Conducting Remote Medical Device QMS Audits Training

Why Should You Attend:

US FDA statements and actions indicate the past ways of doing things are no longer be acceptable. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. Pressure for "better science" is only one example. Use of remote or virtual can fill in the gap between actual site visits and a "paper" / questionare audit, for a company's remote sites and low to moderate risk vendors / suppliers. Using the field tested techniques presented in this webinar, a remote or virtual audit can provide much the same results as an on-site audit, but with reduced resources and timelines and still follow the US FDA "models" for company internal and supplier audits.

Each year U.S. FDA CGMP compliance inspections get tougher. In the EU and Asia, companies that pass notified-body inspections / audist 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. This webinar will look at the basic area of difference in emphasis. Also, these changes / differences in focus have a major impact on individual compliance objectives, efforts and measurements of success. Can remote audits help fill the gap? What are the steps to a successful remote audit? Pre-, during- and post audit? We will furtheer 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 in the Webinar:

• The key purposes of the internal- and vendor-audit program.
• Key Requirements of US 21 CFR 820 CGMPs/QMS and ISO 13485
• Adapt the FDA "QSIT" (device) Inspection / Audit "Model"
• A "Typical" FDA Inspection, replicated virtually
• Successful remote / virtual Internal and Vendor Audits
• Data Integrity
• The Remote Audit Schedule, Audit Plan, Draft Audit Report
• Conduct of the Remote Audit, Post-audit Actions. Fomal Audit Report
• Sample Remote Device Audit Questionaires and Worksheets
• Supplemental video tours, e-documents, picture copies

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

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 ptublished 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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