Effective Complaint Handling, Medical Device Reporting and Recalls -- Avoiding Costly Errors: One and a Half-day In-person Seminar
Len Valenti, Senior Compliance Expert, Valtech LLC and Former FDA Compliance expert
Pittsburgh Marriott City Center, PA
| Thursday, May 8, 2014 | Friday, May 9, 2014
This interactive one and a half day course led by Len Valenti, Senior Compliance Expert at the FDA, who has more than three decades of experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions.
During the seminar, Mr. Valenti will explain 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. He will also discuss 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.
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.
Seminar instructor Len Valenti has more than three decades of experience working with the FDA. As an FDA team member, Len served as a chemist and a compliance officer in CDER, CFSAN, CDRH, ORA CVM and the Office of the Commissioner as a International Policy Analyst.
- 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.
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
- Project Managers
- Regulatory Professional
- Risk Managers
- Complaint Handling Teams
- CAPA Teams
|Conference Day One (8:30 AM – 5:00 PM)
||Conference Day Two (8:30 AM – 12:00 PM)
- Registration Process: 8:30 AM - 9:00 AM
- Session Start: 9:00 AM
- Introduction to class (20 min)
- Complaint Handling and FDA Expectations (70 min)
- What is a complaint?
- Firms Responsibilities and Definitions
- Complaint Forms
- FDA Expectations for written procedures on complaint files
- Medical Device Reporting Procedures (MDR) (60 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
- 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)
- Medical Products Safety Network (MedSun)
- User Error Malfunction
- Identifying a Malfunction
- Malfunction --To report or not to report
- Serious injury triggers
- Person Qualified Makes Medical Judgment
- Recalls: Definitions and Legal Authority (45 min)
- What is a recall?
- Legal Authority (Chapter 7, 21CFR 806)
- 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
- Examples of Close-calls
- Guidelines and best practices for having contingency plan in place
- 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
- 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
- Silent Recalls vs. Product Enhancements (20 min)
- Device changing environment
- 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
- 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)
Meet Your Instructor
Senior Compliance Expert, Valtech LLC and Former FDA Compliance expert
Len Valenti, is the owner of Valtech LLC, established in 2006 involved with FDA enforcement remediation. He has 30 years of FDA experience working for the U.S. Food and Drug Administration (FDA) in various capacities including both Centers and Field. As an FDA team member, Len served as a chemist and a compliance officer in CDER, CFSAN, CDRH, ORA CVM and the Office of the Commissioner as a International Policy Analyst. Using his strong compliance knowledge of GLPs, GMPs, QSR, HACCP, QSIT, ISO standards, and PIC/S (Pharmaceutical International Convention/scheme), he developed regulations and policies for drug safety, non-clinical laboratory testing, bio-terrorism, drugs, import procedures, global recalls, and medical device performance standards. Also, his regulatory policy knowledge includes labeling, listings, registration, ANDA submission requirements, and authorizing foreign clinical studies. Among his scientific background he authored Journal articles, reviewed ANDA’s submissions, evaluated 17025 laboratory accrediting bodies, Developed laboratory standards and responsible for adapting technology transfer to FDA. Mr. Valenti originated enforcement decisions on drugs, devices and veterinary products, and is an expert on pre-market and post-market importation.
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Pittsburgh Marriott City Center
112 Washington Place
Pittsburgh, Pennsylvania, 15219, USA
May 8-9, 2014
Special Offer for the attendees of this seminar:
Hotel rooms available at only $169 per night.
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You must book by Wednesday, 16th April, 2014 to receive the group rate.
Please note: Hotel rooms are limited and based on availability
How to Reach
General Driving Directions:
Driving Directions from Pittsburgh International Airport – PIT: 17 mile(s) SE
- Take I-376 E/US-22 E/US-30 E via Exit 6A Going through the Fort Pitt Tunnels and over the Fort Pitt Bridge
- Follow signs to I-376 East Monroeville
- Take the left hand exit, Grant Street, Exit 71A (stay on Grant Street) make a right on 6th Avenue
- Go two lights and make a left onto Centre Avenue
- Go to the first light and make a right onto Washington Place. Make the very next right into the Marriott.
- Greyhound Bus Lines: 0.5 mile(s) N
- Super Shuttle: 0.1 mile(s) E
- Steel Plaza: 0.2 mile(s) W
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