Using SPC and Process Data to Support Quality, Stability, and Manufacturing Decisions
Learn how SPC, Six Sigma, and process data support CGMP production controls — sampling plan justification, verification/validation, and trend analysis for non-conformances, complaints, and CAPAs.
Instructor
John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
What You'll Learn
About the event
About this event
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
Curriculum
Requirements
- Quality Assurance, Quality Control, and Regulatory Affairs professionals
- Applicable to Manufacturing, Engineering, Operations, Production, and Validation roles
- Relevant to Research and Development, Marketing, and Documentation departments
Who Should Attend
This webinar is designed for 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, and Documentation Departments.
Areas Covered
Meet Your Instructor
John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
John E. Lincoln 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, 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, and Technical Files. He has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). John has prior experience in military, government, electronics, and aerospace industries. He is a peer-reviewed author, teacher, and speaker, and a graduate of UCLA.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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