DUBLIN–(BUSINESS WIRE)–The “Managing Your Complaints and Obstacles in Post-Market Requirements – Results from Top Medical Device Observations During an Inspection” conference has been added to ResearchAndMarkets.com’s offering.
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.
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 Should Attend:
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 1
Registration
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 2
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)
For more information about this conference visit https://www.researchandmarkets.com/r/hq8q9n
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
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