DUBLIN–(BUSINESS WIRE)–ResearchAndMarkets.com has announced the addition of a new online course titled "Risk-based Computer System Validation: Reduce Costs and Avoid 483s" to its offerings. The course is scheduled for August 6-7, 2025, and aims to provide practical insights and proven techniques to reduce the costs associated with implementing and maintaining computer systems in regulated environments by up to two-thirds. Course Overview This highly interactive two-day course utilizes real-world examples to guide participants through the complexities of computer system validation. It covers essential topics such as the requirements for 21 CFR Part 11 and Annex 11, including standard operating procedures (SOPs), software product features, infrastructure qualification, and validation documentation. The instructor also delves into the latest industry standards for data security, data transfer, audit trails, electronic records, and signatures. Key Highlights Compliance Requirements: Detailed exploration of the specific requirements for local and Software as a Service (SaaS)/cloud hosting solutions. Cost Reduction: A 10-step risk-based approach to computer system validation that helps decrease software implementation times and lower costs. Industry Trends: Review of recent FDA inspection trends and methods to streamline document authoring, revision, review, and approval. Data Privacy: Guidance on writing a Data Privacy Statement to comply with the EU General Data Protection Regulation (GDPR). Professional Development: Ideal for professionals in healthcare, clinical trials, biopharmaceuticals, and medical devices, as well as software vendors, auditors, and quality staff involved in GxP applications. Learning Objectives By the end of the course, participants will: - Understand the requirements of 21 CFR Part 11 and Annex 11. - Know how to comply with regulations and avoid 483 and Warning Letters. - Be familiar with the four primary areas of Part 11 compliance: SOPs, software product features, infrastructure qualification, and validation documentation. - Grasp the implications of SaaS and cloud computing on qualification and validation. - Ensure data integrity, security, and protection of intellectual property. - Recognize the current industry standards for security, data transfer, and audit trails. - Understand the use of electronic signatures, digital pens, and biometric signatures. - Identify necessary SOPs for the IT infrastructure. - Know which product features to consider when purchasing Commercial Off-The-Shelf (COTS) software. - Utilize easy-to-understand fill-in-the-blank validation documents to minimize resource requirements. Who Should Attend This course is beneficial for anyone who uses computer systems in their job, particularly those working in: - Healthcare - Clinical trials - Biopharmaceuticals - Medical devices - Software vendors - Auditors - Quality staff involved in GxP applications Course Agenda Day 1 - Introduction to the FDA (1.5 hours): Gain a foundational understanding of FDA regulations. - 21 CFR Part 11/Annex 11 Compliance (3.5 hours): - Interpret the implications of Part 11 beyond the regulations. - Avoid 483 and Warning Letters. - Explore the four primary areas of Part 11 compliance. - Understand how SaaS and cloud computing affect qualification and validation. - Ensure data integrity, security, and protection of intellectual property. - Learn current standards for data security, transfer, and audit trails. - Discuss electronic signatures, digital pens, and biometric signatures. - Identify necessary SOPs for IT infrastructure. - Consider product features when purchasing COTS software. - Reduce validation resources with user-friendly documents. The Five Keys to COTS Computer System Validation (30 minutes): Key principles to simplify COTS software validation. - The Validation Team (30 minutes): Roles and responsibilities within the validation team. - Ten-Step Process for COTS Risk-Based Computer System Validation (30 minutes): Begin the discussion on the structured risk-based validation approach, continued on Day 2. Day 2 - Continuation of the Ten-Step Process for COTS Risk-Based Computer System Validation (2.5 hours): Complete the ten-step method and explore advanced techniques. - Streamline Document Management (2 hours): - Streamline document authoring, revision, review, and approval processes. - Apply efficient strategies to manage validation documentation. - Data Privacy Compliance (1 hour): Write a Data Privacy Statement to meet GDPR requirements. For more information about this course, visit https://www.researchandmarkets.com/r/d75gk1. About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading provider of international market research reports and market data. They offer the latest insights on international and regional markets, key industries, leading companies, new products, and prevailing trends.