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
- 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
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.
