2018 - Uncovering and Managing Successful Post Market Compliance for Medical Devices

Course "Uncovering and Managing Successful Post Market Compliance for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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).
Medical Device Reporting (MDR) and recall compliance involve regulatory obligations and proper and timely reporting. Failure to properly report events and take corrective and removal actions can cause costly problems for a manufacturer and can be life threating for consumer.. The number of device companies having their recall classified as a Class 1 (most severe) 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 required. This course will provide an understanding of MDR & recall 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, including recalls. 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.
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Areas Covered in the Session:
• Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
• Firms MDR reporting and FDA's handling of MDR 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
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Who will benefit:
• Regulatory Affairs
• QA/QC
• Project Managers
• Regulatory Professional
• Risk Managers
• Complaint Handling Teams
• CAPA Teams
Agenda:
Day 1 Schedule
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Lecture 1 (90 Mins):
• Complaint Handling and FDA Expectations
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Lecture 2 (90 Mins):
• Medical Device Reporting Procedures (MDR) Procedures and Regulations
• MDR reporting by firm, agents and exemptions
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Lecture 3 (90 Mins):
• Standard Operating Procedures,
• Guidance Documents Update and eMDR Discussion
• Ways FDA works with Counterparts
• What to expect from the Inspector
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Lecture 4 (90 Mins):
• Recalls, Definition and Legal Authority Overview
• Being Recall Ready
Day 2 Schedule
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Lecture 1 (90 Mins):
• Corrective and Provetive Actions
• Health Hazard Evaluations
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Lecture 2 (90 Mins):
• 806 Reporting
• Developing Effective Strategies and Communicating and Negotiating with FDA Notifications Letters and Press Releases
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Lecture 3 (90 Mins):
• Silent Recalls and Product Enhancements
• Product Retrieval, Status Reports
• Effectivness Checks
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Lecture 4 (90 Mins):
• Follow-up Planning
• Terminating a Recall
• Participating in a Mock Recall (Class Participation)
• Close out
Speaker
Rita Hoffman
Owner, Regs & Recall Strategies
Ms. 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.
Location: Philadelphia, PA Date: October 25th & 26th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153
Price:
Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)
Sponsorship Program benefits for seminar
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