Statistics for GMP Auditors 2013

Topics

• Sampling by an Auditor-A Proposed Method
• Acceptance Sampling Plans for Attributes
• Graphing Time-Based Process Data & Recognizing Trends (or "out of trends")
• Sampling API Shipments/Containers and Composite Sampling
• Blend Uniformity Statistics
• Process Capability Indices and Inferring PPM Nonconforming
• Outlier Statistics Used in Some QA Investigations
• Uniformity of Dosage Units Statistics
• Reserve and Retain Samples in the US and EU GMP Regulations
• Statistical Acceptance Criteria for Analytical Method Technology Transfer
• Examples of Audit Observations for Improper Sampling Plans or Statistics Usage

Who should Attend

• Persons asked to "guest" participate in GMP audits
• Full-time GMP Auditors
• Quality Assurance and Compliance Management
• Operations, Quality Control, and other personnel who interact with GMP auditors or who are their stakeholders
• Regulatory Inspectors/Investigators
• Consultants
• Statisticians
• Product Managers