Development & Validation for Bioassays

Venue: Four Points by Sheraton Toronto Airport

Location: Mississauga, Ontario, Canada

Event Date/Time: Sep 10, 2007 End Date/Time: Sep 11, 2007
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Description

Development & Validation for Bioassays

Strategies for Effective Method Design and Validation for Producers of Biological Products

With participation from USP

A TWO-DAY INTERACTIVE COURSE WITH WORKSHOPS & DISCUSSIONS ON:

- What are bioassays? – definition of terminology used
- Why are they required? – scientific and regulatory requirements
- Examples of bioassays with descriptions of analytical instrumentation requirements
- Reference standards for bioassays
- Strategies for minimising variability
- Design and validation of bioassays
- Setting specifications for bioassays
- Use of bioassays in pre-clinical/clinical sample analysis
- Quality Assurance viewpoint on Bioassays
- Alternatives to proliferation assays (new technology, signaling pathway assays, etc.).
- Planning for Assay Development
- What is a Biological Assay Versus a Chemical Assay?
- Use of Compendial Procedures and Those from the Literature
- Considerations During the Assay Development Process
- Test Method SOPs
- Timing and Verification of Training
- Management of Assay Development and Validation
- Applying Process Controls
- Determining Numbers of Replicates
- Defining Accuracy and Precision
- Determining Range, Linearity, Specificity & Sensitivity
- Ruggedness and Robustness
- Minimizing Analyst and Instrument Variability
- Parallel Line Bioassays
- Determination of Titer and Other Microbial Tests
- Preparing a basic control chart

Distinguished Course Leaders

Dr. Steven S. Kuwahara
Dr. Tina S. Morris
Dr. Gwendolyn Wise-Blackman

Venue

6257 Airport Road
Mississauga
Ontario
Canada
MORE INFO ON THIS VENUE

Additional Information

Who Should Attend: This two day course, case studies and workshop program is directed toward Managers, Supervisors, Analysts, and Associates in the Biologics, Biopharmaceutical, Biotechnology, and allied industries with daily responsibilities in the following areas: - Quality Assurance - Quality Control - Quality System Auditors - Regulatory Affairs - Analytical Development - R&D - Project Management - Statisticians - Validation - Compliance - Manufacturing and Process Development Registration Fee: $825.00 + GST (6%) - Multiple Registrations: Send five attendees and the sixth is FREE!

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