Changes and the 510(k)
    The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company's decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary. The flowcharts address changes to:

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Carolyn Troiano
    Good Documentation Practices to Support FDA Computer System Validation
    As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤390.00
    by: Carolyn Troiano
    Good Documentation Practices to Support FDA Computer System Validation
    As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Carolyn Troiano
    Computer System Validation (CSV) for FDA-Regulated Computers
    FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤390.00
    by: Carolyn Troiano
    Computer System Validation (CSV) for FDA-Regulated Computers
    FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Carolyn Troiano
    21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤390.00
    by: Carolyn Troiano
    21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤390.00
    by: Carolyn Troiano
    FDA Compliance and Mobile Applications
    This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to FDA and/or must be available for FDA review upon inspection or audit. Mobile applications may be used in any area of an FDA-regulated company. Functional areas where FDA-regulated data is typically processed include, but are not limited to Quality Laboratories, Manufacturing, Supply Chain/Distribution, Adverse Event Reporting, Post-Marketing Surveillance.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:3 Hours
    Price: ¤340.00
    by: Carolyn Troiano
    3-Hour Virtual Seminar Computer System Validation (CSV) for FDA-Regulated Computers
    FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:3 Hours
    Price: ¤540.00
    by: Carolyn Troiano
    3-Hour Virtual Seminar Computer System Validation (CSV) for FDA-Regulated Computers
    FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Carolyn Troiano
    FDA's New Draft Guidance on Software and Device Changes and the 510(k)
    A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤390.00
    by: Carolyn Troiano
    FDA's New Draft Guidance on Software and Device Changes and the 510(k)
    A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:3 Hours
    Price: ¤340.00
    by: Carolyn Troiano
    3-Hour Virtual Seminar on In-Depth Computer System Validation (CSV) for FDA Compliance
    This 3-Hour webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, and You'll learn about the various computer system.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:3 Hours
    Price: ¤540.00
    by: Carolyn Troiano
    3-Hour Virtual Seminar on In-Depth Computer System Validation (CSV) for FDA Compliance
    This 3-Hour webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, and You'll learn about the various computer system.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Carolyn Troiano
    Current Trends in CyberSecurity Threats to Medical Devices
    This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤390.00
    by: Carolyn Troiano
    Current Trends in CyberSecurity Threats to Medical Devices
    This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Carolyn Troiano
    Trends for Computer System Validation (CSV), Medical Device Compliance and FDA Enforcement
    This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems.

  • Carolyn Troiano Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤390.00
    by: Carolyn Troiano
    Trends for Computer System Validation (CSV), Medical Device Compliance and FDA Enforcement
    This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems.

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Fremont, CA 94539, USA.

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