Using SPC and Process Data to Support Quality, Stability, and Manufacturing Decisions

This webinar is intended to provide guidance regarding CGMPs production controls using SPC / six sigma / statistical controls for use in device, pharmaceutical and other CGMP manufacturing industries, and for use by contract manufacturers that support the regulated medical products industries.

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 subpart requirements of the US FDA's QMSR, 21 CFR 82, the Medical Device CGMP as well as other CGMPs.  It can be a key tool in meeting the Production and Process Control (P&PC) requirements of those same 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,  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 / Six Sigm4 / Control Charts in production, test and lab equipment
• Sampling plan justification
• Verifications and validations 
• Trending:  Non-conformances, complaints, and CAPA. Incorporation into the production process.

| AREAS COVERED

• Statistical Process Control Overview 
• 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
• Variation, Common Cause, Special Cause
• 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, Principal of J.E. Lincoln and Associates LLC, has over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide.  He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files.  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, chapters in books including RAPS (6 chapters in two textbooks on validations),  conducted workshops and webinars worldwide. John is a graduate of UCLA.