NEW! FDA Compliance Seminar:
Computer Systems Validation for the Pharmaceutical Industry

2-Day Seminar:
Crs#00.628-041
Two Days; Meets 9am-4pm; Thursday/Friday, June 12, 13
Held on Lowell Campus; Tuition: $725; CEUs: 1.4

Overview
This basic course introduces participants to regulatory requirements for computer systems in the pharmaceutical industry by presenting a logical and effective structure for achieving the validation of computerized systems. It will lay out the basic validation methodology from the Validation Master Plan, requirements documentation and testing protocols (IQ, OQ and PQ), and will cover validation methodology which is a vehicle for documenting the fit for intended use. It will also meet current regulations by building upon existing industry good practice in an efficient and effective manner. Participants are given an overview of the computer systems compliance life cycle and they will learn the FDA’s approach on Risk management and how to logically and pragmatically apply the FDA’s new line of thinking with industry practice. Participants of this course will walk away with a good understanding of the validation life cycle and how to implement testing for computer systems. The participants will also leave with an understanding of the risk based approach and how it can be applied to their current jobs.

Content
Introduction:

• FDA
• Code of Federal Regulations (21 CFR part 11, 210, 211 and 820)
• FDA warning letters

Computer Validation life cycle and documentation:

• Draft guidance documents
• Planning (Validation and Quality plan)
• Leveraging methodologies
• Requirements (User, Functional and Design requirements)
• Testing documents (Installation Qualification, Operational Qualification and Performance Qualification)
• Summary Reports

Commonalities in Risk Base philosophies:

• ICH Q9
• FMEA
• FTA
• HAZOP
• HACCP

Risk based workshop:

• Using real world examples

Instructor
Kosal Keo is a Department Manager for an IT Validation/Compliance group and he has over 10 years of industry experience working for some of the pharmaceutical industry’s largest firms. He has done private consulting in the area of computer systems validation, quality systems control, and risk assessment.

For more information or to register, please contact Karen von Sneidern at (978) 934-2473 or email Karen_vonsneidern@uml.edu

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