Learn method validation protocol components and how to include MVPs in your lab performance testing.
Why Should You Attend:
Method Validation Protocols show that you are doing what you say you are doing - as long as you document, document, document and report the data you have obtained.Method Validation Protocols (MVP's) are more than just necessary in the laboratory performing testing. This presentation will show what to include in your Method Validation Protocol, how to include it, and example acceptance criteria. This is your license to operate. Developing a stability indicating method is important. Use the FDA Guidances to be ready for what is expected.
Areas Covered in the Seminar:
- Background of Method Validation.
- Importance of Method Validation .
- What are FDA and Global Requirements?
- What are stability indicating methods?
- What is intermediate precision?
- Document the Process.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, Ros and Research Facilities Conducting Clinical Trials including:
- Laboratory Managers
- Laboratory Section Heads
- Senior Scientists
- Quality Assurance Managers and auditors
- Regulatory Compliance Associates and Managers
Instructor Profile:
Brian Jones, has over fifteen years experience in the pharmaceutical industry in many different capacities. As a research scientist, worked with the Analytical Development Department to improve the test methods being developed. And wrote and reviewed departmental procedures and technical reports. As a Quality Control chemist, performed qualitative and quantitative chemical and physical testing as specified by standardized procedures.
