How to host an FDA inspection and avoid 483's (based on practical experience)
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| Description: | DESCRIPTION FDA must inspect every class II or III medical device manufacturer every two years. This course will explain how to prepare for an inspection including assigning personnel to specific tasks during the audit, facility requirements to support the audit, the value of mock audits, how personnel should conduct themselves during the audit, how the inspection will unfold and how to respond to 483's Why should you attend : Understand the types of FDA inspections and be prepared for an inspection so as to minimize chancesof receiving observations (483's) Areas Covered in the Session: Types of FDA inspections; Inspection preparation including people required and dedicated facilities; Mock audits; Behaviour during an inspection-what to say, what not to say;how to respond to a 483; SOP for an inspection; Who will benefit: (Titles) Engineers, Company management, Quality personnel Webinar includes: Q/A Session with the Expert to ask your question PDF print only copy of PowerPoint slides 60 Minutes Live Presentation Certificate of attendance For Registration : http://c2gowebinars.com/product/?topic=how-to-host-an-fda-inspection-and-avoid-483 Note: Use coupon code <T9AIO8AY > and get 15% off on registration. |
| URL: | http://c2gowebinars.com/product/?topic=how-to-host-an-fda-inspection-and-avoid-483 |
| Date: | Wednesday, May 11, 2016 |
| Time: | 5:00pm-6:00pm UTC |
| Duration: | 1 hour |
| Access: | Public |
| Created by: | Public Access |
| Updated: | Wednesday, April 13, 2016 9:43am UTC |
| : | $179 |
| : | (877) 782-4696 |
| : | subscribe@compliance2go.com |
| : | David |
| : | 8777824696 |
| Comments: | None |