PRE-REGISTRATION AVAILABLE If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you. Pre-Register now and pay only once the training is scheduled on your preferred days. Click on the button below to pre-register
If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you.
Pre-Register now and pay only once the training is scheduled on your preferred days.
Medical Device Reporting (MDR) and recall compliance are critical to the continue survival of all device manufacturers. The FDA is continuing their efforts to issue numerous FDA Warning Letters and serious enforcement actions, including criminal & civil penalties levied on companies that failed to properly report events and take proper corrective and removal actions. The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Additionally, product liability and financial risks are staggering when companies fail to properly report and take action when required.
It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in medical device reporting (MDR) and correction & removal processes, including recalls.
This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes.
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:
|SEMINAR OBJECTIVES||WHO SHOULD ATTEND|
DAY 1 (10 AM to 3 PM)
DAY 2 (10 AM to 3 PM)
COURSE DIRECTOR: KELLY THOMAS
|Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.|
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.