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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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January 03, 2008 |
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The Center for Professional Innovation & Education, Dublin, Ireland
05/22/08
Who Should Attend
This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with FDA regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.
Learning Objectives
The course is designed to provide a thorough understanding of computer system validation. In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process. The attendee will be familiar with expected content for computer validation deliverables through examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.
Course Description
This course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized.
Topics to be discussed include: Computer Systems Validation (CSV) Process and Deliverables; Auditing GXP Computer Systems; Introduction to 21 CFR Part 11, FDA Requirements for Electronic Records and Electronic Signatures; Final Part 11 Guidance, Scope and Application; Standardized Approach to Part 11 Gap-Analysis and Remediation; Interactive Discussion and Q&A Sessions.
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Organized by:
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Center for Professional Innovation & Education |
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Invited Speakers:
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Please contact The Center for Professional Innovation & Education at info@cfpie.com or call
+1-610-688-1708 for Speaker information.
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Deadline for Abstracts:
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n/a
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Registration:
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To Register, please visit www.cfpie.com or call +1-610-688-1708
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E-mail:
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info@cfpie.com
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