How to Prepare for an FDA Inspection of Medical Devices
$279.00 – $2,550.00
In this course, the instructor will provide an “insider’s guide” of tips, examples and advice for specific areas where FDA inspectors will focus their inspection efforts related to the 31 sections of the 21 CFR Part 820 Quality System regulation.
Description
COURSE DESCRIPTION
OVERVIEW
Medical device inspections from FDA can be a nail-biting experience. However, with the right preparation and due-diligence, you can be prepared for any situation. In this course, the instructor will provide an “insider’s guide” of tips, examples and advice for specific areas where FDA inspectors will focus their inspection efforts related to the 31 sections of the 21 CFR Part 820 Quality System regulation.
- FDA’s approach to conducting inspections
- How FDA prioritizes their inspections
- 7 major & minor sub systems of QSIT
- Types of FDA inspections
- Which documents FDA cannot request
- “Back room” preparation for the inspection
- FDA 483s – Wording & Trends
WHO SHOULD ATTEND
This course will be of benefit to any manager in a medical device manufacturer of Class II or Class III medical devices. Quality Systems Experts are typically responsible for hosting and managing FDA inspections, but any department manager needs to understand the legal requirements of FDA inspections and to understand the strategy behind preparing for one.
WHAT TO EXPECT
HOW TO PARTICIPATE
This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.
THE TRAINING PLATFORM
Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.
USER AGREEMENT
Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.
Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.
Additional information
| Format | Recorded Only |
|---|---|
| Participants | Single Participant, 5 Participant Value Package, 10 Participant Value Package |
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