Reducing Variability in Cell-Based Methods Using Process Controls

Instructor: Gwen Wise Blackman
Product ID: 705933
Training Level: Intermediate
  • Duration: 60 Min
This webinar will provide a general overview of the cell-based methods using process controls as well as specific examples of successful monitoring of cell-based methods leading to reduced assay failures.
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Why Should You Attend:

Cell-based methods are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecules, bioassays that use cells have unique requirements due to the variable nature of critical components. Although some variability may be inherent, careful attention to setting appropriate limits and to robust qualification of critical components enhances the likelihood of success. Minimizing potential variability can be achieved through careful documentation and analysis of assay performance on control charts. Monitoring numerous parameters helps assist laboratory scientists, laboratory managers, QC, and QA personnel identify and manage trends that could lead to OOS/OOT results. Since the number of parameters evaluated is dependent on the cell-type, assay-type, and number of critical component or reagents.

Areas Covered in the Webinar:

  1. Understanding the nature of cell-based methods
  2. Determining critical components to monitor
  3. Use of DOE to define assay limits
  4. Setting appropriate limits for reagents
  5. Reagent supply and sample handling
  6. Pre-test of critical reagents
  7. Testing robustness /ruggedness/ selectivity/specificity prior to validation
  8. Managing analyst variability
  9. Designing control charts
  10. Setting alert and action limits
  11. Writing a detailed method

Who Will Benefit:

  1. Quality Assurance
  2. Quality Control
  3. Lab Managers
  4. Development Scientists
  5. Validation Scientists
  6. Laboratory Analysts
Instructor Profile:
Gwen Wise Blackman

Gwen Wise Blackman
Manager, Salix Pharmaceuticals

Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, Immunogenicity, Technology Transfer from client sites, and Quality Assurance. Dr. Wise-Blackman has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from the University of Virginia. She is a member of ASQ and AAPS.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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