DUBLIN, Mar. 21, 2017 /PRNewswire/ --
Research and Markets has announced the addition of the "Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits: One and a Half-day In-Person Seminar by Ex-FDA Official" conference to their offering.
This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years' experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions.
During the seminar, Ms. Hoffman 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. She 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.
New to Course will be creating Standard Operating Systems for Post-Market Quality Systems.
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.
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
Agenda:
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 (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
Day 02 (8:30 AM - 12:00 PM)
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)
Speakers:
Ms Rita Hoffman,
Managing Partner Regs & Recall Strategies,
Compliance Online
For more information about this conference visit http://www.researchandmarkets.com/research/44stv9/navigating_the
About Research and Markets
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