The New Medical Device Reporting (MDR) Guidance – An Easily Digestible Compliance Breakdown

Date: February 27, 2017
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!

Course Description:

With the release of the finalized Medical Device Reporting (MDR) guidance on November 8, 2016, FDA has taken several positions that are in direct contrast to their previous opinions on the subject.   Firms face new scrutiny from FDA on their complaint handling and reporting efforts.  The document itself is not an easy read, with 50+ pages of material outlining new positions that manufacturers consider when providing reporting obligations.  Even the most seasoned professionals will have a difficult time deciphering what’s different, what’s important, and what isn’t.  Thankfully, we have a 90-minute interactive webinar that will simplify the guidance and give you the tools to remain compliant or build top-notch compliance protocols.

During this webinar, you will be provided with bonus handouts and the opportunity to ask questions of an expert instructor.  Additionally, you will learn:

  • Overview of Medical Device Reporting and Complaint Handling requirements
  • A breakdown of the changes from the draft to final guidance – what you must know, what is presumed, and changes in reporting timeframes
  • Best practices to assess your current MDR efforts and implement changes to match the new guidance recommendations
  • Strategies for continuous improvement
  • What “Becoming Aware” really means – Ensuring your risks are mitigated
  • Outside US Occurrence: Steps to handle unique reporting requirements
  • Investigational Study Reporting

This course will be valuable to anyone involved in medical device complaint handling and MDR reporting, including everyone from phone teams, engineers, quality and compliance personnel, regulatory affairs, and upper management.

Rita Hoffman is the Principal Consultant/Owner of Regs & Recall Strategies, LLC, a consulting firm providing regulatory insight focusing on industry assistance on FDA compliance issues.  Ms. Hoffman has been consulting with FDA firms on post marketing issues for the past 4 years.

Prior to working as a consultant, Ms. Hoffman spent more than 36 years with the FDA. She retired in 2011 after holding the position of recall branch chief for the Center for Devices and Radiological Health (CDRH). She was responsible for oversight and review of all medical devices recalls with extensive knowledge of the legal authority of 21 CFR Parts 7 & 806, 803 and 820 of the Act. During Ms. Hoffman’s tenure with FDA, she served in several critical headquarter positions including: compliance officer, ombudsman, jurisdictional review officer, small business liaison, and policy analyst.

Ms. Hoffman has a diversified knowledge encompassing FDA scientific, investigational and regulatory policy areas due to her in-depth understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. Throughout her FDA career, she has provided guidance and clarified FDA requirements, to industry, foreign governments, public entities and FDA field personnel involving recalls, labeling issues, dietary supplements, pharmaceuticals, OTC drug products and combination products.

Ms. Hoffman continues to collaborate with industry as an expert advisor and remediates on regulatory subject matters including drug/device for recalls, GMP and quality systems inspections/regulations, field safety alerts for drug products, MDR and complaint handling, and other matters. She has been hosting trainings with various FDA Regulatory Groups for over 4 years on, complaint handling, MDRs and recalls.

Ms. Hoffman, in addition to RAPS Certified, is the recipient of RAPS Special Recognition Award for her unique contributions and achievements of individuals and organizations that advance the quality of health and regulatory affairs.  She served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, working in collaboration with both chapter members and FDA to increase professional awareness of regulatory issues.  Mrs. Hoffman holds a BS from the University of Maryland and has received many additional awards from both government and industry including the FDA Distinguished Government Service Award.