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Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic – Learn what FDA is really thinking on regulation and guidance documents

February 18 @ 10:00 am - February 19 @ 4:00 pm UTC-5

Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

  • How to overcome one of the biggest obstacles device manufacturers face
  • How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
  • How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
  • How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

Organizer

Compliance Online
Phone:
+1-888-717-2436
Email:
referral@complianceonline.com
Website:
https://www.complianceonline.com/

Venue

Online Event
Ijona Skills,364 E Main Street, Suite 1009
Middletown, DE 19709 United States
+ Google Map
Phone:
3028303132
Website:
https://www.ijonaskills.us/webinarDetails?webinarid=659&speakerid=45&domain=4&source=CC_LN