This method validation training will address the regulatory requirements which apply at the various stages of product development, and suggest proven strategies for compliant and phase-appropriate analytical method validation.
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.
The training will cover both small molecule test methods and biotechnology assays, and suggested parameters to validate in each case. The documentation associated with test method validation will also be reviewed.
The employees who will benefit include:
Why Should You Attend:
As products are developed from R&D through pre-clinical, clinical and commercial phases, the requirements for analytical test method validation also evolve to meet the increasing regulatory requirements. It is important to know when to do what - too much or unnecessary validation is costly and can delay development programs, while insufficient validation can mean rejection of an application.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.
The training will cover both small molecule test methods and biotechnology assays, and suggested parameters to validate in each case. The documentation associated with test method validation will also be reviewed.
Areas Covered in the Seminar:
- 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 prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and manufacturing services will also benefit.The employees who will benefit include:
- End-users responsible for testing
- QA managers and validation personnel
- Analytical development managers and personnel
- Senior Quality, Facilities and R&D Management
- Quality Control staff
- Quality system auditors
Course Provider
Richard Poser(PhD),
