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E-Learning Course: IT Use and Analytical Validation (Certified)
CompuPharma Ltd
This course begins by explaining the basics of Information Technology and Good Computer Practice and describes how information technology is used in regulated industries.
The fundamentals of computerized systems validation are explained and how the validation process works.
This is followed by a detailed examination of 21 CFR Part 11 and its impact on regulated industries. There is particular emphasis on electronic records and signatures (ERES).
The course continues with an examination of analytical method validation. Analytical method validation is essential in demonstrating that a particular method is suitable for its intended use. It is a concept that all competent analysts must be able to grasp.
Areas covered include standards, LOD, LOQ, precision and accuracy. System suitability checks are explained and why they must be run prior to analysis. The steps involved in laboratory equipment qualification (DQ, IQ, OQ and PQ) are presented and explained.
Topics Covered:
- IT Use in Regulated Industries
- Computerized Systems Validation
- Introduction to 21 CFR Part 11
- Method Validation Parameters
- System Suitability Parameters (HPLC)
- Laboratory Equipment Qualification
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