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Comprehensive 21 CFR Part 11 Compliance Training Course

This training course covers the concepts of 21 CFR Part 11 compliance, product features, and validation processes in three primary areas. Participants will learn about risk-based validation approaches and how to prevent FDA violations. The course is designed for system integrators, plant operators, administrators, engineers, and individuals involved in process design and implementation. Topics include regulations, validation life cycle, risk assessment, and FDA inspection preparation. Register at Smart Logic’s offices or visit their website for directions.

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Comprehensive 21 CFR Part 11 Compliance Training Course

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  1. 21CFR Pat 11 | Objective | Audience |Course Outline | Details 21 CFR Part 11 course syllabus / Ilan Shaya 15-16/7/2013

  2. 21CFR Pat 11 | Objective| Audience |Course Outline | Details OBJECTIVE: • Upon completion of this course, students will be able to: • This Training course allows what is required to be 21 CFR Part 11 compliant. It • Concepts of Part 11 and expands them into specific things to do in all three primary areas: SOPs, product features, and validation • Detailed description of Product features based on the current industry standards. • The 10-step risk-based validation approach. • Understand how to eliminate 483s and Warning Letters.

  3. 21CFR Pat 11 | Objective | Audience | Course Outline | Details • AUDIENCE: System integrators. plant floor operators and managers. system administrators. Control automation engineers. Process engineers and other individuals who need to use designing and implementing S88 in their process.

  4. 21CFR Pat 11| Objective | Audience |Course Outline | Details COURSE OUTLINE: • Regulations and Guidelines for Computer System Validation:examine the current GAMP version applied to validating PLC, software and control systems. Both FDA and EU regulatory guidelines will be discussed. • The Computer Validation Life Cycle:The life cycle from design, through construction, installation and live start up for a typical software project. contents of key documents / activities such as URS, FDS, VMP, IQ, OQ, PQ • Risk assessment of Computerized systemsvarious techniques and how to effectively implement to ensure critical risks are identified and correct level of • validation is carried out. • Understanding and Preparing for FDA's Inspection.

  5. 21CFR Pat 11| Objective | Audience |Course Outline | Details For Details and Registration: Smart Logic’s offices: Sun – Thu: 8:00 – 17:00 08-910-20-70 Click here for directions

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