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 https://www.researchandmarkets.com/r/c004v3
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