Simplifying Global Compliance
Developing a Compliant Drug Validation Plan
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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:
Why ASTM E2500 and ICH Q9 are superior;
Why “qualification” is a more accurate term than validation;
How to execute a risk assessment and use it for engineering, maintenance and change control decisions;
How to perform testing in different environments;
Tips for writing test scripts;
5 advantages to executing test scripts electronically;
How to use GAMP 5 to determine a system’s software category;
Prerequisites for testing such as available documents, definition of components and data for testing different scenarios;
How to execute screen captures to facilitate third-party reviews;
Step-by-step approaches to documenting and resolving nonconformances; and
Establishing traceability as proof of system functionality.
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Table of Contents
- Process Validation
- Process Design
- Process Qualification
- And More …
View the entire TOC
Who Will Benefit
- Executive management
- Manufacturing directors and supervisors
- Production teams
- Validation officers
- Pharmaceutical and cGMP auditors
- QA/QC personnel
- Compliance officers
- Data management and statistics personnel
- Engineering and design controls teams
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