AQP / APQP in Medical Products Manufacturing Operations

Description

This webinar will define what is required to setup and run a compliant medical products manufacturing operation utilizing the key principles of APQP, which incorporate many basics of P&PC, et al. 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 AQP / APQP principles adapted to CGMP-compliant operation satisfying regulatory, product, and business requirements? How to perform Verification and Validation and maintain the production system in a state of validated and statistical control using various APAP / SPC / Six Sigma and similar tools to monitor and control a process. AQPA can mesh with existing principles to meet the Production and Process Control (P&PC) requirements of the Drug, device and other CGMPs, 21 CFR 211. These techniques help to ensure that the process operates efficiently, producing more specification-conforming products with less waste (rework or scrap). They provide 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

• What is AQP and APQP?

• 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
• AQP and APQP - Advantages in CGMP compliance

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

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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