3-Days In-Person Seminar

Bad Things Happen, But It Can Get Worse - Understanding FDA Post Market Regulations

Rita Hoffman
San Francisco,CA
May 23 - May 25 , 2018

Starting at

$1999

Premier pro price: $1899 (save 5%)

May 23 - May 25 , 2018
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You can participate in an interactive course led by Ms. Rita Hoffman, former FDA CDRH Recall Branch Chief and Casper Uldriks, former Associate Director of CDRH. They will explain how participants can mitigate the risk of regulatory enforcement actions; avoid future recalls by using the Total Product Life Cycle TPLC paradigm that CDRH uses.

Discover how to overcome one of the biggest obstacles device manufacturers face, developing and implementing the proper handling of complaints, complaint filings under the Medical Device Reports (MDR) regulation and effective action with other state and federal public health and regulatory The seminar will cover how to conduct a correction and removal actions so you can void a recall crisis due to key factors that you face in real life experiences of FDA.

Course materials include creating Standard Operating Systems for Post-Market Quality Systems, how risk guidance document intertwines with Recalls and ORA Inspection Realignment Structure.

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that has only been offered by Casper Uldriks and Rita Hoffman, who bring over 68 years of combined experience.

Learning Objectives:

  • Learn about the FDA's agency-wide legal and procedural steps and investigational operations for post market issues
  • 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

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
  • QA/QC
  • Project Managers
  • Regulatory Professional
  • Risk Managers
  • Complaint Handling Teams
  • CAPA Teams

Topic Background:

Post Market compliance for a Medical Device firm are expensive, time consuming and can lead to serious financial consequences. 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 are critical to the continue survival of all 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 and removal actions. 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.

Recalls involve regulatory obligations, such as Post-Market regulations, complaint handling, Medical Device Reports, and a required report to the FDA under the Corrections and Removals regulation. Those are the easy issues to understand, in reality, it is much more complicated. Over 80% of FDA Inspections target observations for lack of compliance in these areas.

DAY 01(8:30 AM - 4:00 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction to class (20 min)
  • New ORA Alignment and Inspection Changes (30 min)
  • What to expect during Inspection (60 min)
  • Complaint Handling and FDA Expectations(90 min)
  • Medical Device Reporting Procedures (MDR) Procedures and Regulations (60 min)
  • MDR reporting by firm, agents and exemptions (30 min)
  • MDR FDA Perspective and MedSun (30 min)
  • User Error/Malfunction (30 min)
  • FDA’s Legal Basis for Recalls and Enforcement (30 min)
  • FDA’s Agency Wide Recall Investigation Procedure (60 min)
  • End of Day Close-out Discussion (15 min)
DAY 02(8:30 AM - 4:00 PM)
  • FDA's Agency-wide Standard Regulatory Procedures (60 min)
  • Recalls: Definitions and Legal Authority for CDRH (45 min)
  • Risk Based Guidance Documents Effecting Recalls (30 min)
  • Preparing Standard Operating Procedures(20 min)
  • Correction Action or Preventative Action Plan and Determining Root Cause Analysis (CAPA) (45 min)
  • Alternatives to Reports of Corrections and Removals (15 min)
  • Being Recall Ready - Proactive Steps to Avoid Management Crisis (45 min)
  • Evaluating Risk and Health Hazard Evaluation (HHE) (60 min)
  • Developing effective Strategies and Communicating with FDA Field Experts (90 min)
  • Silent Recalls vs. Product Enhancements(20 min)
  • Negotiating and Meeting with FDA(30 min)
  • End of Day Close-out Discussion (15 min)
DAY 03(8:30 AM - 4:00 PM)
  • Recap from Days 1 & 2 (30 min)
  • Device Software Cybersecurity (60 min)
  • Software enterprise systems and assignment of recall responsibility (15 min)
  • Notification Letters and Press Releases (45 min)
  • Product Retrieval Issues, Effectiveness Checks and Status Reports (50 min)
  • Termination of a Recall (15 min)
  • Recall Follow Up & Voluntary destruction (30 min)
  • Retrospective Assessment (15 min)
  • FDA Follow Up Planning (60 min)
  • FDA's Use of Recall Data (30 min)
  • Mock Recall and Wrap-up (35 min)
Seminar (Price/Register)
May 23 - May 25 , 2018 (3 Days) San Francisco,CA

Single Attendee

Premier pro price: $1899 (save 5%)

Special Group Discount Register for Six attendees

Premier pro price: $9499 (save 5%)

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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Speaker: Rita Hoffman,

Rita Hoffman is the principal consultant for 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, compliant handling, MDRs and recalls. Ms. Hoffman is regulatory certified by the Regulatory Professionals Society (RAPS) and holds a BS from the University of Maryland in addition to the many awards she has received from both government and industry.


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