Statistical Process Control (SPC) and Control Charts – In Accordance with Latest FDA Expectations
Duration : 90 Minutes
John E. Lincoln,
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide. He specializes in quality assuranc Read more
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
Course Outline:
• Required documentation / records
• SPC basics
• Regulatory requirements
• Required documentation / records
• Monitoring / control of equipment (production, test, and/or lab)
• Sample sizejustifications
• Verifications and/or Validations
• Trend analysis: NCMRs, Complaints, CAPAs
• Control Charts, GR&R, CpK, other common statistical / SPC tools
• Early warning of process changes
Who Will Benefit:
• 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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
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