What to expect from US FDA and other external inspections/audits. How to conduct internal and supplier/vendor audits. Factor US FDA compliance inspection emphasis into the company's audit preparedness and replicate key points for internal and supplier audits.
Using the field tested techniques presented in this seminar, an internal and/or supplier audit can provide much the same early warnings as a real FDA compliance cGMP audit. This seminar will povide test scripts and rationale for a'model' for company internal and supplier audits. It will describe a'typical' US FDA inspection, and points to replicate with an internal audit or supplier audit. The Notification, the Agenda/Audit Plan, daily reporting, Draft Final Report, Formal Final Report, Templates/examples. The company internal audit as a training tools. What to concentrate on when a notice of a regulatory inspection is first received.
Using the field tested techniques presented in this seminar, an internal and/or supplier audit can provide much the same early warnings as a real FDA compliance cGMP audit. This seminar will povide test scripts and rationale for a'model' for company internal and supplier audits. It will describe a'typical' US FDA inspection, and points to replicate with an internal audit or supplier audit. The Notification, the Agenda/Audit Plan, daily reporting, Draft Final Report, Formal Final Report, Templates/examples. The company internal audit as a training tools. What to concentrate on when a notice of a regulatory inspection is first received.
Why You Should Attend:
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, and 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. This seminar 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 internal audit program, as well as harmonize these audits to FDA expectations re: Part 11, cybersecurity, et al.Course Content
DAY 1 (10 AM to 4 PM)- The key purposes of the internal- and vendor-audit program.
- Key Requirements of US 21 CFR 820 device and 21 CFR 211 drug cGMPs
- 21 CFR Part 11
- Adapt the FDA 'QSIT' (device) Inspection/Audit 'Model'
- Key Internal Audit Elements
- Cybersecurity
- Data Integrity
- The Audit Schedule, Audit Plan, Draft Audit Report
- Conduct of Post-audit Actions; Formal Audit Report
- Sample Audit Questionnaires and Worksheets
- Suppler and Quality Agreements' Audits
- Key Vendor Audit Elements
- Required Documentation
- QSIT focus.
Speakers
John E. LincolnJohn 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 of which 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 FDA-compliant new product development and to market issues, quality assurance, regulatory affairs, QMS problem remediation and FDA responses, 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 VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles and book chapters in peer reviewed publications (5 chapters in RAPS textbook on V&V) conducted workshops and webinars worldwide on virtually all cGMP issues. John is a graduate of UCLA.
