Auditing laboratories Performing Cell-Based Methods

Gwen Wise-Blackman, Ph.D. 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 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, and Quality Assurance. Dr. Wise-Blackman has a Bachelor of Science degree in biology from M.I.T and a Ph.D. in Pharmacology from the University of Virginia. She is a member of ASQ and AAPS.  

This course covers the following topics: a brief overview of FDA and EMEA guidelines, how to establishing objectives of the audit/inspection, identifying the audit team, creating and reviewing quality agreements, planning for the audit/inspection, determining which key systems and key SOPs to review, assessing and understanding the impact of differences, Setting the timing and the agenda, communicating findings and follow-up and closure of the audit/inspection.

Cell-based laboratories are responsible for analytical data for biopharmaceutical products. Included in this analysis are cell-based methods that determine the potency of the product. This webinar discusses key points to assess during the preparation and performance of GMP laboratory inspections/audits. Included in this presentation are suggestions for specific items to review. Understanding the process and steps of the audit is also a key learning objective of this webinar. The need to analyze differences for their potential impact on quality is necessary when changes to procedures between your facility and the contract facility are uncovered. This webinar will address the steps in the audit that help identify issues as well as steps to take when negotiating changes to procedures. This webinar is useful for auditing contract laboratories as well as laboratories at the sponsor site. The quality or laboratory professional who attends this webinar will gain knowledge useful in addressing maintaining a quality method in a cell-based laboratory.

Learning Objectives

  • Regulatory Agency Expectations
  • Identifying Additional Audit/Inspection Topics Specific for Cell-Based Laboratories
  • Establishing and communicating the audit plan
  • Identifying potential quality issues
  • Presenting findings

Who Should Attend

  • Laboratory analysts and managers
  • Quality assurance scientists and managers
  • Quality control scientists and managers
  • Development and validation scientists
  • Regulatory Affairs
  • Consultants
  • $249.00