Auditing Laboratories Conducting Assays Supporting Biologics

Topics

• Quality Agreements
• Regulatory agency expectations
• Establishing and communicating the audit plan
• Identifying additional audit/inspection topics specific for cell-based laboratories
• Assessments during the walk-through
• Identifying the audit team
• Identifying potential quality issues
• Setting the timing
• Negotiating responses
• Presenting findings

Who should Attend

Attendees with responsibilities in:

• Biopharmaceutical Regulatory Affairs
• Pharmaceutical Regulatory Affairs
• Consultants
• Pharmacists
• Biopharmaceuticals
• Pharmaceuticals
• Natural Products
• Botanicals