Training Course Syllabus:
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.
- 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