Statistical Process Control (SPC) and Control Charts - In Accordance with Latest FDA Expectations

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

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

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

Course Director: JOHN E. LINCOLN  

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.