ComplianceOnline

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 a 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.
Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions.

**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 Compliant 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
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 5:00 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction to class (20 min)
  • Complaint Handling and FDA Expectations (120 min)
    • What is a complaint?
    • How do you distinguish among a product complain, a satisfaction complaint and a customer inquiry.
    • Firms Responsibilities and Definitions
    • Should companies document all service call complaints
    • Complaint Forms
    • FDA Expectations for written procedures on complaint files
  • Medical Device Reporting Procedures (MDR) (90 min)
    • Understand the MDR regulation 21CFR 803
    • Definitions 21 CFR 803.3
    • MDR Procedures 21 CFR 803.17
    • Types of MDR reports
    • MDR reporting by firm, agents and exemptions
    • Who should maintain files, how long should files be maintained
    • Final regulations on eMDRs
    • Identifying a Malfunction
    • Malfunction --To report or not to report
    • Serious injury triggers
    • Person Qualified Makes Medical Judgment
  • MDR FDA Perspective (30 min)
    • CDRH Mandatory vs. Voluntary Reporting
    • What happens to an MDR report submitted to FDA
    • Manufacturer and User Facility Device Experience (MAUDE) and new data system being implemented
    • Medical Products Safety Network (MedSun)
    • UDI requirements
  • eMDR (20 min)
    • Brief overview of eMDR (20 min)
    • Understanding Timelines for Reporting
    • Problems with eMDR
  • New Guidance Documents for Postmarket Regulations (30 min)
    • Case for Quality
    • Changes in Traditional Compliance Requirements
    • Emerging Signals
    • Scope of Evolving Guidance Documents
    • Benefit Risk Assessments
    • Notable Changes in FDA Thinking
  • Recalls: Definitions and Legal Authority (45 min)
    • What is a recall?
    • Legal Authority (Chapter 7, 21CFR 806)
    • What are the key elements of 21CFR 806
    • What information needs to be reported and when?
    • Voluntary vs. Mandatory recalls
    • Definitions – Corrections, Removals
    • Reporting requirements for non-recall field actions
    • Classification system – Classifying a Recall?
    • What is different about Class 1 recall
  • Being Recall Ready –Proactive Steps to Avoid Crisis (45 min)
    • Internal Decision Making
    • Early warning signs
    • Assembling “The Team” – Assigning decision making authority
    • Elements of an effective recall team
    • Responsibilities of other departments
    • Examples of Close-calls
    • Guidelines and best practices for having contingency plan in place
Day 02(8:30 AM - 4:00 PM)
  • Evaluating Risk and Health Hazard Evaluation (HHE) (60 min)
    • Analyzing adverse event and product quality reports
    • Identifying trends, Data and factors to consider
    • Assessing need to conduct HHE
    • HHE Procedures
    • Human Factors Issues
    • Opening a CAPA to Determine Root Cause and relationship to CAPA System
  • Elements of a Correction and Removal Report (806.10) (90 min)
    • Designing an 806 Report
    • Communicating with FDA
    • e 806 reporting
    • Expanding a C & R Report
    • Records/Exemptions
  • Developing Effective Strategies and Communicating with FDA (80 min)
    • Elements of a good Recall Strategy
    • What does the FDA expect strategy to contain?
    • Effective Notification Letter to minimize consequences
    • Knowing when to contact FDA District
    • Discussing Recall Strategy with FDA – Seeking input and support of your strategy to avoid common pitfalls
    • Issuance of Press Release and communication with customers
  • Notification Letters and Press Release (45 min)
    • Terminating a Recall
    • How and when does termination take place?
    • Communication between the firm and the District Office.
    • Requesting a formal recall closeout.
    • CAPA and finding the root cause (overview only)
  • Silent Recalls vs. Product Enhancements (30 min)
    • Device changing environment
    • Guidance Document and expectations
    • Product improvement (Repair or Modification)
    • Decision 803 or 806
  • Product Retrieval Issues, Effectiveness Checks and Status Reports (50 min)
    • Receiving and accounting for returned products
    • Supply chain challenges – distribution, wholesale, repackaging
    • Global recall market
    • Designing an efficient Effectiveness Checks
    • Coordination and Discussion with FDA
    • Evaluating recall effectiveness Data
    • Developing and formatting status reports
  • Changes in Inspections, Look-back from Recalls and Other Field Actions (30min)
    • What are the consequences of a recall?
    • How do you prepare for a post recall inspection
    • What customers and other outside communication are necessary?
    • What factors should you consider when determining whether or not to get your product back?
    • What to expect during inspection
    • How FDA has changes inspection (Who, What, How)
  • Termination of a Recall (15 min)
    • Who, how and when does termination happen
    • Exporting a Recalled Product
    • Communication between firm and District Office
    • Requesting formal closeout by FDA
  • Mock Recall and Wrap-up (35 min)
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Rita Hoffman

Rita Hoffman, RAC,
Managing Partner Regs & Recall Strategies, LLC and Former FDA CDRH Recall Branch Chief

Rita Hoffman, RAC. Managing Partner Regs & Recall Strategies, LLC .Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries. She has an intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an FDA compliance consultant, she provides clients with regulatory insight, advises on critical compliance deficiencies, performs compliance and new product audits, provides insight and guidance on recall strategies to the medical device industry, and advises on jurisdiction determinations for combination products.

Ms. Hoffman retired from the FDA in January 2011 as the Recall Branch Chief for the Center for Devices and Radiological Health (CDRH), where she was responsible for oversight and review for all medical device recalls. Ms. Hoffman held several positions including the Center for Drug Evaluation and Research (CDER) Jurisdiction Review Officer (providing guidance on drug/device product designation, combination products and co-packaging), Acting Associate Ombudsman, Small Business Liaison, and was a Policy Analyst for eight years in the Office of the Commissioner. She served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, and in 2008 was presented with the Special Recognition Award by RAPS.

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$1,299.00

Seminar One Registration

May 16-17, 2019, Newark, NJ




The registration fee includes: the workshop; all related course materials; morning tea/coffee with cookies on Day 1; lunch on Day 1; afternoon tea/coffee on Day 1; and morning tea/coffee on Day 2.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

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Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

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After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

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Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location :

    Newark, NJ
    (Venue to be announced shortly)

    May 16-17, 2019

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    Local Attractions of Newark, NJ

    Newark Museum:

    Newark Museum:

    The Newark Museum, in Newark, Essex County, is the state's largest museum. It holds fine collections of American art, decorative arts, contemporary art, and art from Asia, Africa, the Americas, and the ancient world. Its extensive collections of American art include works by Hiram Powers, Thomas Cole, John Singer Sargent, Albert Bierstadt, Frederick Church, Childe Hassam, Mary Cassatt, Edward Hopper, Georgia O'Keeffe, Joseph Stella, Tony Smith and Frank Stella. The Newark Museum's Tibetan galleries are considered among the best in the world. The collection was purchased from Christian missionaries in the early twentieth century.

    Prudential Center

    Prudential Center:

    Prudential Center is a multi-purpose indoor arena in the central business district of Newark. Opened in 2007, it is the home of the National Hockey League's (NHL) New Jersey Devils and the NCAA's Seton Hall Pirates men's basketball team. The arena seats 16,592 patrons for hockey and 18,711 for basketball. Fans and sports writers have affectionately nicknamed the arena "The Rock" in reference to the Rock of Gibraltar, the corporate logo of Prudential Financial, a financial institution that owns the naming rights to the arena and is headquartered within walking distance. In December 2013, the arena ranked third nationally and ninth internationally for self-reported annual revenue. It is located two blocks from Newark Penn Station in downtown Newark, just west of Newark's Ironbound district, making it easily accessible via New Jersey Transit, PATH, Newark Light Rail, and Amtrak.

    Branch Brook Park

    Branch Brook Park:

    Branch Brook Park is a county park of Essex County, located in the North Ward of Newark, between the neighborhoods of Forest Hill and Roseville. A portion of the park is also located within the Township of Belleville. At 360 acres, Branch Brook Park is the largest public park in the city of Newark. The park is noted for the largest collection of cherry blossom trees in the United States, with over 4,300 in more than fourteen different varieties collectively called Cherryblossomland, as well as its spectacular Cherry Blossom Festival each April. The festival attracts approximately 10,000 visitors each April. During World War II, the park's grounds served a tent city for recruits, as well as a landing strip for airplanes of the United States Postal Service. To the park’s east is the Cathedral of the Sacred Heart Basilica, one of the largest cathedrals in the United States.

    Cathedral Basilica of the Sacred Heart

    Cathedral Basilica of the Sacred Heart, Newark, New Jersey:

    The Cathedral Basilica of the Sacred Heart, the fifth-largest cathedral in North America, is the seat of the Roman Catholic Archdiocese of Newark. It is located at 89 Ridge Street in the Lower Broadway neighborhood of Newark, New Jersey. Envisioned as a fitting monument to the faith, construction began in 1899 and was finished in 1954. The original design called for an English/Irish-gothic church, but plans were later modified in favor of a French-gothic style. The Cathedral Basilica holds concerts open to the public throughout the year and it has the largest pipe organ ever built by the Schantz Organ Co. which includes 154 ranks playable from two consoles.

    Newark Symphony Hall

    Newark Symphony Hall:

    Newark Symphony Hall at 1020 Broad Street in Newark, Essex County, New Jersey, was built in 1925 and added to the National Register of Historic Places in 1977. Originally built by the Shriners at a cost of more than $2 million as Salaam Temple and colloquially known as The Mosque, the four-story building has been Newark Symphony Hall since 1964. The interior features Greek and Egyptian motifs, marble columns, a crystal chandelier, gold-leaf fret work and two-columned side promenades. The neo-classical building was design by Frank Grad, a prominent Newark architect, whose work includes the Lefcourt Newark Building and many others downtown. The 3,500-seat main concert hall is named for Sarah Vaughan, a native Newarker, and is renowned for its acoustics.

    Military Park

    Military Park:

    Military Park is a 6-acre city park in downtown Newark. It is a nearly triangular park located between Park Place, Rector Street and Broad Street. From 1667, when the city was planned, until 1869 it was a training ground for soldiers. In 1869, it became the town commons. The New Jersey Historical Society, Military Park Building and the New Jersey Performing Arts Center are located across Park Place from the park. A $3.25 million renovation was announced in February 2012 and the park reopened in June 2014.

    John Ballantine House

    John Ballantine House:

    The John Ballantine House was the home of Jeannette Boyd (1838–1919) and John Holme Ballantine (1834–1895). John was the son of Peter Ballantine, founder of the Ballantine beer brewery, and became president of the family business in 1883 after his father died. The house was built in 1885 at 49 Washington Street in the Washington Park section of Newark, Essex County, New Jersey. It is now part of the Newark Museum and is open to the public for tours.

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