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21 CFR Part 11 Compliance for SaaS/Cloud Applications (com) A

Wednesday, March 27, 2019, 3:00 PM


21 CFR Part 11 Compliance for SaaS/Cloud Applications *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***REGISTER TODAY! This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Understand the specific requirements associated with local and SaaS/cloud hosting solutions. It details the requirements for HIPAA Protect Health Information (PHI) Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation. The instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval. Participants will learn how to write a Data Privacy Statement to comply with the EU General Data Protection Regulation (GDPR). This course benefits anyone that uses computer systems to perform their job functions and is ideal for 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. Seminar Fee Includes:LunchAM-PM Tea/CoffeeSeminar MaterialUSB with seminar presentationHard copy of presentationAttendance Certificate$100 Gift Cert for next seminar  Learning Objectives: Reduce costs, usually by two-thirds, for compliance with electronic records Learn how to use electronic records and electronic signatures to maximize productivity Understand what is expected in Part 11 and Annex 11 inspections so you are prepared Avoid 483 and Warning Letters Understand the responsibilities and specific duties of your staff including IT and QA Understand your responsibilities and liabilities when using SaaS/cloud Learn how HIPAA expands Part 11 compliance Learn how to perform risk-based Computer System Validation using fill-in-the-blank templates How to select resources and manage validation projects "Right size" change control methods that allows quick and safe system evolution Minimize validation documentation to reduce costs without increasing regulatory or business risk Learn how to reduce testing time and write test cases that trace to elements of risk management Learn how to comply with the requirements for data privacy Learn how to buy COTS software and qualify vendors Protect intellectual property and keep electronic records safe  Who will Benefit: GMP, GCP, GLP, regulatory professionals QA/QC IT Auditors Managers and directors Software vendors, hosting providers 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 (1.5 hrs) 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 hrs) What Part 11 means to you, not just what it says in the regulations Avoid 483 and Warning Letters Explore the four primary areas of Part 11 compliance: SOPs, software product features, infrastructure qualification, 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

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