Analysing Bioassays and Immunoassays - Online Academy
This course will build on your understanding of bioassays and immunoassays, helping you to come to grips with assay development, troubleshooting, performance management and more. Over 10, detailed modules you will understand key techniques for validation design and implementation and how to align to regulatory standards. In addition, you will become familiar with biostatistics and key data analysis methods.
Suitability - Who should attend?
This course is designed for all individuals who develop, validate, perform or monitor bioassays or immunoassays. Individuals who develop assay methodologies, assign computational and analysis criteria, measure and validate performance characteristics, perform, evaluate and troubleshoot problem assays, or are responsible for the quality of the data will benefit from the lessons and examples presented. Attendees should have a basic understanding of bioassays or immunoassays. Relevant departments may include:
- Quality Control (QC)
- Quality Assurance (QA)
- Cleaning Validation
- Regulatory Affairs
- Process Development
- Product Development
Outcome / Qualification etc.
- Understand the basic principles of biological assays
- Build measurement systems, consider assay layout and select mathematical curve models to analyse your data
- Learn how to develop bioassays and immunoassays including the necessary biostatistics
- Validate and qualify your choice of model
- Validate an assay to meet regulatory requirements
Training Course Content
- Module 1: Basics of biological assays
- Module 2: How to develop an assay - immunoassays
- Module 3: How to develop an assay - immunoassays, continued
- Module 4: How to develop an assay - bioassays
- Module 5: Biostatistics
- Module 6: Validation of an immunoassay
- Module 7: Validation of a bioassay
- Module 8: Assays in immunogenicity
- Module 9: Validation versus qualification
- Module 10: Assay monitoring and troubleshooting
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
85% had applied content during the course to their role
PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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