Computer System Validation - Reduce Costs and Avoid 483s (com) A
Computer System Validation - Reduce Costs and Avoid 483s *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***REGISTER TODAY! This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing. These vendors are not regulated, and therefore, regulated companies must ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters. This Computer System Validation Training course is intended for these regulated companies, software vendors, and SaaS/cloud providers. The seminar instructor will: Address the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Help participants understand the specific requirements associated with local and SaaS/cloud hosting solutions. Illustrate the importance of validating the quality process and every computerized system used in laboratory, clinical, and manufacturing settings. Demonstrate how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation. Review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval. Seminar Fee Includes:LunchAM-PM Tea/CoffeeSeminar MaterialUSB with seminar presentationHard copy of presentationAttendance Certificate$100 Gift Cert for next seminar Learning Objective: Understand what is expected in Part 11 and Annex 11 inspections Avoid 483s and Warning Letters Learn how to buy COTS software and qualify vendors Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds Requirements for local, SaaS, and cloud hosting How to select resources and manage validation projects "Right size" change control methods that allows quick and safe system evolution Minimize the validation documentation to reduce costs without increasing regulatory or business risk Write test cases that trace to elements of risk management Protect intellectual property and keep electronic records safe Who will Benefit: This CSV Training Course will benefit all who use computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications. Regulatory Affairs QA/ QC IT/IS Software Managers Project Managers Software vendors and suppliers AGENDA Day 01(8:00 AM - 5:00 PM) 08.00 AM - 08.30 AM: Registration 08.30 AM: Session Start Introduction to the FDA (1 hr) How the regulations help your company to be successful Which data and systems are subject to Part 11. 21 CFR Part 11 - Compliance for Electronic Records and Signatures (4 hr) What Part 11 means to you, not just what it says in the regulation. Avoid 483 and Warning Letters. Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation. How SaaS/cloud computing changes qualification and validation Ensure data integrity, security, and protect intellectual property. Understand the current computer system industry standards for security, data transfer, and audit trails. Electronic signatures, digital pens, and biometric signatures. SOPs required for the IT infrastructure. Product features to look for when purchasing COTS software. Reduce validation
San Diego, California, United States
San Diego, CA
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