★You can take the course starting from the level of "What is CSV?!" ★You will be able to understand the content of the "Computer System Appropriate Management Guidelines"!
Lecturer Mr. Hiroyuki Asada, Chief Engineer, Pharmaceutical and Food Systems Department, Total Solutions Division, Hitachi, Ltd. Target Audience: Those who want to learn about CSV from the basics or wish to review. Venue: Kawasaki City Educational and Cultural Center, Room 1【Kanagawa, Kawasaki Station】13 minutes on foot from JR and Keikyu Kawasaki Station. Please note that the venue may change to a location in the Tokyo metropolitan area due to scheduled power outages. We will notify you one week prior to the event date. Thank you for your understanding. Date and Time: June 27, 2011 (Monday) 13:00-16:30 Capacity: 20 people *Please apply early as there may be a rush of applications. Participation Fee: 49,350 yen (tax included, including text costs) for up to 2 people from one company. *New members applying for the first time by June 13 will receive an early bird discount price of 44,100 yen. ◆ Early Bird Discount: Please select "1 slot for 2 people: Early Bird Discount" when registering. ◆ For additional applications from the same organization, an additional 12,600 yen will be charged per person.
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basic information
I hope you will acquire a basic understanding of CSV.
Price range
P2
Delivery Time
P2
Applications/Examples of results
1. Basics of CSV 2. Validation Plan 3. Creation of User Requirements Specification (URS) 4. Review of Functional Specification (FS) - What is FS? - What to check during the review? 5. System Construction from Design Specification (DS) 6. Installation Qualification (IQ) 7. Operational Qualification (OQ) 8. Performance Qualification (PQ) 9. Traceability 10. Validation Report - What to report? - Go sign for operation - How to summarize issues and deviations 11. What to do in such cases? - A system introduced 5 years ago: No URS! What to do? - This becomes FS - How far to go during system updates? 12. Deepening Understanding - Why is CSV necessary? (Regulatory basis) - [FDA] Pitfalls of CSV - [Domestic] What is included in the "Guidelines for the Proper Management of Computer Systems"? - [FDA] 21 CFR Part 11 and CSV, latest trends in FDA Part 11 inspections - [Domestic] Ministry of Health, Labour and Welfare ER/ES Guidelines and CSV - What has changed with GAMP5
Company information
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