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

Speaker

Instructor: John E Lincoln
Product ID: 706963
Training Level: Intermediate

Location
  • Duration: 90 Min
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.
RECORDED TRAINING
Last Recorded Date: May-2024

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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Description

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 laboperations 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 reqirements 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.

Areas Covered in the Webinar:

  • 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
Instructor Profile:
John E Lincoln

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.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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