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

Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

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.

**New course materials have been added, updated content will include:

• Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
• What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.

Learning Objectives:

• Understand how to comply with complicated Complaint Handling, MDR and Recall requirements
• Firms MDR reporting and FDA's handling of reports
• Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
• Minimize your risk of regulatory enforcement actions
• Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls
• Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
• Walk-through of case examples
• Step-By-Step guide to designing Standard Operating Systems for communicating process for firm's success
• Discussion of FDA's New Guidance's on Risk and how it interacts with Recalls

Who Will Benefit:

This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting.

• Regulatory Affairs
• QA/QC
• Project Managers
• Regulatory Professional
• Risk Managers
• Complaint Handling Teams
• CAPA Teams

Topic Background:

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.

This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes. 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.

In-Person Seminar going Virtual with increased learner satisfaction.

• Yes, attend this seminar from anywhere. We are making it real and more interactive - Here's a sneak peek:
• Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
• The real-time and live presentation as in in-person events
• Private chat for company-specific conversation - the same as you would get in an in-person seminar
• Opportunities to connect with your peers to share knowledge at a different time and have group discussions
• Live workshop activities
• Live Q&A during the event and offline Q&A assistance after the event
• As usual more content, activities and case studies and now adding homework for a comprehensive understanding
• Certification