ComplianceOnline

Expert Profile


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.

Trainings by Expert

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training
Category: Drugs and Chemicals (Pharma) , Clinical Research , Biotechnology , Testing and Validation , Documentation and IT , Audits & Inspections , Trial Design and Management , Quality & Safety , Technologies and Processes , Biologics and Biosimilars , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Validation of Complex Cell-Based Potency Methods
Category: Biotechnology , Testing and Validation , Documentation and IT , Quality & Safety , Technologies and Processes , Cellular and Gene Therapy , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , QA/QC

21 CFR 111 GMP Dietary Supplement Laboratory
Category: Drugs and Chemicals (Pharma) , All FDA Regulated Industry , Quality and Safety , Food & Dietary Supplements , Manufacturing & Contamination control , Food Safety & Quality , Life sciences QA/QC , Life Sciences , Regulatory Affairs , QA/QC

Implementing a Stability Program for a Biologic
Category: Drugs and Chemicals (Pharma)

Reducing Variability in Cell-Based Methods Using Process Controls
Category: Drugs and Chemicals (Pharma) , Biotechnology