2-Day Virtual Seminar Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents

Rita Hoffman
Apr 29 - Apr 30 , 2021
Starting at

$1699


Apr 29 - Apr 30 , 2021
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Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

  • How to overcome one of the biggest obstacles device manufacturers face
  • How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
  • How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
  • How to conduct correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

**New course materials have been added, updated content will include:

  • Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
  • What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.

Learning Objectives:

  • Understand how to comply with complicated Complaint Handling, MDR and Recall requirements
  • Firms MDR reporting and FDA's handling of 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:

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) recall 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.

DAY 01(10:00 AM - 4:00 PM EDT)
  • Introduction (15 mins)
  • Session 1
    • Complaint Handling and FDA Expectations (90 mins)
  • Break (15 mins)
  • Session 2
    • Continuation Complaint Handling and FDA Expectations (30 mins)
    • Medical Device Reporting Procedures (MDR) Regulations, Procedures, and Malfunctions (60 min)
  • Lunch Break (45 mins)
  • Session 3
    • Continuation of Medical Device Reporting Procedures (MDR) Regulations, Procedures, and Malfunctions (60 min)
    • MDR reporting by firm, agents Voluntary Malfunction Summary Reporting (VMSR) and eMDR Discussion (30 min)
  • Break (15 mins)
  • Session 4
    • Guidance Documents Update (30mins)
    • Being Recall Ready (30mins)
    • Questions and Recap (10 mins)
DAY 02(10:00 AM - 4:00 PM EDT)
  • Session 1
    • Recalls, Definition and Legal Authority Overview (60 mins)
    • Corrective and Preventative Actions (CAPA) (30 mins)
  • Break (15 mins)
  • Session 2
    • Health Hazard Evaluations HHE/HRA (30 mins)
    • Elements of a Correction and Removal -- 806 Reporting (45 mins)
  • Lunch Break (45 mins)
  • Session 3
    • Developing Effective Strategies / Communicating and Negotiating with FDA (45mins)
    • Notifications Letters and Press Releases (20 mins)
    • Silent Recalls / Product Enhancements and Enforcement Actions (20 mins)
  • Break (10 mins)
  • Session 4
    • Product Retrieval (20 mins)
    • Status Reports (20 mins)
    • Effectiveness Checks Follow-up Planning (20 mins)
    • Terminating a Recall (15 mins)
    • Wrap-up (5 mins)
Seminar (Price/Register)
Apr 29 - Apr 30 , 2021

Single Registration


Group-Max. 10 Attendees


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

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  2. Fill this form with attendee details & payment details
  3. Fax your PO to 1-888-883-7697 or,
  4. Email it to cs@compliance.world

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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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