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Pack of Four: Best Selling Lab Related Webinars
Clinical Labs are a tough environment to be in. Not only are there a multitude of rules, there are a number of areas which are not very clearly defined. On top of all this, the rules keep changing all the time.
ComplianceOnline brings you a special clinical training primer. A package of 4 of our best selling Lab related webinars- available at a 50% discount. Clinical Labs are a tough environment to be in. Not only are there a multitude of rules, there are a number of areas which are not very clearly defined. On top of all this, the rules keep changing all the time.This pack of 4 of our best selling lab related webinars contains 5 hours of training covering some of the most important compliance challenges being faced by Clinical and Analytical Labs today.
Area Covered:
- FDA and International GLP regulations: 21 CFR Part 58.
- Objectives and concepts of GLP’s.
- Special organizational requirements.
- Responsibilities: Management, Study director, QA, analysts.
Area Covered:
- FDA and EU requirements for analytical instrument qualification.
- Most common inspection problems.
- Terminology, scope and principles of the new USP chapter.
- AIQ and its relation to method validation, system suitability testing and quality control checks.
Area Covered:
- FDA and other agency?s requirements for spreadsheet validation - what do inspectors ask and what documents should be available.
- How to design spreadsheets for Part 11/GxP/SOX/HIPAA compliance.
- Validation during design, development, installation and on-going use.
- When, what, and how much to test?
Module4:Transfer of Analytical Methods and Procedures:FDA Requirements and Strategies and Tools for Implementation
Area Covered:
- FDA and International regulations for method transfer.
- Examples of FDA warning letters and how to avoid them.
- The new FDA Guidance on method transfer.
Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Computer System Validation", "Network Quality Package" , and "Validation of Computerized Analytical and Networked Systems".