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

2. 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. OBJECTIVE : 21CFR Pat 11 | Objective | Audience |Course Outline | Details

3. 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. AUDIENCE : 21CFR Pat 11 | Objective | Audience | Course Outline | Details

4. 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 systems various 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. COURSE OUTLINE: 21CFR Pat 11| Objective | Audience | Course Outline | Details

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