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Validity : 06th Feb'25 to 16th Feb'25
CGMP Manufacturing Methods - PPC and SPC
- Required documentation/records
- SPC basics
- Regulatory requirements of P&PC in the CGMPs
- 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, and other common statistical / SPC tools
- Early warning of process changes
Overview of the webinar
This webinar will define what are the US FDA's expectations for the use of statistical techniques, e.g., 21 CFr 820.25, 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 in production, test, and lab equipment
- Sampling plan justification
- Verifications and validations
- Trending: Non-conformances, complaints, and CAPAs
Who should attend?
- Senior management in Devices, Pharma, and 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
Why should you attend?
Statistical process control (SPC) is a method of quality control that 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 is used as part 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.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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, Technical Files, CAPA systems and analysis. 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 ptublished 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. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.