Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
Elevate Your Compliance Strategy: Risk-Smart, FDA-Ready!
Instructor :
Carolyn Troiano
Webinar ID:
9708
Date: 6 March 24, WED
Start Time: 10 am PT
Duration: 90 Mins.
What you will learn
- 21 CFR Part 11 Insights: Key compliance essentials.
- Compliance Best Practices: Standards for system validation.
- Efficient FDA Compliance: Cost-reduction strategies.
- SDLC in Validation: Enhancing validation processes.
- Documenting Validation: Techniques for maintaining systems.
- Data Governance & Integrity: Overview of …
- 21 CFR Part 11 Insights: Key compliance essentials.
- Compliance Best Practices: Standards for system validation.
- Efficient FDA Compliance: Cost-reduction strategies.
- SDLC in Validation: Enhancing validation processes.
- Documenting Validation: Techniques for maintaining systems.
- Data Governance & Integrity: Overview of FDA’s 2018 guidance.
- Vendor Audit Skills: Effective vendor evaluation methods.
- Validation Trends: Updates on emerging best practices.
- SDLC Excellence: Key practices for successful implementation
Course Description
Did You Know? In 1997, the FDA revolutionized the way we handle Electronic Records and Signatures (ER/ES), rolling out guidelines via 21 CFR Part 11. But, how does this impact systems in an FDA-regulated environment?
Shift to Self-Regulation: By the early 2000s, the FDA pivoted, realizing inspections of every computer system at every regulated company were impossible. Did they place the responsibility on the industry itself? Absolutely!
Now, each company must assess their computer systems based on risk. But what factors determine this risk-based validation approach?
Five Key Components: System size, complexity, business criticality, GAMP 5 category, and risk rating. Do you know how these elements dictate the scope and robustness of testing needed for data integrity and product safety?
FDA’s Intensified Focus: Recently, the FDA has zoomed in on data integrity during system validation inspections and audits. Why is this crucial for compliance? Because it encompasses all systems that “touch” products, including databases, documents, spreadsheets, and even multimedia files. How are you managing and maintaining their integrity throughout their life cycle?
Carolyn Troiano’s Insights: In this interactive course on Information Technology, major areas are covered:
- Identifying “GxP” Systems: How can you spot them?
- The CSV Approach: What are FDA’s requirements?
- SDLC in Validation: Why is this methodology key?
- Documenting Validation Efforts: How to ensure your documentation stands up to scrutiny?
- Maintaining Validated Systems: How do you keep them compliant throughout their life cycle?
- Assuring Data Integrity: What’s the best way to support GxP work?
- “GxP” Documentation Compliance: Why is this non-negotiable with the FDA?
- Supporting Policies and Procedures: How do they bolster your validation process?
- 21 CFR Part 11 Compliance: What are the must-know components for electronic records and signatures?
- Understanding FDA’s Current Thinking: How do regulatory influences shape this?
- Risk Assessment: How does it form the foundation of your validation rationale?
- Assessing System Risks: How do size, complexity, and other factors play into this?
- Risk Management Strategies: What controls can minimize risk?
- FDA Inspection Prep: How can you be best prepared?
- Vendor Audit Importance: Why is thorough vendor auditing critical?
- Industry Best Practices: How can you optimize your approach to validation and compliance?
Enroll Now!
Did You Know? In 1997, the FDA revolutionized the way we handle Electronic Records and Signatures (ER/ES), rolling out guidelines via 21 CFR Part 11. But, how does this impact systems in an FDA-regulated environment?
Shift to Self-Regulation: By the early 2000s, the FDA pivoted, realizing inspections of every computer system at every regulated company were impossible. Did they place the responsibility on the industry itself? Absolutely!
Now, each company must assess their computer systems based on risk. But what factors determine this risk-based validation approach?
Five Key Components: System size, complexity, business criticality, GAMP 5 category, and risk rating. Do you know how these elements dictate the scope and robustness of testing needed for data integrity and product safety?
FDA’s Intensified Focus: Recently, the FDA has zoomed in on data integrity during system validation inspections and audits. Why is this crucial for compliance? Because it encompasses all systems that “touch” products, including databases, documents, spreadsheets, and even multimedia files. How are you managing and maintaining their integrity throughout their life cycle?
Carolyn Troiano’s Insights: In this interactive course on Information Technology, major areas are covered:
- Identifying “GxP” Systems: How can you spot them?
- The CSV Approach: What are FDA’s requirements?
- SDLC in Validation: Why is this methodology key?
- Documenting Validation Efforts: How to ensure your documentation stands up to scrutiny?
- Maintaining Validated Systems: How do you keep them compliant throughout their life cycle?
- Assuring Data Integrity: What’s the best way to support GxP work?
- “GxP” Documentation Compliance: Why is this non-negotiable with the FDA?
- Supporting Policies and Procedures: How do they bolster your validation process?
- 21 CFR Part 11 Compliance: What are the must-know components for electronic records and signatures?
- Understanding FDA’s Current Thinking: How do regulatory influences shape this?
- Risk Assessment: How does it form the foundation of your validation rationale?
- Assessing System Risks: How do size, complexity, and other factors play into this?
- Risk Management Strategies: What controls can minimize risk?
- FDA Inspection Prep: How can you be best prepared?
- Vendor Audit Importance: Why is thorough vendor auditing critical?
- Industry Best Practices: How can you optimize your approach to validation and compliance?
Enroll Now!
Why you should attend
Why Attend This Course? It’s not just about compliance; it’s about staying ahead in an evolving regulatory environment.
Are you ready to ensure your systems and data management strategies are not just compliant but exemplary? 🌟
Join Now!
Why Attend This Course? It’s not just about compliance; it’s about staying ahead in an evolving regulatory environment.
Are you ready to ensure your systems and data management strategies are not just compliant but exemplary? 🌟
Join Now!
Course Agenda
- 21 CFR Part 11 Compliance: Understand essential compliance requirements.
- Industry Compliance Best Practices: Explore top standards in system validation.
- Streamlining FDA Compliance: Learn cost-effective, simpler compliance strategies.
- SDLC Methodology: Explain how it bolsters computer system validation.
- Effective Documentation: Master documenting and maintaining validated systems.
- Data Governance and Integrity: Unpack the FDA’s 2018 guidance on these key areas.
- Vendor Audit Essentials: Learn how to thoroughly audit vendors in your supply chain.
- Validation Trends: Stay informed about evolving best practices in validation.
- SDLC Best Practices: Discuss top industry practices for the SDLC methodology.
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
- 21 CFR Part 11 Compliance: Understand essential compliance requirements.
- Industry Compliance Best Practices: Explore top standards in system validation.
- Streamlining FDA Compliance: Learn cost-effective, simpler compliance strategies.
- SDLC Methodology: Explain how it bolsters computer system validation.
- Effective Documentation: Master documenting and maintaining validated systems.
- Data Governance and Integrity: Unpack the FDA’s 2018 guidance on these key areas.
- Vendor Audit Essentials: Learn how to thoroughly audit vendors in your supply chain.
- Validation Trends: Stay informed about evolving best practices in validation.
- SDLC Best Practices: Discuss top industry practices for the SDLC methodology.
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
The following benefits from watching this. Even better when done as a group!
- Quality Assurance Manager
- Regulatory Affairs Specialist
- Compliance Officer
- Validation Engineer
- Quality Control Analyst
- IT Manager (in Pharmaceutical or Biotech Industry)
- Data Governance Specialist
- Computer System Validation (CSV) Specialist
- Clinical Data Manager
- Pharmaceutical Quality Systems Manager
- Risk Management Officer
- FDA Regulatory Consultant
- Clinical Research Coordinator
- Pharmacovigilance Associate
- Biotechnology Compliance Analyst
The following benefits from watching this. Even better when done as a group!
- Quality Assurance Manager
- Regulatory Affairs Specialist
- Compliance Officer
- Validation Engineer
- Quality Control Analyst
- IT Manager (in Pharmaceutical or Biotech Industry)
- Data Governance Specialist
- Computer System Validation (CSV) Specialist
- Clinical Data Manager
- Pharmaceutical Quality Systems Manager
- Risk Management Officer
- FDA Regulatory Consultant
- Clinical Research Coordinator
- Pharmacovigilance Associate
- Biotechnology Compliance Analyst
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.
