This course on Medical Device Complaint Handling Training aims at providing a close understanding of MDR & recall compliance. It also deals in handling the interrelationship of Complaint Handling, CAPA, and Risk Administration procedures.
Post-Market activities, Grievance Handling, MDRs, and Recalls are luxurious, time-consuming, and often lead to graver monetary penalties. Over 80% of FDA Inspection target observations for lack of compliance in these areas.
By attending this seminar, every trainee will be able to find out and discover:
- Different ways to overcome one of the major hindrances device manufacturers encounters
- How the FDA expects you to grow and device proper handling of complaints reportable or non-reportable, product complaint management and certification
- How and when to file Medical Device Reports (MDR), actual and suitable message with the apt controlling agencies in the event of a recall.
- How to demeanor improvement and elimination actions to avoid a recall emergency, including required recordkeeping, anticipation from FDA and other monitoring agencies in the event of a recall, and crucial factors in applying and upholding compliance with the regulations and real-life experiences of FDA.
**New course materials have been added, and updated content now contains:
- 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 on Medical Device Reporting Training will have you stop spinning your wheels with supplementary actions, and leave you with a complete knowledge set that only WCS can provide.Who are the possible beneficiaries of this course in Medical Device Reporting Training?
Objectives of Learning- Medical Device Reporting Training
- Knowledge of ways to comply with complex Complaint Handling, MDR, and Recall requirements
- Companies' MDR reporting and FDA's management of reports
- Company training in the event of a Recall, recall policy, notification letter, and interactive with the FDA
- Diminish the risk of controlling implementation activities
- Contribution to the creation and maintenance of real events for treatment complaints, reportable events, and recalls
- Comprehend the relationship and interaction with other quality system elements as they relate to complaints and reportable events
- Walk-through of case instances
- A step-by-step guide to designing Standard Operating Systems for communicating processes for the success of the firm
- Discussion of FDA’s New Guidance on Risk and how it interacts with Recalls
Course Content
Introduction (15 mins)
Course Provider
Ms Rita Hoffman,
Managing Partner Regs & Recall Strategies ,
Compliance OnlineRita Hoffman, RAC. Managing Partner Regs & Recall Strategies, LLC .Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries. She has an intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an FDA compliance consultant, she provides clients with regulatory insight, advises on critical compliance deficiencies, performs compliance and new product audits, provides insight and guidance on recall strategies to the medical device industry, and advises on jurisdiction determinations for combination products.
Ms. Hoffman retired from the FDA in January 2011 as the Recall Branch Chief for the Center for Devices and Radiological Health (CDRH), where she was responsible for oversight and review for all medical device recalls. Ms. Hoffman held several positions including the Center for Drug Evaluation and Research (CDER) Jurisdiction Review Officer (providing guidance on drug/device product designation, combination products and co-packaging), Acting Associate Ombudsman, Small Business Liaison, and was a Policy Analyst for eight years in the Office of the Commissioner. She served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, and in 2008 was presented with the Special Recognition Award by RAPS.
Who Should Attend
- CAPA Teams
- Quality Assurance
- Regulatory Affairs
- Risk Management Professionals
- Quality Control
- Project Managers
- Regulatory Professional
- Complaint Handling Teams
