Course Overview:
This intensive one-day workshop provides a practical and technical overview of the analytical method validation lifecycle, covering the journey from analytical procedure development to validation, transfer, routine monitoring, and Out-of-Specification (OOS) management.
The workshop is aligned with ICH Q2(R2) requirements and the Quality by Design (QbD) principles under ICH Q14. Participants will gain technical knowledge on defining and applying the Analytical Target Profile (ATP), preparing validation protocols and reports, and developing supporting documentation in a regulatory-compliant manner.
Course Outline:
Analytical Procedure Development
- Analytical Procedure Development under ICH Q14
- Science and risk-based approach for GMP compliance
- Application of the Analytical Target Profile (ATP)
- Method development, verification, and validation considerations
Analytical Method Validation
- Practical insights into analytical method validation
- Preparing validation protocols, reports, and supporting documentation
- Regulatory expectations for analytical method validation
- Ensuring analytical methods are fit for their intended purpose
Method Performance and Lifecycle Management
- Integration of development, validation, transfer, and routine monitoring
- Managing Out-of-Specification (OOS) situations
- Ensuring continued analytical method performance
- Common regulatory queries on AMV
Please refer to the brochure for the full agenda and speaker details.
10 CPD points awarded by the Malaysian Pharmacists Society (MPS).
Participants
This workshop is suitable for personnel involved in analytical method development, validation, quality control, regulatory affairs, and dossier preparation.
- Validation and technical personnel
- QC personnel
- R&D personnel
- Regulatory Affairs Executives
- Regulatory Affairs Managers
- Personnel involved in dossier preparation
