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Topic Background:

Regulatory FDA and Notified Body Audits / Inspections are a fact of life. The same for self- or internal audits. A company's audit preparedness their conduct are growing in importance to regulatory health.

Why should you attend:

US FDA statements and actions indicate the initial and purpose of Part 11 "Add-on" inspections are being extended beyond what was to be a short term review of industry's response to Part 11. Using the field tested techniques presented in this webinar, an internal and/or supplier audit can provide much the same early warnings as a real FDA compliance CGMP audit. This webinar will provide test scripts and rationale for a "model" for company internal and supplier audits.

Description:

Each year U.S. FDA CGMP compliance inspections get tougher. In the EU and Asia, companies that pass notified-body inspections / audits with glowing reports fail their first FDA inspection and often also receive Warning Letters. Improvement in a company's internal and vendor audit program, adding remote or virtual audits to the company toolbox can greatly facilitate addressing this increased emphasis. And what should a company do to prepare for a CGMP inspection with the "Add-on Part 11" inspection elements. This webinar will look at basic areas of difference in emphasis. Also, these changes / differences in focus have a major impact on individual compliance objectives, efforts and measurements of success. Pre-, during- and post audit? We will further evaluate the chief areas of FDA CGMP compliance inspections and evaluate the actual and anticipated changes in emphasis, and how to better prepare with a company's supplemental remote audit program, as well as harmonize these audits to FDA expectations.

Areas Covered:

  • Key Requirements of US 21 CFR 820 device and 21 CFR 211 drug CGMPs and US FDA Inspections - QSR and QMSR Considerations
  • Vendor / Supplier Audits
  • Internal Audit Requirements
  • Key Features of the Part 11 "Add-on" inspection
  • Adapt the FDA "QSIT" (device) Inspection / Audit "Model"
  • Data Integrity
  • The Audit Schedule, Audit Plan, Draft Audit Report
  • Conduct of Post-audit Actions; Fomal Audit Report
  • Sample Audit Questionnaire and Worksheets
  • Vendor / Supplier Audits
  • LPA (Layered Process Audits)
  • Virtual Audits

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification

Who will Benefit:

  • R&D and Engineering
  • Company / Vendor Auditors
  • Senior management
  • Regulatory Affairs
  • Quality Assurance / QAE
  • Production
  • Consultants
  • All personnel tasked with any compliance audits, project management and new product development, and those who soon hope to be
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(10:00 AM ET – 4:00 PM ET)
  • 08:00 AM MT Introduction (personal / attendees / course information)
  • 08:10 AM MT Session 1 – FDA Compliance Inspections and Old QSIT (~79 slides)
    • Device CGMP Inspections – Old QSR, New QMSR; Combo Products
    • Pharma and Dietary Supplements CGMP Inspections
    • Principles from the old QSIT Requirements
    • Internal and Supplier Audits, Virtual Audits, LPA (Layered Process Audits)
  • 09:40 AM MT Break
  • 09:50 AM MT Session 2 – ISO 13485 (and ICH Q7) (~51 slides)
    • Notified-Body Audits prior to Marketing
    • ISO 13485 Device QMS, Internal / Supplier Audits
    • Design Control / Product Development
    • ICH Q7 / ISO 9001 GMP/ QMS for APIs Audits
  • 10:50 AM MT Session 3 – CAPA, FI, and RCA (~69 slides)
    • CAPA Definitions
    • Key CAPA Requirements; Change Control
    • CAPA Documents Templates
    • Failure Investigations, Root Cause Analysis Tools and Methods
  • 12:00 Noon MT Lunch Break
  • 12:20 AM MT Session 4 -- P&PC (~78 slides)
    • P&PC
    • FDA Requirements
    • Lean
    • Six Sigma
    • Problem Solving, Tools, Methodology
  • 01:25 PM MT Session 5 -- Management Responsibility (~40 slides)
    • FDA Requirements
    • Management and the QMS
    • Key Concerns / Responsibilities
  • 01:50 PM MT Summary / Conclusion, Q&A
  • 02:00 PM MT End
  • Note: Timings are approximate
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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 42 years’ experience in U.S. FDA-regulated industries, 28 as a full-time 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 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, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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