Presented by Rita Hoffman
Wednesday, November 8, 2017; 1:00pm – 2:30pm EST (GMT -5)
The numbers make it clear. Medical device firms face challenges in understanding the scope and proper procedures needed to develop a compliant complaint handling process. In 2016 alone, over one-third of FDA’s Medical Device Warning Letters cited firms for errors in complaint handling procedures…problems cited covered reviewing, receiving, and evaluating complaints in addition to flawed management programs and procedures.
If you are a manufacturer (or a Designated Agent for firms outside the US) of any class of medical device you are NEVER exempted from the Quality System Regulation complaint handling requirements or general record requirements…and you must be prepared to have your complaints reviewed by FDA investigators.
On November 8, 2017, join FOI Services as Rita Hoffman, formerly CDRH’s Recall Branch Chief, offers a 90-minute, audio-format, presentation outlining FDA’s current Medical Device Complaint Handling Procedures…as well as how to review and process them for next steps in post-market evaluations. You will come away with a broad understanding of steps to track and trend overview of complaint process and common mistakes and potential consequences of non-compliance during review.
What You'll Learn:
- Up-to-date information to help you understand the meaning of a complaint
- Identify poor performance in the overall quality system
- Aid in implementing solutions to quality problems
- Verify confidence in and improve your complaint handling unit
- When a complaint turns into medical device reporting (MDR)
- Reduce employee confusion
- Improve customer relations by reducing the frequency of problems, complaints, and results
- Assure compliance with device regulations and consensus standards
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
- Project Managers
- Regulatory Professional
- Risk Managers
- Complaint Handling Teams
- CAPA Teams
About Your Instructor:
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 6 years.
Prior to working as a consultant, Ms. Hoffman spent more than 37 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 and compliance 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. In addition to her 2-day seminars she has held a number of Webinars on Post-Market issues and emerging FDA Guidances.
Ms. Hoffman, in addition to being 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. Ms. 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 and Outstanding Service Awards for her Compliance work and industry contributions.
If you have any questions about the content or coverage of this presentation, please email Ms. Hoffman directly at firstname.lastname@example.org.
In your office, conference room – or anywhere else you are!
Wednesday, November 8, 2017; 1:00pm to 2:30pm EST (GMT -5)
You can register for any of these options below. If you have questions or prefer to register by phone, call us at +1-301-975-9400.
Standard Order...Listen Live!
Your first toll-free (even if international) dial-in is $449 and covers one telephone connection – put the teleconference on your speakerphone and let everyone present listen for one price!
FOI Services will provide handouts and dial-in information for each connection ordered 1-2 business days before the teleconference.
Add extra connections to your Standard Order for only $89/line! Now you can affordably let colleagues in scattered offices, at home, on the road, or anywhere else listen live, too! When you place your Standard Order for a teleconference at the regular $449 price, you now have the option of adding more lines to the same invoice for only $89 per connection – just follow the directions online or call us at +1-301-975-9400! (Note: To qualify for this discount, extra lines must be ordered at the same time as a Standard Order.)
Can’t attend? Try the Audio Package for $449. The package includes online delivery of an mp3 file of the entire presentation, including the question and answer session, as well as all of the handouts. (Please allow one week after the event date for delivery.)
Listen Live..AND get a 50% discount on the Audio Package! If you order a live registration and the Audio Package for the same teleconference, you’ll receive a 50% discount on the audio. To order both the live registration and the audio package, register below, and you will be given an opportunity to add the audio as well. Or if you prefer, you can always phone FOI at 1-800-654-1147 (outside the U.S. and Canada call +1-301-975-9400).