Development and Validation of Bioassays
Development and Validation of Bioassays

Course Description

This 3-day course will focus on factors to be considered in the design, development, and validation of bioassays. The course introduces terminology and important statistical tools and best practices. Examples and case studies will be provided to help solidify understanding on the topics of design and development, robustness, validation, and post-validation. Relevant pharmacopeial and EUA regulations will be highlighted.
  • Introduction to Bioassays
  • Guidance Documents on Bioassays
  • Design & Development
  • Robustness
  • Validation & Post Validation
  • Statistical Analysis Models
  • Examples / Case Studies
  • Recognize applicable terminology
  • Explain concepts of relative potency
  • Understand the bioassay life cycle
  • Recognize bioassay best practices
  • -- Explain bioassay design and development:
  • -- Fitness for use/potential challenges
  • -- Screening and optimization
  • -- Data and assumptions, variance heterogeneity
  • -- Goodness for fit and measurement of uncertainty
  • -- Normality, transformation and weighting
  • -- Validity/assay/system/sample suitable criteria
  • -- Acceptance criteria
  • Understand robustness (experimental design concepts)
  • Explain bioassay validation and post-validation:
  • Identifying and measuring significant sources of error
  • Experimental design and acceptance criteria
  • Statistical considerations involved

Development and Validation of Bioassays (US)

10 - 12 June 2024, Live Online Training
€1.850,00
Steven Walfish

Steven Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. Steven has experience applying statistical methods to analytical method verification and validation and stability analysis.

START TIMES

11:00 AM New York time

8:00 AM Los Angeles time

4:00 PM London time

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Course Description

This 3-day course will focus on factors to be considered in the design, development, and validation of bioassays. The course introduces terminology and important statistical tools and best practices. Examples and case studies will be provided to help solidify understanding on the topics of design and development, robustness, validation, and post-validation. Relevant pharmacopeial and EUA regulations will be highlighted.
  • Introduction to Bioassays
  • Guidance Documents on Bioassays
  • Design & Development
  • Robustness
  • Validation & Post Validation
  • Statistical Analysis Models
  • Examples / Case Studies
  • Recognize applicable terminology
  • Explain concepts of relative potency
  • Understand the bioassay life cycle
  • Recognize bioassay best practices
  • -- Explain bioassay design and development:
  • -- Fitness for use/potential challenges
  • -- Screening and optimization
  • -- Data and assumptions, variance heterogeneity
  • -- Goodness for fit and measurement of uncertainty
  • -- Normality, transformation and weighting
  • -- Validity/assay/system/sample suitable criteria
  • -- Acceptance criteria
  • Understand robustness (experimental design concepts)
  • Explain bioassay validation and post-validation:
  • Identifying and measuring significant sources of error
  • Experimental design and acceptance criteria
  • Statistical considerations involved

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Development and Validation of Bioassays (US)

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

Medical-Devices-Certificate-Course

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