From Compliance Chaos to Crystal Clarity: Mastering 21 CFR Part 11 for FDA-Regulated Computer Systems
Unlock Compliance Mastery – Ensure Your Systems Meet FDA Standards Effortlessly!
Instructor :
Carolyn Troiano
Webinar ID:
8815
Date: MAY 01, 2024 (WED)
Start Time: 08 AM PT - 02 PM PT
Duration: 6 Hrs.
What you will learn
- Interpreting the FDA’s Expectations for 21 CFR Part 11 Compliance
- Navigating FDA Regulatory Oversight & Computer System Validation
- System Development Life Cycle (SDLC) Methodology
- GAMP 5 Software Categorization…
- Interpreting the FDA’s Expectations for 21 CFR Part 11 Compliance
- Navigating FDA Regulatory Oversight & Computer System Validation
- System Development Life Cycle (SDLC) Methodology
- GAMP 5 Software Categorization
- System Risk Assessment
- Ensuring 21 CFR Part 11 Compliance & Secure Data Management
- Security, Access, Change Control, and Audit Trail
- Identifying Common Validation Issues & Preparing for FDA Audit
- Establishing Effective Policies, Training, Latest Trends, Best Practices, and Common Pitfalls
Course Description
- Do you find it difficult to stay updated with ever-changing FDA regulations, especially the complex 21 CFR Part 11?
- Are you constantly concerned about fulfilling all requirements and passing increasingly stringent FDA audits?
- Does the potential for hefty penalties or product recalls due to non-compliance cause you stress?
- Is it a challenge to determine which systems are regulated and how to validate them?
- Do you struggle with educating your team on these regulations’ importance, non-compliance penalties, and compliance assurance?
- Does technical jargon related to system compliance impede your effective communication with Quality Assurance, IT, and compliance teams, particularly as a non-technical person?
” If your answer is ‘yes‘ to any of the above questions, then this training is exactly what you need – Don’t miss this opportunity to alleviate your concerns and enhance your understanding of FDA regulations, specifically 21 CFR Part 11. “
This training is meticulously designed to unravel the complex guidelines under the FDA’s 21 CFR Part 11 regulation, the federal rule on electronic records and electronic signatures in the United States.
” Focused on the realm of computer systems, this seminar ensures that your organization can effectively navigate through the FDA’s rules, mitigating risks of non-compliance and confidently establishing robust electronic record-keeping systems. “
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.
This includes the development of a company philosophy and approach and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
Navigating FDA’s 21 CFR Part 11 has proven challenging for regulated industries.
- The rule demands strict security protocols, secure passwords, and rigorous password change rules.
- It requires clear user identification and a well-defined electronic signature process, ensuring segregation of duties – recorders shouldn’t be reviewers or approvers.
- Organizations must establish robust policies and procedures, reflecting their clear understanding of their responsibilities under the rule.
As regulatory landscapes evolve and new technologies emerge, these can introduce complex oversight layers, intensifying system validation, and challenging cost-benefit balance. Thus, a nuanced understanding of 21 CFR Part 11 is crucial for successful adaptation.
This comprehensive training is meticulously designed by industry expert, Carolyn Troiano, to equip you with the essential knowledge and practical strategies to ensure seamless compliance with the stringent regulations set by the FDA.
Join Now!
- Do you find it difficult to stay updated with ever-changing FDA regulations, especially the complex 21 CFR Part 11?
- Are you constantly concerned about fulfilling all requirements and passing increasingly stringent FDA audits?
- Does the potential for hefty penalties or product recalls due to non-compliance cause you stress?
- Is it a challenge to determine which systems are regulated and how to validate them?
- Do you struggle with educating your team on these regulations’ importance, non-compliance penalties, and compliance assurance?
- Does technical jargon related to system compliance impede your effective communication with Quality Assurance, IT, and compliance teams, particularly as a non-technical person?
” If your answer is ‘yes‘ to any of the above questions, then this training is exactly what you need – Don’t miss this opportunity to alleviate your concerns and enhance your understanding of FDA regulations, specifically 21 CFR Part 11. “
This training is meticulously designed to unravel the complex guidelines under the FDA’s 21 CFR Part 11 regulation, the federal rule on electronic records and electronic signatures in the United States.
” Focused on the realm of computer systems, this seminar ensures that your organization can effectively navigate through the FDA’s rules, mitigating risks of non-compliance and confidently establishing robust electronic record-keeping systems. “
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.
This includes the development of a company philosophy and approach and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
Navigating FDA’s 21 CFR Part 11 has proven challenging for regulated industries.
- The rule demands strict security protocols, secure passwords, and rigorous password change rules.
- It requires clear user identification and a well-defined electronic signature process, ensuring segregation of duties – recorders shouldn’t be reviewers or approvers.
- Organizations must establish robust policies and procedures, reflecting their clear understanding of their responsibilities under the rule.
As regulatory landscapes evolve and new technologies emerge, these can introduce complex oversight layers, intensifying system validation, and challenging cost-benefit balance. Thus, a nuanced understanding of 21 CFR Part 11 is crucial for successful adaptation.
This comprehensive training is meticulously designed by industry expert, Carolyn Troiano, to equip you with the essential knowledge and practical strategies to ensure seamless compliance with the stringent regulations set by the FDA.
Join Now!
Why you should attend
“Stay Ahead of FDA Regulatory Requirements – In an era where digitalization is king, non-compliance with 21 CFR Part 11 can result in costly corrective measures and penalties, not to mention reputational damage that can impede your competitive position.”
Statistically, FDA warning letters citing 21 CFR Part 11 issues have surged by 8% in the last two years. Ignorance is no longer bliss – it’s a ticking time bomb.
FDA requires that all computer systems that handle data regulated by the Agency be validated in accordance with their guidance on computerized systems.
This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technological changes that have taken place
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 in order to develop the appropriate validation strategy and achieve 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.
- ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.
Attend this seminar to equip yourself with the knowledge to identify, address, and avoid potential pitfalls, while ensuring your digital records’ integrity, reliability, and legal compliance.
Enroll Now!
“Stay Ahead of FDA Regulatory Requirements – In an era where digitalization is king, non-compliance with 21 CFR Part 11 can result in costly corrective measures and penalties, not to mention reputational damage that can impede your competitive position.”
Statistically, FDA warning letters citing 21 CFR Part 11 issues have surged by 8% in the last two years. Ignorance is no longer bliss – it’s a ticking time bomb.
FDA requires that all computer systems that handle data regulated by the Agency be validated in accordance with their guidance on computerized systems.
This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technological changes that have taken place
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 in order to develop the appropriate validation strategy and achieve 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.
- ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.
Attend this seminar to equip yourself with the knowledge to identify, address, and avoid potential pitfalls, while ensuring your digital records’ integrity, reliability, and legal compliance.
Enroll Now!
Areas Covered
Session 1 (90 Mins): Navigating FDA Regulatory Oversight & Computer System Validation
- FDA Regulatory Oversight
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
- GAMP 5 Software Categorization
- System Risk Assessment
Session 2 (90 Mins): Ensuring 21 CFR Part 11 Compliance & Secure Data Management
- 21 CFR Part 11 Compliance (Electronic Records/Electronic Signatures)
- Security, Access, Change Control, and Audit Trail
- Validation Documentation
Session 3 (90 Mins): Identifying Common Validation Issues & Preparing for FDA Audit
- 7 Most Common Problems with Validation
- FDA Audit Preparation
Session 4 (90 Mins): Establishing Effective Policies, Training, and Best Practices
- Policies and Procedures
- Training and Organizational Change Management
- Industry Best Practices and Common Pitfalls
- Q&A
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.
Session 1 (90 Mins): Navigating FDA Regulatory Oversight & Computer System Validation
- FDA Regulatory Oversight
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
- GAMP 5 Software Categorization
- System Risk Assessment
Session 2 (90 Mins): Ensuring 21 CFR Part 11 Compliance & Secure Data Management
- 21 CFR Part 11 Compliance (Electronic Records/Electronic Signatures)
- Security, Access, Change Control, and Audit Trail
- Validation Documentation
Session 3 (90 Mins): Identifying Common Validation Issues & Preparing for FDA Audit
- 7 Most Common Problems with Validation
- FDA Audit Preparation
Session 4 (90 Mins): Establishing Effective Policies, Training, and Best Practices
- Policies and Procedures
- Training and Organizational Change Management
- Industry Best Practices and Common Pitfalls
- Q&A
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!
- Quality Assurance Managers
- IT Managers
- Regulatory Affairs Specialists
- Compliance Managers
- Validation Specialists/Managers
- Clinical Operations Managers
- Data Managers in Clinical Trials
- Computer System Validation Specialists
- Quality Control Managers
- Business Analysts in FDA-Regulated Industries
- Clinical Research Coordinators
- Regulatory Compliance Officers
- Process Validation Managers
- Validation Engineers
- Technology Transfer Specialists in Life Sciences
- Document Control Managers
- Clinical Trial Associates
- Clinical Site Managers/Investigators
- Laboratory Managers in FDA-Regulated Labs
- GMP Compliance Managers
Maximize The Learning Experience in A Group Setting!
- Quality Assurance Managers
- IT Managers
- Regulatory Affairs Specialists
- Compliance Managers
- Validation Specialists/Managers
- Clinical Operations Managers
- Data Managers in Clinical Trials
- Computer System Validation Specialists
- Quality Control Managers
- Business Analysts in FDA-Regulated Industries
- Clinical Research Coordinators
- Regulatory Compliance Officers
- Process Validation Managers
- Validation Engineers
- Technology Transfer Specialists in Life Sciences
- Document Control Managers
- Clinical Trial Associates
- Clinical Site Managers/Investigators
- Laboratory Managers in FDA-Regulated Labs
- GMP Compliance Managers
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.
