21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures (ER/ES) Used in Regulated Computer Systems
Master Industry Best Practices Related to Compliance and Computer System Validation!
Instructor :
Carolyn Troiano
Webinar ID:
4442
Date: 11 November 22, FRI
Start Time: 10 am PT
Duration: 90 Mins.
What you will learn
- 21 CFR Part 11 and what is required for compliance.
- Industry best practices related to compliance and computer system validation.
- Strategies for reducing the cost and complexity of compliance with FDA regulations
- How the SDLC methodology supports the computer system validation process.
- 21 CFR Part 11 and what is required for compliance.
- Industry best practices related to compliance and computer system validation.
- Strategies for reducing the cost and complexity of compliance with FDA regulations
- How the SDLC methodology supports the computer system validation process.
- Data Governance and Data Integrity, including the FDA’s Guidance issued in late 2018.
- What it takes to audit a vendor of hardware, software, components and services.
- How to gain information about trends in validation, as industry progresses and new best practices emerge.
Course Description
This webinar will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.
FDA’s 21 CFR Part 11 was enacted in the late 1990s, and implementation success across the pharmaceutical and other regulated industries has been mixed.
There are very specific limitations that arise when using ER/ES capability, such as eliminating print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
It also requires precise identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system.
Rules for changing passwords must be rigorously adhered to, and the passwords must be kept secure.
It is also critical that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result.
A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).
A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability.
These must clarify the 21 CFR Part 11 requirements and provide insight as to the way the company interprets its responsibility for meeting it.
As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt.
New technologies will continue to emerge that will change the way companies do business.
While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.
Join us to learn more…
This webinar will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.
FDA’s 21 CFR Part 11 was enacted in the late 1990s, and implementation success across the pharmaceutical and other regulated industries has been mixed.
There are very specific limitations that arise when using ER/ES capability, such as eliminating print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
It also requires precise identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system.
Rules for changing passwords must be rigorously adhered to, and the passwords must be kept secure.
It is also critical that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result.
A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).
A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability.
These must clarify the 21 CFR Part 11 requirements and provide insight as to the way the company interprets its responsibility for meeting it.
As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt.
New technologies will continue to emerge that will change the way companies do business.
While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.
Join us to learn more…
Why you should attend
This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.
This is critical to developing the appropriate validation strategy and achieving the thoroughness required to prove that a system does what it purports to do.
It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.
Enroll Now!
This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.
This is critical to developing the appropriate validation strategy and achieving the thoroughness required to prove that a system does what it purports to do.
It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.
Enroll Now!
Areas Covered
- Learn about 21 CFR Part 11 and what is required for compliance.
- Learn about industry best practices related to compliance and computer system validation.
- Understand strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11.
- Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process.
- Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state.
- Learn about Data Governance and Data Integrity, including the FDA’s Guidance issued in late 2018.
- Understand what it takes to audit a vendor of hardware, software, components and services.
- Learn how to gain information about trends in validation, as industry progresses and new best practices emerge.
- Understand some of the industry best practices to apply when following the SDLC methodology.
- Q&A
- Learn about 21 CFR Part 11 and what is required for compliance.
- Learn about industry best practices related to compliance and computer system validation.
- Understand strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11.
- Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process.
- Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state.
- Learn about Data Governance and Data Integrity, including the FDA’s Guidance issued in late 2018.
- Understand what it takes to audit a vendor of hardware, software, components and services.
- Learn how to gain information about trends in validation, as industry progresses and new best practices emerge.
- Understand some of the industry best practices to apply when following the SDLC methodology.
- Q&A
Who is this course for
- Information Technology (IT) Analysts
- IT Developers
- IT Support Staff
- QC/QA Managers and Analysts
- Manufacturing Personnel
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Supply Chain Personnel
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel….
- Information Technology (IT) Analysts
- IT Developers
- IT Support Staff
- QC/QA Managers and Analysts
- Manufacturing Personnel
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Supply Chain Personnel
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Consultants in the Life Sciences and Tobacco Industries
- Interns working at the companies listed above
- College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements
Instructor Profile
Carolyn Troiano has more than 40 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.
