ComplianceOnline

US FDA Medical Device QSR, 21 CFR 820 and Quality Management System

Instructor: John E Lincoln
Product ID: 705794
Training Level: Basic to Intermediate
  • 12
  • September 2018
    Wednesday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 60 Min

Live Online Training
September 12, Wednesday 10:00 AM PDT | 01:00 PM EDT | Duration: 60 Min

$199.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$349.00
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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD/USB

$499.00

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Read Frequently Asked Questions

Learn the basic overview of the original medical device Quality Management System -- The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820. Implementation, training requirements and content, and annual internal audit / inspection expectations. The FDA’s four key areas of compliance under QSIT.

Why Should You Attend:

In the U. S., the Quality System (QS) Regulation (21 CFR Part 820) governs the manufacturing of medical devices, the device CGMPs. What is the importance, and purpose, and the framework of basic requirements for design and manufacture of medical devices, as well as a summary of the key requirements, the 15 subparts, terms, and the underlying purpose for the requirements under the Device CGMPs? How is a company’s quality management system “established / implemented and maintained under this Quality Management System (QMS)? Major discussion points: Regulatory requirements that apply to the methods, facilities and controls used for device design and development, production, installation, documentation, and servicing. Also: the Quality Management System, Management Responsibility, Managing Resources, Planning, Design and Development / Control, Change Control, Purchasing, Production, and Monitoring, Analysis, and Improvement.

Areas Covered in the Webinar:

  • What are US FDA expectations for a compliant device QSR?
  • How can a company develop and maintain a dual QMS.
  • Basic Systems / SOPs.
  • QSIT (FDA’s Quality System Inspection Technique)
  • Brief discussion of ISO 14971 (Device Risk Management) and IEC 62366-1 (Use Engineering / Human Factors) and where they fit.
  • Current areas of FDA concern.
  • Other US FDA device requirements.
  • Maintaining compliance under increasing regulatory expectations.
  • Similarities /differences to ISO 13485 and the MDR.

Who Will Benefit:

  • R&D
  • Engineers
  • Software developers
  • QA / RA
  • Marketing
  • Manufacturing
  • Operations
  • Staff
  • Middle Management
  • Senior Management
Instructor Profile:
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 36 years’ experience in U.S. FDA-regulated industries, 22 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.

Follow us :
IEC 60601-1 (3.1) The New Paradigm
Vendor and Supplier Qualification Program for FDA Regulated Industries

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.

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