Overview
This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.
This webinar will define what are the US FDA's expectation for Production and Process Control / Product Realization, the use of statistical tehniques, 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 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 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 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.
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
Faculty 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 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.
