Understanding the Regulation 21 CFR Part 11 Training - Industrial Technology Systems Ltd

Course Title:	Understanding the Regulation 21 CFR Part 11 Training
Course Duration:	1 day
Course Aims:	This course seeks to provide an understanding of the regulation, 21 CFR Part 11 and provides an update from the latest published guidance.
Course Content:	Understand what the regulation 21 CFR Part 11 is What the requirements are Why have the regulation? Identify key terminology used in the regulation Terms and definitions Lifecycle of a document Electronic Hard copy Records What is in and out of scope? Premises and equipment Links to validation Validation requirements for computer systems Training Requirements Qualifications and experience Management of systems For open and closed systems Physical and logical controls Signatures Signature/record linking Their uniqueness Biometrics Controls Password ageing Procedures Management responsibilities Understand FDA Part 11 Guidance for industry Latest thinking and guidance Describe the GAMP® approach to 21 CFR Part 11 compliance Links with GAMP® and risk assessment Use GAMP® risk assessment to assess a potential real scenario Recall problems encountered by companies applying the rule Potential problem areas Case studies Differing scenarios/FDA warning letter reviews ISPE owns the GAMP® trademark http://www.ispe.org/
Course Dates:	Understanding the Regulation 21 CFR Part 11 Training, 28th February 2008, Cheshire, £380+VAT per learner (£446.50 inc. VAT). Understanding the Regulation 21 CFR Part 11 Training, 17th July 2008, Cheshire, £380+VAT per learner (£446.50 inc. VAT). Understanding the Regulation 21 CFR Part 11 Training, 25th September 2008, London, £399+VAT per learner (£468.83 inc. VAT). Understanding the Regulation 21 CFR Part 11 Training, 13th November 2008, Edinburgh, £380+VAT per learner (£446.50 inc. VAT). GROUP BOOKING DISCOUNT - Book two place on an open course and receive the third place at half price. Cost includes tuition, lunch and training materials. Download a printable version of the Booking Form and Terms and Conditions.
On-site Courses:	This course can be delivered to a group of up to 12 delegates at your premises. Request a quote for an onsite course.
Further Details:	Request more information on this training course.
Related Courses:	GAMP® 4 (3 Day) Training GAMP® 4 Training Understanding Validation Training
Course Calendar:	View Course Calendar

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