Developing a Compliant Drug Validation Plan
Inadequate validation of electronic record keeping is a frequent citation in FDA 483s and warning letters.
This management report will tell you how to develop and implement a drug validation plan that will satisfy FDA and international regulators. It focuses on using ASTM E2500 and ICH Q9 to create risk-based assessments that increase compliance, minimize the spiraling costs of validation and reduce project delivery time. This report also provides a step-by-step approach to the planning, execution and reporting of computer system validation activities.
You will learn:
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