Curriculum
Course Description:
This webinar will review how dissolution and drug release testing are used to demonstrate the consistency of pharmaceutical product performance within and across batches of critical medicines.
Discussion topics:
- Rigorous development of the USP DPVS
- Potential sources of variability in dissolution testing related to equipment operation and setup
- Risks and implications of relying solely on mechanical calibration or PVT
- Criteria for a “fully qualified” dissolution instrument according to USP specifications
- Impact of choosing an “either-or” approach for mechanical calibration and PVT
Who should participate:
- Pharmaceutical Manufacturers – Companies producing oral dosage form medications, including end-users such as analysts, scientists, and decision-makers at director, manager, and executive (C-suite) levels.
- Regulatory Authorities – Agencies and inspectors responsible for compliance and quality standards in drug development and manufacturing.
- Equipment Providers – Manufacturers and suppliers of dissolution testing instruments and related technologies.
Access Duration:
Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.