How to Go Paperless in an FDA-Regulated Environment Using Electronic Workflow Signature Approvals and Electronic Records
Understand The Critical Elements That Make or Break Successful Digital Transformation in Regulated Environments!
Instructor :
Carolyn Troiano
Webinar ID:
10817
Date: FEB 07, 2025 (FRI)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
-
- Explore FDA’s 21 CFR Part 11 for Electronic Records, Signatures.
- Discuss Pros and Cons of Electronic Records/Signatures Capabilities.
- Analyze Cost-Benefit of Implementing Electronic Records/Signatures.
- Utilize System Development Life Cycle for Validation Processes.
- Identify Risks and Mitigation for Electronic Records/Signatures Implementation.
- Address Organizational Change Management for …
-
- Explore FDA’s 21 CFR Part 11 for Electronic Records, Signatures.
- Discuss Pros and Cons of Electronic Records/Signatures Capabilities.
- Analyze Cost-Benefit of Implementing Electronic Records/Signatures.
- Utilize System Development Life Cycle for Validation Processes.
- Identify Risks and Mitigation for Electronic Records/Signatures Implementation.
- Address Organizational Change Management for Successful ER/ES Integration.
- Define Key Roles in Implementing and Supporting ER/ES Systems.
- Integrate Electronic Records/Signatures in Existing Applications Effectively.
Prepare for FDA Audits Focused on ER/ES Applications
Course Description
In this comprehensive webinar, participants will delve into the critical requirements of 21 CFR Part 11, focusing on the FDA regulations for electronic records and electronic signatures (ER/ES).
Here’s what you can expect to learn:
-
- Essentials of ER/ES: Understand the foundational concepts of using electronic records and signatures, ensuring your company meets the stringent requirements set by the FDA.
- Implementing Paperless Systems: Discover the best practices for transitioning to a paperless environment, where business processes are streamlined through software-enabled workflows.
- Navigating Software-Enabled Workflow Systems: Gain insights into setting up workflows that efficiently route documents to authorized signatories, incorporating mechanisms for tracking document status and approval stages.
- Enhancing Document Security: Learn how to establish robust security protocols and access rights, ensuring that every electronic signature is authenticated effectively.
- Handling Rejections and Modifications: Master the procedures for managing document rejections, including withdrawal requests or necessary modifications to maintain compliance.
By embracing these technologies, your organization can achieve a seamless and compliant paperless operation.
Join us to empower your team with the knowledge to implement and manage these critical systems effectively.
Enroll Now!
In this comprehensive webinar, participants will delve into the critical requirements of 21 CFR Part 11, focusing on the FDA regulations for electronic records and electronic signatures (ER/ES).
Here’s what you can expect to learn:
-
- Essentials of ER/ES: Understand the foundational concepts of using electronic records and signatures, ensuring your company meets the stringent requirements set by the FDA.
- Implementing Paperless Systems: Discover the best practices for transitioning to a paperless environment, where business processes are streamlined through software-enabled workflows.
- Navigating Software-Enabled Workflow Systems: Gain insights into setting up workflows that efficiently route documents to authorized signatories, incorporating mechanisms for tracking document status and approval stages.
- Enhancing Document Security: Learn how to establish robust security protocols and access rights, ensuring that every electronic signature is authenticated effectively.
- Handling Rejections and Modifications: Master the procedures for managing document rejections, including withdrawal requests or necessary modifications to maintain compliance.
By embracing these technologies, your organization can achieve a seamless and compliant paperless operation.
Join us to empower your team with the knowledge to implement and manage these critical systems effectively.
Enroll Now!
Why you should attend
This webinar is designed to equip attendees with the knowledge and skills needed to develop and maintain electronic records and signatures (ER/ES) in a FDA-regulated environment.
Here’s what you will learn:
-
- Standardizing ER/ES Processes: Explore a standard approach to deploying ER/ES systems that handle records and approvals seamlessly.
- Best Practices for Paperless Operations: Understand the crucial best practices and considerations before transitioning to a paperless environment.
- Advantages and Drawbacks: We will delve into the pros and cons of using ER/ES, helping you understand the broader implications of adopting this technology.
- Compliance and Implementation: Equip yourself to make informed decisions about applying ER/ES in your workplace and maintaining compliance with FDA regulations.
- Security Measures and Emerging Technologies: Learn about the latest technologies and security measures critical to meeting the requirements of FDA’s 21 CFR Part 11.
- Risk Mitigation: Discuss the potential threats and challenges associated with ER/ES and discover strategies to mitigate these risks.
- Operational Efficiency: Identify opportunities to reduce compliance costs and enhance operational efficiency and effectiveness through the adoption of ER/ES.
Gain a comprehensive understanding of how to implement and sustain ER/ES effectively, ensuring your processes are both compliant and optimized for today’s digital landscape.
Join Now!
This webinar is designed to equip attendees with the knowledge and skills needed to develop and maintain electronic records and signatures (ER/ES) in a FDA-regulated environment.
Here’s what you will learn:
-
- Standardizing ER/ES Processes: Explore a standard approach to deploying ER/ES systems that handle records and approvals seamlessly.
- Best Practices for Paperless Operations: Understand the crucial best practices and considerations before transitioning to a paperless environment.
- Advantages and Drawbacks: We will delve into the pros and cons of using ER/ES, helping you understand the broader implications of adopting this technology.
- Compliance and Implementation: Equip yourself to make informed decisions about applying ER/ES in your workplace and maintaining compliance with FDA regulations.
- Security Measures and Emerging Technologies: Learn about the latest technologies and security measures critical to meeting the requirements of FDA’s 21 CFR Part 11.
- Risk Mitigation: Discuss the potential threats and challenges associated with ER/ES and discover strategies to mitigate these risks.
- Operational Efficiency: Identify opportunities to reduce compliance costs and enhance operational efficiency and effectiveness through the adoption of ER/ES.
Gain a comprehensive understanding of how to implement and sustain ER/ES effectively, ensuring your processes are both compliant and optimized for today’s digital landscape.
Join Now!
Course Agenda
Understanding FDA’s 21 CFR Part 11:
-
- Dive into the guidance for electronic records and signatures to ensure full compliance.
Evaluating ER/ES:
-
- Discuss the pros and cons of implementing ER/ES capabilities within your organization.
Cost-Benefit Analysis:
-
- Conduct a thorough analysis to assess the financial implications of adopting ER/ES capabilities.
SDLC for ER/ES:
-
- Explore the System Development Life Cycle (SDLC) approach crucial for validating ER/ES systems.
Risk Management:
-
- Identify potential risks associated with ER/ES implementation and learn effective mitigation strategies.
Change Management:
-
- Understand the organizational changes necessary to successfully implement and utilize ER/ES capabilities.
Roles and Responsibilities:
-
- Define key roles and responsibilities involved in the setup, use, and support of ER/ES-enabled systems.
Integration Strategies:
-
- Learn how to integrate ER/ES capabilities seamlessly with existing applications.
Documenting ER/ES Rationalization:
-
- Gain insights into the documentation processes required for rationalizing ER/ES usage.
FDA Audit Preparedness:
-
- Prepare for FDA audits that focus on applications utilizing ER/ES capabilities.
Real-World Case Studies:
-
- Review examples from companies that have implemented ER/ES, discussing their rationale, cost-benefit analysis, risk assessments, and the outcomes achieved.
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Understanding FDA’s 21 CFR Part 11:
-
- Dive into the guidance for electronic records and signatures to ensure full compliance.
Evaluating ER/ES:
-
- Discuss the pros and cons of implementing ER/ES capabilities within your organization.
Cost-Benefit Analysis:
-
- Conduct a thorough analysis to assess the financial implications of adopting ER/ES capabilities.
SDLC for ER/ES:
-
- Explore the System Development Life Cycle (SDLC) approach crucial for validating ER/ES systems.
Risk Management:
-
- Identify potential risks associated with ER/ES implementation and learn effective mitigation strategies.
Change Management:
-
- Understand the organizational changes necessary to successfully implement and utilize ER/ES capabilities.
Roles and Responsibilities:
-
- Define key roles and responsibilities involved in the setup, use, and support of ER/ES-enabled systems.
Integration Strategies:
-
- Learn how to integrate ER/ES capabilities seamlessly with existing applications.
Documenting ER/ES Rationalization:
-
- Gain insights into the documentation processes required for rationalizing ER/ES usage.
FDA Audit Preparedness:
-
- Prepare for FDA audits that focus on applications utilizing ER/ES capabilities.
Real-World Case Studies:
-
- Review examples from companies that have implemented ER/ES, discussing their rationale, cost-benefit analysis, risk assessments, and the outcomes achieved.
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Who is this course for
Maximize the Learning Experience in A Group Setting!
- 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
- Software Development Companies and Personnel (develop software for the medical device industry)
- Consultants in the Life Sciences and Tobacco Industries
Maximize the Learning Experience in A Group Setting!
- 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
- Software Development Companies and Personnel (develop software for the medical device industry)
- Consultants in the Life Sciences and Tobacco Industries
Instructor Profile
Carolyn (McKillop) 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. 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.
