Points on planning and implementing experimental design for analytical method validation, and considerations for the procedure.
S00562
Points on planning and implementing experimental design for analytical method validation and examination procedures.
1. Purpose of Analytical Method Validation 2. Experimental Design for Analytical Method Validation 3. Implementation Methods for Analytical Method Validation 4. Key Points for Examining Linearity 5. Key Points for Examining DL/QL 6. Key Points for Examining Accuracy 7. Methods and Evaluation of Precision Calculation 8. General Precautions 9. Comparison of Old and New Quantitative Methods for AAA Preparations 10. Points to Note in Stability Testing 11. System Suitability in HPLC Methods 12. Considerations for Setting Standards 13. Quality Standards for Investigational Drugs 14. Technology Transfer 15. Outsourcing to External Testing Organizations 16. Quality System (ICH Q10) and Quality Risk Management (ICH Q9) 17. Risk Management & Compliance [Q&A and Business Card Exchange] *Requests for content in advance are also welcome!*
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The instructor will explain in an easy-to-understand manner for practical staff the points of analytical method validation that serve as the basis for the "validity verification data of standards and testing methods" required for CTD applications, as well as the necessary responses to anomalies and deviations in laboratory management, incorporating the perspectives of inspection or regulatory authorities. For first-time applicants, the fee is 37,000 yen (including tax, text costs, and tea expenses) per person ⇒ Registration required (free membership registration). A new member recruitment campaign is currently underway (until April 23, with a guaranteed discount point of 5,000 yen). A separate lunch fee of 1,050 yen will be charged. *If two people from the same organization apply, the total fee is 69,300 yen.
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Speaker: Masao Ito, Deputy Director, CMC Development QA Department, Chugai Pharmaceutical Co., Ltd. Target Audience: Personnel responsible for CMC or regulatory affairs in quality and research and development departments, as well as representatives from contract testing organizations. Venue: Kawasaki City Education and Culture Hall, 4th Floor, Room 2 [Kanagawa, Kawasaki] Date and Time: May 28, 2010 (Friday) 10:30 AM - 4:00 PM For more details and registration, please check the URL: http://ec.techzone.jp/products/detail.php?product_id=572
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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.