See How Information Technology is Used in Regulated Industries
Research and Markets ( http://www.researchandmarkets.com/reports/c27518 ) has announced the addition of E-Learning Course: IT Use and Analytical Validation (Certified) to their offering.
A modern analytical laboratory faces a variety of regulatory and operational challenges including:
— Operating in compliance with GMP and other applicable industry regulations
— Optimizing use of available resources
— Consistently generating reliable and trustworthy data
— Minimizing errors, levels of retesting and waste
These challenges cannot be successfully met without the input of a competent, well-trained laboratory workforce.
“IT Use and Analytical Validation” forms part of the EssentialAnalyst(TM) e-Learning curriculum which is specially designed for analysts in regulated industries such as Finished Dose Pharmaceuticals, API/Bulk chemical manufacturing, Biotechnology and Medical Devices. It provides critical knowledge in key areas such as current Good Manufacturing Practice (CGMP), laboratory practices, techniques, and health and safety issues.
Accessed via the Internet or your company’s intranet, each EssentialAnalyst(TM) course is a multimedia learning experience that combines text, graphics, animation and audio to present critical knowledge in an engaging and interactive way.
Equipped with such knowledge, the transition from trainee to competent analyst is made smoother and more efficient. Standard Operating Procedures (SOPs), with their own particular industry jargon, become easier to understand. On-the-Job Training becomes more effective as trainees comprehend what they see and hear.
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
For more information visit http://www.researchandmarkets.com/reports/c27518
