2024 - P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3

Overview
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 for non-conformances, complaints, and CAPAs as part of CGMP compliance. Subject areas considered are:
SPC / 6 sigma in production, test and lab operations Failure Investigations
The role of Verifications and validations
Trending: Non-conformances, complaints, and CAPAs
Why Should You Attend
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 suboart 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.
Webinar Takeaway
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
Who Will Benefit
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