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Subscribe NewsletterValidation of Analytical Methods and Procedures
Product Id
:
600208
Overview: Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data.
Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This seminar will provide a good understanding on how to effectively prepare, conducts and document method validation experiments for FDA and ISO 17025 compliance.
Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This seminar will provide a good understanding on how to effectively prepare, conducts and document method validation experiments for FDA and ISO 17025 compliance.
Reference material for easy implementation:
- SOP: Validation of Analytical Methods
- Checklist: Validation of Analytical Methods
- 65-page Primer: Validation of Analytical Methods
Areas Covered in the Session:
- FDA regulations and guidelines
- Examples of warning letters and how to avoid them
- Requirements of ISO 17025
- Developing an SOP for method validation
- Development of a validation plan
- Defining parameters and acceptance limits
- Validation of standard and compendial methods
- When to revalidate after method changes
- Transferring a method to routine
- Using software for automated method validation
- Documentation for the FDA, other agencies and for ISO 17025
Who will benefit:
- Laboratory managers and supervisors
- GLP/GCP/GMP auditors
- ISO 17025 auditors
- QA/QC managers and personnel
- Analysts and other laboratory staff
- Regulatory affairs
- Training departments
- Consultants