Reducing Variability in Cell-Based Methods Using Process Controls

Speaker

Instructor: Gwen Wise Blackman
Product ID: 705933
Training Level: Intermediate

Location
  • 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.
Purchase option for this webinar is currently unavailable. Please contact our Customer Care for more info. Webinar All Access Pass Subscription

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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.

Follow us :

 

 

Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method