Complaint Handling and Medical Device Reporting (MDR) are a part series
on Post Market Compliance for medical 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 or preventive actions.
Why you should attend
Customer satisfaction plays a significant role in measuring a
product’s postmarket performance. It is an indicator of how effective
the product performance is managed. Both the quality system regulation
(QSR) and the International Organization for Standardization (ISO)
require procedures and processes to monitor and control your post market
problems. The complaint-handling mechanism not only collects feedback
from unsatisfied customers, but also provides means for failure
investigations and subsequent corrective and preventive actions (CAPA).
Device Reporting (MDR) compliance involve regulatory obligations and
proper and timely reporting. Failure to properly report events can cause
costly problems for a manufacturer and can be life threating for
consumer. The number of device companies not submitting timely reporting
or accurately reviewing incoming complaints 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
This course will provide an understanding of MDR
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, Over 80% of FDA Inspections target observations for lack of
compliance in these areas.
Join Rita Hoffman, RAC an expert in
the field of Post-Market Compliance. Not only will you learn from her
over her 40 years in both FDA as a Compliance Officer and Ombudsman,
learning from her stories of what not to do, but you will take back a
desktop manual on Post-Market reference guide.
Areas Covered in the Session
- Understand how to comply with complicated Compliant Handling, MDR requirements
- Firms MDR reporting and FDA's handling of MDR reports
- Minimize your risk of regulatory enforcement actions
- Assist with the creation and maintenance of effective procedures for handling complaints, reportable events
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
Who Will Benefit
- Regulatory Affairs
- Project Managers
- Regulatory Professional
- Risk Managers
- Complaint Handling Teams
- CAPA Teams
- Complaint Handling and FDA Expectations
- Medical Device Reporting Procedures (MDR) Procedures and Regulations
- MDR reporting by firm, agents and exemptions
- Standard Operating Procedures
- Guidance Documents Update and eMDR Discussion
- What to expect from the Inspector
Rita Hoffman is the Principal Consultant/Owner of Regs & Recall Strategies, LLC, and 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. She enjoys teaching firms on how to think like and FDA Officer and shares her skills on her past experiences both in and out of FDA.
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, she has help to her 2-day seminars she has held a number of Webinars on Post-Market issues and emerging FDA Guidance.
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. 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.