Speaker Profile
Gwendolyn Wise-Blackman
Principal Consultant, Gwen Wise-Blackman Consulting, LLC
Gwen Wise-Blackman, Ph.D. has over 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 where she successfully managed multiple projects and held positions of increasing accountability for scientific and quality expertise. Currently she is the owner of Gwen Wise-Blackman Consulting, LLC, a biopharmaceutical consulting firm.
Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, Ligand Binding Methods, Technology Transfer, GxP Regulations, Training, Audting, 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.
Auditing Laboratories Conducting Assays Supporting Biologics
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Auditing Laboratories Conducting Assays Supporting Biologics
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits. Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Bioanalytical Method Validation
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Auditing Laboratories Conducting Assays Supporting Biologics
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Bioanalytical Method Validation
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Implementing Process Controls for Cell-Based Assays
Bioassays are used to demonstrate that a biological product performs per the stated function and potency.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Bioanalytical Method Validation
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Bioanalytical Method Validation
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Implementing Process Controls for Cell-Based Assays
Bioassays are used to demonstrate that a biological product performs per the stated function and potency. Typically, these methods are performed in living systems. Cell-based methods can have inherent variability due to the nature of living systems. Minimizing potential variability can be achieved through careful documentation and analysis of assay performance on control charts.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecules, bioassays have unique requirements due to the variable nature of some critical components.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Auditing Laboratories Conducting Assays Supporting Biologics
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
Auditing Laboratories Conducting Assays Supporting Biologics
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits. Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
Auditing Laboratories Conducting Assays Supporting Biologics
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
3-Hour Virtual Seminar on Bioanalytical Method Validation
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View Details
Implementing Process Controls for Cell-Based Assays
Bioassays are used to demonstrate that a biological product performs per the stated function and potency.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
3-Hour Virtual Seminar on Bioanalytical Method Validation
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
3-Hour Virtual Seminar on Bioanalytical Method Validation
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View Details
Implementing Process Controls for Cell-Based Assays
Bioassays are used to demonstrate that a biological product performs per the stated function and potency. Typically, these methods are performed in living systems. Cell-based methods can have inherent variability due to the nature of living systems. Minimizing potential variability can be achieved through careful documentation and analysis of assay performance on control charts.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details
Validation Challenges for Bioassays
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecules, bioassays have unique requirements due to the variable nature of some critical components.
Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View Details