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This seminar will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation. We will cover the FDA, ICH and USP requirements, and illustrate the components of validation and ways to expedite the validation process. We will review both small molecule test methods and biotechnology assays, and suggested parameters to validate in each case. The documentation associated with test method validation will be reviewed.
Why should you attend:
The analytical test methods used in support of drug development, product testing, stability, pre-clinical and clinical research must be qualified and/or validated for use. Any data filed with a regulatory agency from an unqualified test method is suspect and may be rejected or force regulatory sanctions, including product recall. Many R&D methods also should be qualified to preserve the investment of time and money spent in a development program. This seminar will describe industry-standards for test method qualification and validation to meet these requirements.
Areas Covered in the Session:
- Regulatory requirements for test method validation
- Phase-appropriate test method validation
- Elements of test method validation
- FDA, ICH and USP requirements for validation
- Documenting test method validation
Who Will Benefit: This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. The employees who will benefit include:
- QC managers and personnel
- QA managers and personnel
- Information Technology managers and personnel
- Validation specialists
- Analytical Scientists