2 Day FDA Pharma & Biotech Computerized Systems Validation, Data Integrity & Cloud Computing Webinar: Explore Compliance Strategies For COTS And Cloud Software (ONLINE EVENT: July 2-3, 2025)

(MENAFN- GlobeNewsWire - Nasdaq) Join our comprehensive webinar on agile vs. waterfall methodologies for system validation, including FDA compliance insights! Discover strategies to modernize your System Development Life Cycle and ensure data integrity with CSA, GAMP®5, SDLC, COTS, SaaS, IaaS, and PaaS insights. Register now!

Dublin, June 25, 2025 (GLOBE NEWSWIRE) -- The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech" has been added to ResearchAndMarkets.com's offering.

The seminar will take an in-depth look at commercial software options like COTS, SaaS, IaaS, PaaS, and other cloud services. It will examine the benefits and risks of these models while detailing best practices for compliance with FDA validation requirements, including 21 CFR Part 11 and data integrity. Attendees will get insights into the FDA's current stance on technology and compliance expectations.

As technology continues to advance, organizations are transforming to meet increasingly informed and demanding customer needs. To maintain a competitive edge, work practices and tools require adaptation. This seminar will explore methods for developing software, validating performance, and maintaining alignment with evolving business models. Highlighting both agile and waterfall methodologies, the session will compare their advantages and limitations in maintaining validated systems throughout their lifecycle.

Learn how to leverage cutting-edge technology for FDA compliance, focusing on modernizing the System Development Life Cycle (SDLC) via a risk-based CSA approach using agile methodologies. This includes utilizing automated testing tools to enable continuous software validation. The approach aligns with GAMP5, Second Edition methodologies, ensuring compliance and operational success. Participants will also gain insights into data privacy regulations like HIPAA and GDPRs.

Additionally, the discussion will cover best practices for COTS software, SaaS, and other cloud services, guiding attendees in making informed decisions on contracts and Service Level Agreements (SLAs) to suit organizational needs. Spreadsheet validation will also be addressed, equipping participants with efficient strategies to manage customizations and ensure compliant data handling.

This immersive in-person seminar promises interactive discussions that encourage attendees to bring forth their most pressing challenges and pain points related to validation, fostering problem-solving sessions.

Key Topics Include:

• Identifying and applying FDA regulations on GxP systems
• Updating CSV approaches for compliance with FDA requirements
• Modernizing SDLC with agile approaches and automated testing
• Optimizing cloud services and validating without quality compromise
• Documenting validation efforts for both agile and waterfall methodologies
• Maintaining data integrity through an agile validation approach
• Understanding new trends in FDA compliance

12.0 RAC CREDITS

RAPS - Eligible for up to 12 credits for RAC recertification upon full completion.

Webinar Benefits for Attendees:

• 2-Day CSV Training Session
• Downloadable presentation slides
• Certificate of participation
• Q&A Session
• Free handouts on CSV

Who Should Attend:

• 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

Key Topics Covered:

Day 1:

Module 1: CSV Methods and Models

Module 2: Software and Services

Module 3: CSV Planning

Module 4: System Requirements and Design

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

Module 6: Test and Validation Reports

Day 1 Q&A Session

Day 2:

Module 7: CSV Operations and Maintenance

Module 8: CSV Supporting Components

Module 9: Managing FDA-Regulated Data

Module 10: Vendor Audit

Module 11: FDA Trends

Module 12: Inspection Preparation

Day 2 Q&A Session

Module 13: CSV Exercises

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

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