This Validation of Bioanalytical Assays webinar describes logical approaches to efficiently develop assays that will deliver quality data.
Why Should You Attend:
Strategic management of the pharmacokinetic profile of a drug is a critical determinant of therapeutic success in the clinic. Successful development and validation of the bioanalytical assays that support these studies are key components to the process. This presentation describes logical approaches to efficiently develop assays that will deliver quality data. The main body of the talk reviews and compares current regulatory and industry guidelines with a goal to preparing a compliant validation protocol and method. The seminar also analyzes critical validation parameters, describes common technical pitfalls and suggests solutionsAreas Covered in the Seminar:
- Expectations of the GLP (GCLP) environment.
- Effective assay development.
- Maximizing precision and accuracy.
- Minimizing matrix effects.
- Setting specifications for the validation protocol.
- Sample re-analysis plan.
- Managing the life cycle of the bioanalytical assay.
Who Will Benefit:
- Bioanalytical scientists
- Pharmacokinetic specialists
- Biotech R&D staff
- Clinical research associates
- Validation specialists
- Project Management
- Regulatory staff
- QA/QC
- Outsourcing Professionals
- Biopharmaceutical Consultants
Course Provider
Ana Menendez,
