Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation.
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.
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
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. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
During the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.
FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities by applying a sound, project management approach. Each validation effort includes a vast set of activities and tasks required to get the job done. These can be managed more effectively by better understanding how to apply a project management approach to them all, regardless of size.
In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended.
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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. throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAs a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThe 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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. throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThe Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsThe 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsThe Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThe seminar will focus on the importance of ensuring that the electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsCompanies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsIn addition to producing a Trial Master File (TMF), companies engaged in the conduct of human clinical trials must adhere to FDA’s requirements for Computer System Validation (CSV) and Data Integrity. In addition, they must adhere to specific government regulatory requirements. Certain documents, content, and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).
Speaker: Carolyn Troiano | View Anytime | Duration: 2 Days | Price: ¤1,045.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View DetailsFDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsIn particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsDuring the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsWe will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThis webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be dealt with at all levels to make sure the end product being used by a patient or consumer is perfectly safe and delivers the effective treatment required
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsWe will explore the latest best industry practices offered in GAMP®5 (Second Edition) and understand what it offers to those validation computer systems in the FDA-regulated industries. We will cover the changes and impact on validation as a result. We will also cover FDA’s recent draft guidance on Computer Software Assurance (CSA) and what that means in terms of how to approach validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View DetailsThere 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. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsWe will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsThere 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. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View DetailsDuring the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsFDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsWe will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities by applying a sound, project management approach. Each validation effort includes a vast set of activities and tasks required to get the job done. These can be managed more effectively by better understanding how to apply a project management approach to them all, regardless of size.
Speaker: Carolyn Troiano | View Anytime | Duration: 60 Minutes | Price: ¤199.00 | View DetailsIn particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsThe Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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. throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAs a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThe 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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. throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThe Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThe 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsThe Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤845.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤845.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThe seminar will focus on the importance of ensuring that the electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤845.00 | View DetailsCompanies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤845.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThis 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤549.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤845.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤845.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤845.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤549.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThe seminar 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsIn addition to producing a Trial Master File (TMF), companies engaged in the conduct of human clinical trials must adhere to FDA’s requirements for Computer System Validation (CSV) and Data Integrity. In addition, they must adhere to specific government regulatory requirements. Certain documents, content, and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).
Speaker: Carolyn Troiano | View Anytime | Duration: 2 Days | Price: ¤1,395.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤549.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤549.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View Details3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤549.00 | View DetailsFDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsIn particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsDuring the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsWe will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThis webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be dealt with at all levels to make sure the end product being used by a patient or consumer is perfectly safe and delivers the effective treatment required
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsWe will explore the latest best industry practices offered in GAMP®5 (Second Edition) and understand what it offers to those validation computer systems in the FDA-regulated industries. We will cover the changes and impact on validation as a result. We will also cover FDA’s recent draft guidance on Computer Software Assurance (CSA) and what that means in terms of how to approach validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤549.00 | View DetailsThere 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. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤549.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsWe will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsThere 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. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤549.00 | View DetailsDuring the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsFDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsWe will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities by applying a sound, project management approach. Each validation effort includes a vast set of activities and tasks required to get the job done. These can be managed more effectively by better understanding how to apply a project management approach to them all, regardless of size.
Speaker: Carolyn Troiano | View Anytime | Duration: 60 Minutes | Price: ¤399.00 | View DetailsIn particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤399.00 | View DetailsUpon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
Speaker: Carolyn Troiano | View Anytime | Duration: 4 Hours | Price: ¤845.00 | View Details