Layered Process Audits for USFDA Regulated Industries

How can this new internal inspection tool – the Layered Process Audit (LPA) – be used to assist in FDA regulatory compliance, and in meeting requirements for an annual internal cGMP system audit / inspection.

Each year companies are to perform a complete review /inspection / audit of their quality management system and its ability to meet the current GMP’s (cGMPs). How can the new Layered Process Audit concept be adapted to assist companies to proactively address areas of GMP concern, while simultaneously fulfill their annual internal audit requirements. The continual major shift in emphasis of the U.S. FDA cGMP compliance audits, clinical trial expectations, product submissions and company response requirements, all point toward the need for more on-going monitoring / inspecting / auditing of a company’s cGMP system, with real-time feed back increasingly importan. Since all regulatory areas come under evaluation by the FDA, they need to be frequently revisited by a company’s QA/RA and its senior management. There is “no business as usual”.

This change in focus has a major impact on intrepretation of individual compliance objectives, cGMP objectives, and measurements of success. The principles of a Layered Process Audit adapt themselves to this changing environment. Recent FDA guidance on process validation stresses the need to maintain a process in a state of validation control, which further lends itself to the LPA. This webinar will examine / review FDA’s “must-have’s” for corporate cGMP compliance and how they can be readily incorporated into the LPA process.

Why You Should Attend:

This webinar will primarily examine the two most visible cGMPs, Drugs and Devices, and related FDA initiatives, to see where LPA could assist compliance. Such a review will focus on the broad range of issues a company’s senior management and QA/RA need to consider in their annual Internal Audit Program and Management Review of their existing quality management system – with the goal of isolating key areas where the LPA can be logically and easily implemented. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what the FDA and industry need to do internally.

Critical cGMP compliance concerns and areas for required review or related industry problem areas that are amenable to the LPA methodology will be considered. Implementation examples and suggested form formats / templates will be presented and discussed. LPA-assisted locating and addressing of weak spots proactively will also prove a company is “in control”, prepare proactively for an FDA inspection, and assist in auusring accurate submissions to the Agency, and in any needed remediation efforts.

Areas Covered in the Session :

  • Device cGMPs (21 CFR 820)
  • What is LPA
  • Device, Pharmaceutical and Related CGMP Areas of Possible LPA Focus
  • Implementation of LPA
  • Sample LPA Worsheets
  • Performing an LPA
  • Disposition of LPA Findings
  • Review for Thoroughness – Filling in the Blanks
Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Documentation Departments
  • Comsultants


John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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 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 published 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.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance