🎤  John E. Lincoln    |  📅  Recording Available    |  🕒  90 Minutes

Areas Covered in the Session :

  • 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, other common statistical / SPC tools
  • Early warning of process changes


Statistical process control (SPC) is a method of quality control which 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’s. 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.

Why You Should Attend:

This webinar will define what are 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
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