Statistical process control (SPC) is a method of quality control that employs statistical methods to monitor and control a process. It is one of the fifteen subpart requirements of the US FDA’s QS Regulation, 21 CFR 82, the Medical Device cGMP. It can be a key tool in meeting the Production and Process Control (P&PC) requirements of those same CGMPs and those of the Drug CGMPs, 21 CFR 211. SPC used in P&PC and the required periodic quality system analysis helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste (rework or scrap). SPC provides advantages in any production process where the “conforming product” (product meeting specifications) output can be measured.

Areas Covered:-

• Required documentation / records
• SPC basics
• Regulatory requirements
• Required documentation / records
• Monitoring/control of equipment (production, test, and/or lab)
• Sample size justifications
• Verifications and/or Validations
• Trend analysis: NCMRs, Complaints, CAPAs
• Control Charts, GR&R, CpK, and other common statistical / SPC tools
• Early warning of process changes

Why You Should Attend:-

This webinar will define what is the US FDA’s expectation for the use of statistical techniques, e.g., 21 CFR 820.25, for establishing, controlling, and verifying the acceptability of process capability and product characteristics, sampling plan justifications for product acceptance or validation, and other studies. Increasingly regulatory agencies require trend analysis for non-conformances, complaints, and CAPAs as part of CGMP compliance. Subject areas considered are:

• SPC in production, test, and lab equipment
• Sampling plan justification
• Verifications and validations
• Trending: Non-conformances, complaints, and CAPAs

Who Should Attend:-

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Validation Departments
• Marketing Departments
• Documentation Departments