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 820, 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 Sigma / Control Charts in production, test and lab equipment; Sampling plan justification; Verifications and validations; Trending: Non-conformances, complaints, and CAPA, and incorporation into the production process. Code: FDB3755