Trends in FDA Compliance and Enforcement for Regulated Systems

FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Best Practices in Preparation for an FDA Computer System Audit

FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

We 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 Details

Data Integrity and Privacy: 21 CFR Part 11, Annex 11, & General Data Protection Regulation (GDPR)

During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizen's personal data when they reside in the European Union (EU).

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & FDA Compliance

So what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far?

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Trial Master File (TMF)/eTMF, & FDA's Draft Guidance for Electronic Records/Signatures Used in Clinical Trials

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

GAMP®5, 2nd Edition & Alignment with FDA's Draft Guidance for Computer Software Assurance(CSA)

We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning Agile to the GAMP®5 "V" Model & System Development Life Cycle (SDLC)

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

FDA Compliance for Regulated Systems using COTS, Cloud, and SaaS Solutions

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View Details

Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

Upon 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: 90 Minutes | Price: ¤199.00 | View Details

Risk-Based Validation of Spreadsheet Applications

We will explore the best practices and strategic approach for evaluating Excel spreadsheets 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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Project Management for Computer System Validation (CSV) to Improve FDA Compliance

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Pharma 4.0 Focus - Newer Approaches and Technologies to Reduce Costs while Complying with FDA's 21 CFR Part 11, Data Integrity

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning Agile to the GAMP®5 "V" Model & System Development Life Cycle (SDLC)

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Project Management for Computer System Validation (CSV) to Improve FDA Compliance

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Data Integrity and Privacy: 21 CFR Part 11, Annex 11, & General Data Protection Regulation (GDPR)

During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizen's personal data when they reside in the European Union (EU).

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Risk-Based Validation of Spreadsheet Applications

We will explore the best practices and strategic approach for evaluating Excel spreadsheets 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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Data Integrity and Privacy: 21 CFR Part 11, Annex 11, & General Data Protection Regulation (GDPR)

During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizen's personal data when they reside in the European Union (EU).

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Trial Master File (TMF)/eTMF, & FDA's Draft Guidance for Electronic Records/Signatures used in Clinical Trials

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

GAMP®5, 2nd Edition & Alignment with FDA's Draft Guidance for Computer Software Assurance (CSA)

We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

FDA Compliance for Regulated Systems using COTS, Cloud, and SaaS Solutions

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Developing a Strategic Approach to FDA Compliance for Validation of Computer Systems

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The 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 Details

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon 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 Details

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The 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 Details

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon 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 Details

Trends in FDA Compliance and Enforcement for Regulated Systems

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Data Integrity and Privacy: 21 CFR Part 11, Annex 11, & General Data Protection Regulation (GDPR)

During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizens’ personal data when they reside in the European Union (EU).

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Trial Master File (TMF)/eTMF, & FDA's Draft Guidance for Electronic Records/Signatures Used in Clinical Trials

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

GAMP®5, 2nd Edition & Alignment with FDA's Draft Guidance for Computer Software Assurance(CSA)

We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The 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 Details

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon 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 Details

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The 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 Details

Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance

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 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 Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View Details

3-Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

GAMP5, Second Edition and Alignment with Computer Software Assurance (CSA) and Digital Validation

We 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 Details

Medical Device Cybersecurity - FDA Guidance for Quality System Considerations and Content of Premarket Submissions

This 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 Details

Vendor Audit - Focus on Cloud, Software-as-a-Service (SaaS), and Other Technologies used for FDA-Regulated Activities

We 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 Details

Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance

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 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 Details

Pharma 4.0 Focus - Newer Approaches and Technologies to Reduce Costs while Complying with FDA's 21 CFR Part 11, Data Integrity

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. 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 Details

3-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 Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

Upon 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 Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

3-Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

3-Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

2-Day Virtual Seminar on Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA

In 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 Details

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The 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 Details

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon 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 Details

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

Upon 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 Details

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon 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 Details

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The 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 Details

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon 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 Details

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The 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 Details

Computer System Validation (CSV) and Computer Software Assurance (CSA): Future Trends in Validation

Advancements 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 Details

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

3-Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: ¤349.00 | View Details

Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

Upon 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 Details

Computer System Validation (CSV) and Computer Software Assurance (CSA): Future Trends in Validation

Advancements 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 Details

Medical Device Cybersecurity and FDA Compliance

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The 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 Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon 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 Details

Computer System Validation (CSV) and Computer Software Assurance (CSA): Future Trends in Validation

Advancements 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 Details

Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)

Companies 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 Details

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon 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 Details

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The 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 Details

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

4-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The 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 Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

4-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The 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 Details

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The 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 Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Medical Device Cybersecurity and FDA Compliance

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon 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 Details

Medical Device Software Cybersecurity and IEC 62304 Compliance

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Medical Device Cybersecurity and FDA Compliance

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon 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 Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Medical Device Software Cybersecurity and IEC 62304 Compliance

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Computer System Validation (CSV) for FDA-Regulated Computers

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 Details

6-Hour Virtual Seminar on 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.

Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View Details

6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon 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 Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Computer System Validation (CSV) for FDA-Regulated Computers

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 Details

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Medical Device Software Cybersecurity and IEC 62304 Compliance

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon 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 Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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. throughout their entire life cycle.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Medical Device Software Cybersecurity and IEC 62304 Compliance

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

6-Hour Virtual Seminar on 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.

Speaker: Carolyn Troiano | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View Details

How Will FDA's New Approach to CSV Make Implementations Easier?

Advancements 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 Details

Best Practices in Preparation for an FDA Computer System Audit

As 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 Details

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Medical Device Cybersecurity and FDA Compliance

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.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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. throughout their entire life cycle.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details

Computer System Validation (CSV) for FDA-Regulated Computers

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 Details