★A clear explanation of Convalley from the very basics! ★Differences between GAMP4 and GAMP5, guidelines for the proper management of computer systems.
【Speaker】 Mr. Kimihide Yokouchi, Chief Engineer, Pharmaceutical and Food Systems Department, Industrial and Distribution Systems Division, Hitachi, Ltd. 【Venue】 Industrial Promotion Hall, Conference Room 1 [Kanagawa, Kawasaki Station] 【Date and Time】 December 6, 2010 (Monday) 13:30-17:30 For those considering checking details or applying, please use the URL below ▼ http://ec.techzone.jp/products/detail.php?product_id=1242
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basic information
【Lecture Summary】 "I was suddenly appointed as the leader of the ●● system implementation project." "I was ordered to carry out the CSV of the ●● system that was handed over from my predecessor." This is a highly regarded CSV crash course seminar that clearly explains the industry-standard GAMP, focusing on understanding and the ability to apply knowledge for those in such situations.
Price information
45150
Price range
P2
Delivery Time
P2
※Expected delivery of the enrollment ticket.
Applications/Examples of results
1. Basics of Computer System Validation (CSV) - What is Computer System Validation (CSV)? - Custom vs. Commercial Off-The-Shelf (COTS) - Tasks that must be done in-house - Tasks that can be outsourced to vendors 2. Validation Plan - Minimum considerations - Too much is as bad as too little 3. Creation of User Requirements Specification (URS) - What to write? - Why is it necessary to write? 4. Review of Functional Specification (FS) - What is FS? - What to check during the review? 5. System Construction from Design Specification (DS) - Custom vs. Commercial Off-The-Shelf (COTS) 6. Installation Qualification (IQ) - What is done in IQ? - Another role of IQ - Overdoing it can haunt future generations 7. Operational Qualification (OQ) 8. Performance Qualification (PQ) 9. Traceability 10. Validation Report 11. What to do in such cases? 12. Deepening Understanding - Why is CSV necessary? (Regulatory basis) - [FDA] Pitfalls of CSV - [Domestic] What is included in the "Guidelines for Proper Management of Computer Systems"? [Q&A and Business Card Exchange]
Company information
Our company has developed its business from "seminar planning" to various forms such as "lecturer dispatch," "publishing planning," "technical consultant dispatch," "trend research," "business matching," and "business development consulting," in order to support clients in a wide range of fields including chemistry, electronics, automotive, energy, medical devices, food, and building materials. By doing so, we have advanced our company and opened up new markets. AndTech promises to continue listening to our clients' voices, entering the business areas and markets they desire, and to remain a company that is loved by our clients, as we share their challenges, think together, and forge new paths.