Online Computer System Validation (CSV/CSA) Course: Navigating Changing Landscapes - 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems

DUBLIN, Oct. 27, 2023 /PRNewswire/ — The “Computer System Validation (CSV/CSA), 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems” training has been added to ResearchAndMarkets.com’s offering.

In today’s fast-evolving technological landscape, organizations face the imperative to reevaluate their business models. What were once structured and predictable operations are now characterized by complexity and unpredictability. Patients and customers are more informed and hold higher expectations than ever before. As such, work practices and tools must adapt to meet these evolving challenges head-on.

Join us for an insightful webinar that explores the shifting paradigms of software development, validation, and system maintenance in a continuously changing environment. This session will offer a comprehensive comparison of agile and waterfall methodologies, highlighting their respective advantages and disadvantages. Recognizing that a one-size-fits-all approach may not be suitable, this webinar will guide you in making informed decisions when choosing the right methodology.

Additionally, we will delve into the world of Commercial Off-The-Shelf (COTS) solutions, Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), and cloud services, uncovering the benefits and risks associated with each model. Throughout the discussion on hardware and software options, we will emphasize best practices for aligning with FDA requirements for validation, including compliance with 21 CFR Part 11 and data integrity standards.

This session will also shed light on the FDA’s current areas of concern and how to ensure that your systems meet their expectations.

Key Takeaways:

Learn how to leverage modern technology while remaining compliant with FDA regulations for computer systems and data.
Explore the modernization of the System Development Life Cycle (SDLC) with an agile approach, in alignment with FDA’s draft guidance for Computer Software Assurance (CSA).
Understand the pros and cons of different validation approaches and industry best practices for success.
Gain insights into validating systems to meet 21 CFR Part 11 and data integrity compliance.
Navigate the complexities of compliance with data privacy laws, including HIPAA, GDPR, and other privacy regulations.
Get an overview of spreadsheet validation and streamline the validation process for commonly used tools like MS Excel and Google Sheets.

Areas Covered

Learn how to identify “GxP” Systems
Learn about FDA’s current thinking about technology and software development, and how this will impact industry
Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements
Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
Learn about cloud services and cloud service providers to optimize your experience
Learn ways to validate in the cloud without compromising quality or compliance
Learn the pros and cons of an agile vs. waterfall approach
We will discuss cloud computing and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), and Platform-as-a-Service (PaaS) systems that can be embraced and validated effectively
Discuss the best practices for documenting computer system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness of managing related documentation
Understand the best approach to Installation Qualification (IQ) testing when the system components are not on premise, but are in the cloud
Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner, applying an agile continuous validation approach
Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
Discuss the importance of “GxP” documentation that complies with FDA requirements
Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
Know the regulatory influences that lead to FDA’s current thinking at any given time
Learn about current trends in FDA compliance and enforcement
Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
Q&A

Who Should Attend:

Personnel in the following roles will benefit:

Information Technology Analysts
Information Technology Developers and Testers
Software Quality Assurance Professionals
QC/QA Managers and Analysts
Analytical Chemists
Compliance and Audit Managers
Laboratory Managers
Automation Analysts
Manufacturing Specialists and Managers
Supply Chain Specialists and Managers
Regulatory Affairs Specialists
Regulatory Submissions Specialists
Risk Management Professionals
Clinical Data Analysts
Clinical Data Managers
Clinical Trial Sponsors
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders/Subject Matter Experts
Business System/Application Testers
Vendors responsible for software development, testing and maintenance
Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Key Topics Covered:

Module 1: CSV Methods and Models

GxP Systems
Computer System Validation (CSV)
Common SDLC Methodologies
GAMP5 “V” Model
Computer System Validation (CSV) vs. Computer Software Assurance (CSA)
Critical Thinking
Waterfall vs. Agile Methodology

Module 2: Software and Services

Computer Off-the-Shelf (COTS) Software
Cloud Systems
Software as a Service (SaaS)
Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
Single Sign On (SSO)
Medical Devices using Software.
Software-as-a-Medical Device (SaaMD)
Mobile Devices
Spreadsheet Validation

Module 3: CSV Planning

Validation Plan
Rationale for Validation Testing
GAMP5 System Categorization
Risk Assessment and Mitigation

Module 4: System Requirements and Design

Requirements Development
User Requirements Specification (URS)
Functional Requirements Specification (FRS)
System Design/Configuration Management Specification (SDS/CMS)

Module 5: IQ, OQ, PQ Test Planning & Execution

Validation Protocols – IQ, OQ, PQ
Validation Test Execution
Validation Test Summary Report

Module 6: Test and Validation Reports

Requirements Traceability Matrix (RTM)
Validation Summary Report
System Acceptance and Release Notification

Day 1 Q&A Session

Day 2:

Module 7: CSV Operations and Maintenance

Maintaining a System in a Validated State
Disaster Recovery Planning
Business Continuity Planning
Incident Reporting, Investigation, and Remediation
Record Retention
System Retirement Challenges
Legacy Systems and Integration
Spreadsheet Validation

Module 8: CSV Supporting Components

Good Documentation Practices (GDPs)
Training
Organizational Change Management (OCM)
Validation Policies and Procedures

Module 9: Managing FDA-Regulated Data

21 CFR Part 11 Guidance
Electronic Records/Signatures (ER/ES) Requirements
Data Integrity: ALCOA+ Principles
Data Life Cycle Approach
Data Governance
Data Privacy: HIPAA, GDPRs, et al

Module 10: Vendor Audit

Audit Preparation
Audit Execution
Post-Audit
Vendor Contracts and Service Level Agreements (SLAs)

Module 11: FDA Trends

Regulatory Influences
Regulatory Trends
Current Compliance and Enforcement Trends

Module 12: Inspection Preparation

FDA Inspection Readiness
Industry Best Practices

Day 2 Q&A Session

Module 13: CSV Exercises

Exercise 1: CSV
Exercise 2: Validation Plan (VMP) Writing
Exercise 3: Risk Assessment
Exercise 4: FDA Requirements for ER/ES
Exercise 5: Interviews and URS/FRS Writing
Exercise 6: IQ, OQ, PQ Test Protocol Writing
Exercise 7: RTM Writing
Exercise 8: Be the Consultant

Speakers:

Carolyn Troiano

Webinar/Seminar/Workshop Instructor in FDA Compliance Training

Carolyn Troiano has more than 35 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

For more information about this training visit https://www.researchandmarkets.com/r/imrd9w

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Media Contact:

Research and Markets

Laura Wood, Senior Manager

[email protected]

For E.S.T Office Hours Call +1-917-300-0470

For U.S./CAN Toll Free Call +1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907

Fax (outside U.S.): +353-1-481-1716