Mastering Compliance for FDA-Regulated Systems: Leveraging CSA and GAMP®5 Second Edition
Struggling to Balance Innovation with Compliance in FDA-Regulated Systems?
Instructor :
Carolyn Troiano
Webinar ID:
11893
Date: JAN 08, 2025 (WED)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
Buy This Course in a Pack of 2 courses at 25% Discount HERE:
🌐 Digital & Documentation Compliance Combo (Pack of 2)
“Ensure Compliance Across Digital Systems and Core Documentation Practices”
2 Courses Included:
Why This Pack?
Address the complexities of regulatory compliance for software and device modifications with this strategic pairing. This pack enables professionals to understand regulatory expectations for software changes and align their practices with GAMP®5 guidelines for better software assurance.
Target Audience: Quality Engineers, Validation Specialists, Regulatory Compliance Officers
Why Buy the Pack?
-
- Holistic Approach: Cover both change management for software and comprehensive software assurance.
Buy This Course in a Pack of 2 courses at 25% Discount HERE:
🌐 Digital & Documentation Compliance Combo (Pack of 2)
“Ensure Compliance Across Digital Systems and Core Documentation Practices”
2 Courses Included:
Why This Pack?
Address the complexities of regulatory compliance for software and device modifications with this strategic pairing. This pack enables professionals to understand regulatory expectations for software changes and align their practices with GAMP®5 guidelines for better software assurance.
Target Audience: Quality Engineers, Validation Specialists, Regulatory Compliance Officers
Why Buy the Pack?
-
- Holistic Approach: Cover both change management for software and comprehensive software assurance.
- Enhanced Compliance Confidence: Navigate complex regulatory landscapes for digital systems at a lower price.
- Cost Efficiency: Save on essential training that ensures both accuracy and compliance across digital systems.
Note: Do you want to custom design your pack and choose courses of your choice? Just drop us an email at support@compliancemeet.com or call at Toll Free: +1 (888) 959-4972. We’ll be happy to help you!
Buy Both Courses at a 25% discount HERE
What will you learn
-
- Introduction To GxP Systems And Their Compliance Requirements
- Overview Of GAMP®5 Practices For Enhanced Validation And Compliance
- Effective CSV And SDLC Approaches For FDA-Regulated Systems
- Documenting And Maintaining Validated Systems Across The Life Cycle
- Ensuring Data Integrity And Compliance With 21 CFR Part 11
- Conducting Risk Assessments And ….
-
- Introduction To GxP Systems And Their Compliance Requirements
- Overview Of GAMP®5 Practices For Enhanced Validation And Compliance
- Effective CSV And SDLC Approaches For FDA-Regulated Systems
- Documenting And Maintaining Validated Systems Across The Life Cycle
- Ensuring Data Integrity And Compliance With 21 CFR Part 11
- Conducting Risk Assessments And Evaluating Critical System Characteristics
- Preparing For FDA Inspections, Audits, And Vendor Oversight
Course Description
FDA-regulated industries have adhered to computer system validation for over 30 years, covering systems in manufacturing, testing, and distribution.
These regulations ensure thorough planning, implementation, integration, testing, and management of computer systems that handle crucial data.
Key Highlights:
-
- Introduction to Electronic Records and Signatures (ER/ES) via 21 CFR Part 11, detailing the requirements for validation in FDA-regulated environments.
- Evolution of industry responsibility for risk-based validation of computer systems, including:
- System size and complexity
- Business criticality
- GAMP®5 category
- Risk rating
- Overview of the traditional Computer System Validation (CSV) approach versus Computer Software Assurance (CSA), emphasizing FDA’s flexibility in compliance methods.
- Insights into how GAMP®5 Second Edition aligns with CSA for a streamlined compliance process.
This webinar will delve into FDA’s heightened focus on data integrity during computer system validation, covering systems involved in data creation, collection, analysis, management, and reporting.
Key areas include:
-
- Best industry practices in GAMP®5 Second Edition and their impact on validation processes.
- FDA’s recent draft guidance on CSA and its implications for validation approaches.
- Strategic evaluation of computer systems for data integrity, product quality, and consumer safety, using the System Development Life Cycle (SDLC) approach based on risk assessment.
- Understanding and managing 21 CFR Part 11 for electronic records and signatures.
- Developing essential policies, procedures, and preparing for FDA inspections.
- Vendor auditing for hardware, software, and services to ensure compliance.
- Industry best practices with a focus on data integrity and risk assessment using GAMP®5 and CSA.
By the end of this webinar, attendees will gain a comprehensive understanding of how to effectively leverage GAMP®5 Second Edition and CSA to achieve compliance in FDA-regulated environments.
Enroll Now!
FDA-regulated industries have adhered to computer system validation for over 30 years, covering systems in manufacturing, testing, and distribution.
These regulations ensure thorough planning, implementation, integration, testing, and management of computer systems that handle crucial data.
Key Highlights:
-
- Introduction to Electronic Records and Signatures (ER/ES) via 21 CFR Part 11, detailing the requirements for validation in FDA-regulated environments.
- Evolution of industry responsibility for risk-based validation of computer systems, including:
- System size and complexity
- Business criticality
- GAMP®5 category
- Risk rating
- Overview of the traditional Computer System Validation (CSV) approach versus Computer Software Assurance (CSA), emphasizing FDA’s flexibility in compliance methods.
- Insights into how GAMP®5 Second Edition aligns with CSA for a streamlined compliance process.
This webinar will delve into FDA’s heightened focus on data integrity during computer system validation, covering systems involved in data creation, collection, analysis, management, and reporting.
Key areas include:
-
- Best industry practices in GAMP®5 Second Edition and their impact on validation processes.
- FDA’s recent draft guidance on CSA and its implications for validation approaches.
- Strategic evaluation of computer systems for data integrity, product quality, and consumer safety, using the System Development Life Cycle (SDLC) approach based on risk assessment.
- Understanding and managing 21 CFR Part 11 for electronic records and signatures.
- Developing essential policies, procedures, and preparing for FDA inspections.
- Vendor auditing for hardware, software, and services to ensure compliance.
- Industry best practices with a focus on data integrity and risk assessment using GAMP®5 and CSA.
By the end of this webinar, attendees will gain a comprehensive understanding of how to effectively leverage GAMP®5 Second Edition and CSA to achieve compliance in FDA-regulated environments.
Enroll Now!
Why you should attend
This 90-minute webinar is essential for professionals in FDA-regulated industries—pharmaceuticals, medical devices, biologics, and tobacco products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.)—who are involved in the planning, execution, or support of computer system validation (CSV).
With new FDA guidelines and evolving industry standards, now is the time to update your skills and lead your organization to compliance excellence.
Key Reasons to Attend:
-
- Stay Current with GAMP®5 and CSA
Learn how to adapt your current validation practices to align with GAMP®5 Second Edition (July 2022) and the FDA’s CSA Draft Guidance (September 2022). Stay ahead by adopting cutting-edge compliance standards. - Gain Insights into New Guidelines
Discover how these latest guidelines impact validation processes, especially with innovative technologies that are transforming the landscape. Equip yourself with the insights to navigate this shift effectively. - Modernize Your Approach to Validation
Leave outdated methods behind and learn strategies to leverage modern technological advancements in validation. Enhance both compliance and operational efficiency for your organization. - Achieve Competitive Advantage through Compliance
Staying updated with GAMP®5 and CSA not only ensures compliance but also opens the door to innovative tools that can propel business success. Position your organization as a forward-thinking leader in the industry. - Accelerate Market Readiness of Products
Mastering these new approaches helps bring advanced products to market faster, keeping your company compliant, competitive, and agile in a rapidly changing industry.
- Stay Current with GAMP®5 and CSA
By attending, you’ll gain actionable knowledge to rethink validation practices and harness the latest technologies to achieve compliance. Propel your career and organization toward greater success by mastering these essential FDA compliance strategies.
Join Now and be at the forefront of compliance innovation!
This 90-minute webinar is essential for professionals in FDA-regulated industries—pharmaceuticals, medical devices, biologics, and tobacco products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.)—who are involved in the planning, execution, or support of computer system validation (CSV).
With new FDA guidelines and evolving industry standards, now is the time to update your skills and lead your organization to compliance excellence.
Key Reasons to Attend:
-
- Stay Current with GAMP®5 and CSA
Learn how to adapt your current validation practices to align with GAMP®5 Second Edition (July 2022) and the FDA’s CSA Draft Guidance (September 2022). Stay ahead by adopting cutting-edge compliance standards. - Gain Insights into New Guidelines
Discover how these latest guidelines impact validation processes, especially with innovative technologies that are transforming the landscape. Equip yourself with the insights to navigate this shift effectively. - Modernize Your Approach to Validation
Leave outdated methods behind and learn strategies to leverage modern technological advancements in validation. Enhance both compliance and operational efficiency for your organization. - Achieve Competitive Advantage through Compliance
Staying updated with GAMP®5 and CSA not only ensures compliance but also opens the door to innovative tools that can propel business success. Position your organization as a forward-thinking leader in the industry. - Accelerate Market Readiness of Products
Mastering these new approaches helps bring advanced products to market faster, keeping your company compliant, competitive, and agile in a rapidly changing industry.
- Stay Current with GAMP®5 and CSA
By attending, you’ll gain actionable knowledge to rethink validation practices and harness the latest technologies to achieve compliance. Propel your career and organization toward greater success by mastering these essential FDA compliance strategies.
Join Now and be at the forefront of compliance innovation!
Areas Covered
-
- Introduction to “GxP” Systems: Learn how to identify systems that require Good Practice (GxP) compliance.
- GAMP®5 (Second Edition) Overview: Understand the latest best practices from GAMP®5 and how they impact validation work.
- Computer System Validation (CSV) Approach: Discuss the CSV approach based on FDA requirements and guidelines.
- System Development Life Cycle (SDLC) in Validation: Learn about the SDLC approach and how it applies to validation processes.
- Documenting Validation Efforts: Discover best practices for documenting computer system validation, including requirements, design, development, testing, and operational maintenance procedures.
- Maintaining a Validated System: Understand how to maintain a system in a validated state throughout its entire life cycle.
- Assuring Data Integrity: Learn how to ensure the integrity of data that supports GxP work.
- “GxP” Documentation Compliance: Discuss the importance of documentation that complies with FDA requirements.
- Policies and Procedures for Validation: Learn about the necessary policies and procedures to support validation processes and ongoing system maintenance.
- 21 CFR Part 11 Compliance: Understand the key components for compliance with electronic records and signatures.
- Regulatory Influences and FDA’s Current Thinking: Know the regulatory factors that shape FDA’s approach to computer system validation.
- Conducting Risk Assessments: Learn how to conduct a risk assessment on computer systems to develop a validation rationale.
- Assessing System Characteristics: Understand the need to evaluate system size, complexity, business criticality, GAMP®5 category, and risk of failure for comprehensive validation.
- Preparing for FDA Inspections and Audits: Learn how to best prepare for an FDA inspection or audit of a GxP computer system.
- Vendor Audits for Oversight: Understand the importance of performing thorough vendor audits to ensure oversight of their products and services.
- Industry Best Practices for Validation and Compliance: Learn best practices based on risk assessment to optimize validation and ensure data integrity throughout the data life cycle.
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.
-
- Introduction to “GxP” Systems: Learn how to identify systems that require Good Practice (GxP) compliance.
- GAMP®5 (Second Edition) Overview: Understand the latest best practices from GAMP®5 and how they impact validation work.
- Computer System Validation (CSV) Approach: Discuss the CSV approach based on FDA requirements and guidelines.
- System Development Life Cycle (SDLC) in Validation: Learn about the SDLC approach and how it applies to validation processes.
- Documenting Validation Efforts: Discover best practices for documenting computer system validation, including requirements, design, development, testing, and operational maintenance procedures.
- Maintaining a Validated System: Understand how to maintain a system in a validated state throughout its entire life cycle.
- Assuring Data Integrity: Learn how to ensure the integrity of data that supports GxP work.
- “GxP” Documentation Compliance: Discuss the importance of documentation that complies with FDA requirements.
- Policies and Procedures for Validation: Learn about the necessary policies and procedures to support validation processes and ongoing system maintenance.
- 21 CFR Part 11 Compliance: Understand the key components for compliance with electronic records and signatures.
- Regulatory Influences and FDA’s Current Thinking: Know the regulatory factors that shape FDA’s approach to computer system validation.
- Conducting Risk Assessments: Learn how to conduct a risk assessment on computer systems to develop a validation rationale.
- Assessing System Characteristics: Understand the need to evaluate system size, complexity, business criticality, GAMP®5 category, and risk of failure for comprehensive validation.
- Preparing for FDA Inspections and Audits: Learn how to best prepare for an FDA inspection or audit of a GxP computer system.
- Vendor Audits for Oversight: Understand the importance of performing thorough vendor audits to ensure oversight of their products and services.
- Industry Best Practices for Validation and Compliance: Learn best practices based on risk assessment to optimize validation and ensure data integrity throughout the data life cycle.
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
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Leaders Aiming to Enhance Compliance
- Validation Managers Seeking Best Practices
- IT Professionals Ensuring System Integrity
- Regulatory Affairs Experts Focused on FDA Compliance
- Project Managers Overseeing Validation Projects
- Training Managers Building Competent, Compliance-Savvy Teams
- HR Professionals Developing Compliance-Oriented Learning Plans
- Operations Managers Focused on Efficient Compliance
- Product Managers Bringing Safe, Compliant Products to Market Faster
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Leaders Aiming to Enhance Compliance
- Validation Managers Seeking Best Practices
- IT Professionals Ensuring System Integrity
- Regulatory Affairs Experts Focused on FDA Compliance
- Project Managers Overseeing Validation Projects
- Training Managers Building Competent, Compliance-Savvy Teams
- HR Professionals Developing Compliance-Oriented Learning Plans
- Operations Managers Focused on Efficient Compliance
- Product Managers Bringing Safe, Compliant Products to Market Faster
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.
