ComplianceOnline

Processes for 510(k) Clearances for In Vitro Diagnostic/IVD Device Products via FDA-CDRH

Instructor: Alfredo J Quattrone
Product ID: 700442
Training Level: Advanced
  • Duration: 60 Min

recorded version

$149.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jun-2007

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

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Read Frequently Asked Questions

This 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.

Discussion points:

  • CDRH’s "Device-Advice" and "OIVD" Website Starting Ponts
  • Importance of FDA’s Guidance Documents, of International Standards; and FDA Published "Summaries" of Previously Cleared/Predicate 510(k)s
  • Registering Mfg Establishment & Listing of Devices
  • Traditional Premarket Notification/PMN 510(k)s for Non-exempt Class 2 and Class 1 IVD Medical Devices
  • Special 510(k) and Abbreviated 510(k) without changes to previous Indications for Use
  • Relationship to Eventual & Direct FDA Inspection to "Design Control" Components of FDA’s Reqired "Quality System Regulations" [i.e., especially to Indications for Use and IVD Device Labeling]
  • "De Novo" IVD Submissions [i.e., NO Direct Predicate] Require Premarket Approval /PMA, a more Lenthy Process
Areas Covered in the seminar:
  • IVD Validation & Clearance [as described above]
  • Why IVDF validation makes good business sense
  • The top 10 errors in IVD device validation
  • What procedures are required and where to get them
  • What approaches you can use: prospective, concurrent, and retrospective
  • How to validate new systems with a prospective validation process
  • How to validate existing systems using a combination of concurrent and retrospective validation
  • What are the minimum deliverables that I must create

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • End-users responsible for applications that need to be validated re: IVD devices
  • QA managers and personnel
  • IVD & Biotechnology managers and personnel
  • IVD & Biotechnology Validation specialists
  • IVD Consultants
  • IVD Quality System auditors

Instructor Profile:

Alfredo J Quattrone, Ph.D., is a Senior Compliance Scientist with Auk Technical Services, Inc. (ATS), a California-based consulting firm that specializes in quality systems for IVD device & biomedical drug companies, especially review & validation of in vitro diagnostics /IVD firms. Dr. Quattrone previously served as a Third Party Reviewer for FDA and over the last 6+ years successfully reviewed 35+ PMN submissions for 510(k) clearance through Dec. 2006, when he retired from CA State service. Dr. Quattrone is also certifed in ISO 13485 inspections and has collaborated with Mr. Dennis Moore, CEO of ATS, in writing a detailed set of policy and procedural documents and templates for use by in vitro diagnostic, drug and biological/biomedical firms for systems validations, available via ATS, Inc.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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