Recalls are expensive; that hurts profit. Recalls are time consuming time consuming; that diverts human resources that could be doing more productive operations. And, recalls can lead to unanticipated regulatory outcomes, which adds a degree of ‘fear and trembling’ concerning FDA’s follow up. Recalls involve regulatory obligations, such as complaint handling, adverse event reports and even mandatory recalls for devices and food products. Some recalls present an unacceptable probability of substantial harm or death. Those are the easy issues to understand. Those situations can lead to a reallocation of FDA resources and intense scrutiny. On the lighter side, some recalls end up causing some amusing situations for the FDA investigator. Recalls reflect the adequacy of a firm’s quality assurance operations and its corrective and preventive action program (CAPA.) Over 80% of FDA Inspections cite these deficiencies for a for lack of compliance in these areas.
You can participate in an interactive course led by Ms. Rita Hoffman, fFormer FDA CDRH Recall Branch Chief and Casper Uldriks, former Associate Director of CDRH. They will explain how participants can prepare for recalls before they happen, how to evaluate problems that may or may not prompt a recall, and how to manage a recall. They bring a total of 32 years of FDA experience and ideas about how to build a workable recall program. You can save time and money that way.
Conformance with FDA manufacturing regulations for any product has inevitably been inadequate, if not lacking. FDA often inspects firms that have multiple recalls or those with a high risk to health. FDA investigators know how to quickly focus their regulatory evaluation. Sometimes managing the FDA becomes an issue that is as difficult to manage as the recalled product itself. Understanding, developing adequate procedures for applicable regulatory manufacturing regulations and effectively implementing recall procedures can take some of the anxiety out of a recall situation. Perhaps it might lower the probability that FDA will pay you an untimely visit
The recall seminar includes two major components: 1) recall management that applies to all FDA regulated products, and 2) a thorough presentation about medical device recalls that will focus on postmarket regulations for reporting, CAPA, total product life cycle (TPLC) and how the European Union’s Medical Device Regulation (MDR) impacts postmarket management of adverse events and recalls. The EU’s MDR is being implemented now and includes a demanding program on a firm’s part. This will be particularly important for global medical device manufactures.
**New course materials haves been added, such as creating Standard Operating Systems 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 has only been offered by Rita Hoffman and Casper Uldriks, who bring over 68 years of combined experience.
Learning Objectives:
- Learn about the FDA’s agency-wide legal and procedural steps and investigational operations for recalls
- Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
- Firms MDR reporting and FDA's handling of MDR 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) 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.
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Introduction to class (20 min)
- Agency-wide recall program and procedures (60 min)
- Scope of Recalls – Products, People and Places
- Domestic vs. Domestic Import Recall
- Recall Exemptions
- Recall Rebuttable Presumptions
- Recall criteria in Law and in Fact
- Park Doctrine - Accountability
- FDA’s Agency-wide Standard Recall Regulatory Procedures (60 min)
- FDA’s Agency-wide Recall Investigation Procedures (60 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
- Preparing Standard Operation Programs (30 min)
- 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
- Negotiating and Meeting with FDA (30 min)
- Device Software Cybersecurity (60 min)
- Alternatives to Reports of Corrections and Removals (15 min)
- Software enterprise systems and assignment of recall responsibility (15 min)
- 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
- New ORA Alignment and Inspection Changes (30 min)
- 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
- Recall Follow Up (30 min)
- Voluntary destruction of recalled product
- Retrospective Assessment
- FDA Follow Up Planning (60 min)
- FDA’s Use of Recall Data (30 min)
- Mock Recall and Wrap-up (30 min)
- Recap from Days 1 & 2 (30 min)
- Device Software Cybersecurity (60 min)
- Software enterprise systems and assignment of recall responsibility (15 min)
- Notification Letters and Press Releases (45 min)
- Product Retrieval Issues, Effectiveness Checks and Status Reports (50 min)
- Termination of a Recall (15 min)
- Recall Follow Up & Voluntary destruction (30 min)
- Retrospective Assessment (15 min)
- FDA Follow Up Planning (60 min)
- FDA's Use of Recall Data (30 min)
- Mock Recall and Wrap-up (35 min)
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.
Casper (Cap) Uldriks,
Former Associate Center Director of FDA's CDRH
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.
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