GMP Auditing of Facilities Performing Cell-Based Methods
Duration : 60 Minutes
Gwendolyn Wise-Blackman,
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), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method De Read more
Laboratories that perform cell-based methods must meet stringent GMP guidelines for analytical procedures. In addition, standard operating procedures that specifically address working with cells should be in place to maintain control of a live assay system. GMP inspections should cover additional topics in cell-based laboratories to confirm procedures are sound from a regulatory perspective.
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 will discuss 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 and negotiating changes to procedures. The quality or laboratory professional that attends this webinar will gain knowledge useful in addressing maintaining a quality method in a cell-based laboratory.
Course Objective:
• Regulatory agency expectations
• Identifying additional audit/inspection topics specific for cell-based laboratories
• Establishing and communicating the audit plan
• Identifying the audit team
• Assessments during the walk-throughs
• Setting the timing
• Identifying potential quality issues
• Presenting findings
• Negotiating responses
Course Outline:
Topics covered includes:
• Brief overview of FDA and EMEA Guidelines
• Establishing objectives of the audit/inspection
• Identifying the audit team
• Review of quality agreement(s)
• Preparing the audit/inspection plan
• Key systems to review
• Key SOPs to review
• Understanding the impact of differences
• Setting the timing and the agenda
• Communicating findings
• Follow-up and closure of the audit/inspection
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Compliance Professionals
• Validation Scientists
• Quality Assurance
• Quality Control
• Regulatory Affairs
• Laboratory Managers
• Assay Development Specialists
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
