Medical Products Manufacturing Operations, Regulations and Controls


Instructor: John E Lincoln
Product ID: 706958
Training Level: Intermediate

  • 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.
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This webinar will define what is required to setup and run a compliant medical products manufacturing operation. What are the US FDA's expectations for the product line under the CGMPs, its equipment, tests, personnel, material control, use of P&PC (production and process controls), including statistical techniques, sampling plan justifications for product acceptance or validation and other studies.

Subject areas considered are:
Setting up the production line; Tools - flow charts, Cause and Effect diagrams ...; Implementing the CGMPs; Documentation; Training; Validation of Process / Equipment; Internal Audits; Continuous monitoring -SPC / six sigma; Sampling plan justifications; Trending: Non-conformances, complaints, and CAPAs.

Why Should You Attend:

How does a project leader / manufacturing engineer / QA / manufacturing supervisor and similar personnel tasked with setting up a new or changed production line go about completing that assignment - to end up with a CGMP-compliant operation satisfying regulatory, product, and business requirements. How to perform Verification and Validation on the production system. How to maintain the production system in a state of validated and statistical control using various SPC / Six Sigma and similar tools. 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. P&PC in drug and device manufacturing under the CGMPs 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:

  • Initial steps in establishing the system: Operations and Documentation

  • Recommended Planning and Set-up Tools
  • Regulatory requirements of P&PC in the CGMPs

  • Personnel and training
  • Monitoring / control of equipment (production , test, and/or lab)
  • Sample size justifications

  • Verification and/or Validations
  • Trend analysis: NCMRs, Complaints, CAPAs

  • Required documentation / records

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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