P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3

This webinar will define what are the US FDA's expectation for Production and Process Control / Product Realization, the use of statistical techniques, 6 sigma, SPC, for establishing, controlling , and verifying the acceptability of process capability and product characteristics, product acceptance or validation and other studies. Non-conformance, OOS, deviations Failure Investigations, and Root Cause Analysis, PDCA, DMAIC, and similar project drivers to improvement, A# and similar dash boards.

Increasingly regulatory agencies require trend analysis fo non-conformances, complaints, and CAPAs as part of CGMP compliance. Subject areas considered are:

• SPC / 6 sigma in production, test and laboperations Failure Investigations
• The role of Verifications and validations
• Trending: Non-conformances, complaints, and CAPAs

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 CGMPS. 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 as prt of the requirements for P&PC in drug and device manufacturing under the CGMPs. They help 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.

• SPC / 6 Sigma basics
• Regulatory requirements of P&PC in the CGMPs
• Required documentation / records
• Monitoring / control of equipment()production , test, and/or lab)
• Failure Investigation and Root Cause Analysis; Tools
• Verifications and/or Validations
• Trend analysis: NCMRs, Complaints, CAPAs
• Control Charts, GR&R, CpK, other common statistical / SPC tools
• Early warning of process changes

• Senior management in Devices, Pharma, Combination Products
• QA / RA
• Medical products V&V teams
• R&D
• Engineering
• Production
• Operations
• Marketing
• Consultants; others tasked with medical product development, manufacturing, process / product / data analysis, and V&V responsibilities

Instructor Profile:

John E Lincoln

Principal, J E Lincoln and Associates

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 as a full-time 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 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, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.