2 Days workshop Effective Compliance Strategies for Complaint Handling, Medical Device Reporting and Recalls

By: David R. Dills, Director of Regulatory Services at CROMSOURCE.
Product code: SEM54
Location 1: Philadelphia Mar 28 - 29


Course “Effective Compliance Strategies for Complaint Handling, Medical Device Reporting and Recalls" has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"

•       Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system
•       Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls
•       All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints
•       Provide information about FDA’s Medical Device Reporting (MDR) regulation and the Voluntary Reporting program called MedWatch
•       Introduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities 
•       Latest Amendments to the MDR Regulation to Implement FDAMA Changes
•       To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required
•       Determine when a recall is required and how to manage a recall, who must report, when to report, what to report, where to report, recordkeeping requirements, FDA regulatory authority,              references and guidance
•       Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
•       Review and discuss pain points, challenges and solutions

Areas Covered

•       Reporting complaints
•       Complaint evaluation and investigation and effective root cause analysis
•       Data collection and trending
•       CAPA process for investigating complaints
•       Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next
•       Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators
•       Improve communication and teamwork on complaints across departments and functional areas
•       Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process
•       Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints
•       Understand the History of MDR Regulation
•       What types of Reports does the FDA receive and who must submit Mandatory Reports to the FDA?
•       Who can submit Voluntary Reports to the FDA? 
•       How to submit e-MDR reports and ensure timely reporting requirements are met for MedWatch 3500A
•       How Does the FDA Use Medical Device Reports?
•       What are the exemptions, variances, or alternative forms of adverse event reporting requirements?
•       Basics of a Recall: Initiation, Classification and Public Warning
•       Medical Device Recall Reporting and Classification Levels
•       Recall Responsibilities & Requirements
•       FDA’s Role
•       Introduction to Medical Device Recalls: Industry Responsibilities

Who will Benefit

This seminar will provide an overview and in-depth snapshot of the process for managing your product complaint/complaint handling program, Medical Device Reporting program and addressing and facilitating Recalls. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the complaint handling, MDR and recall process from start to finish, including:

•           Regulatory Affairs Management
•           Regulatory Affairs Specialist
•           Auditors
•           Compliance Officer
•           Compliance Specialist
•           Clinical Affairs
•           Quality Assurance Management
•           Marketing & Sales 
•           Distributors/Authorized Representatives
•           Legal Counsel
•           Engineering/Technical Services
•           Operations/Manufacturing
•           Consultants

Learning Objectives

Pharma , Medical Device & Biotech

Course Outline:

(8:30 AM – 4:30 PM)

Day 1 Schedule

Lecture 1:

Complaint Handling

•           What are the elements of an effective complaint management
•           system?
•           How does risk management influence complaint handling
•           decisions?
•           What are the responsibilities of other departments?
•           What is the best way to train customer contact employees?
•           What steps would the FDA expect to see the departments taking that                    sorts out potential MDRs, product complaints and other reportable                          events?
•           What and how do you perform trending?
•           What are examples of how companies trend and analyze service calls                  and product complaints?
•           Understand how and why CAPA is tied in to product complaint                                 investigation
•           What is an appropriate complaint handling system in a risk-based post-                market environment?
•           How do you audit a complaint handling system?
•           From your audits, how do you judge that your complaint handling system               is effective?
•           Assignment of responsibility
•           Manufacturer should develop a method for maintaining records of                          complaints and investigations that: is functional and economical, meets                  company needs, and meets FDA requirements and expectations
•           Identify designated complaint handling unit
•           Instructions for documenting complaint information
•           Process for evaluating complaints
•           Process for investigating complaints
•           Identify and process MDR's
•           How to process customer returns
•           Records and trend analysis
•           Complaint closure
•           Examples of tools currently being used to conduct investigations
•           How far and in-depth do you go with your investigations
•           What are current FDA "hot" buttons and trends, benchmarks and best                    practices for investigations
•           How to become a "good" investigator and the emphasis on closed-loop                   investigations
•           Written Procedures: Designated Complaint Handling Unit, Training and                  Records
•           Recent Enforcement Actions

Lecture 2:

Medical Device Reporting

•           Introduction to Medical Device Reporting
•           What are the key terms, definitions and forms?
•           MDR procedures and processes
•           What are the requirements for developing, maintaining, and                                     implementing written MDR procedures that apply to me?
•           How do you manage international reporting requirements under your                     complaint handling system?
•           Consider the relationship between MDRs and Risk Assessments

Lecture 3:

Exercise and Recap of Day 1

•           Exercise on Product Complaints/Complaint Handling
•           Quiz


(08:30 AM to 04:30 PM)

Day 2 Schedule

Lecture 1:

Medical Device Reporting

•           eMDR Electronic Medical Device Reporting
•           How to Report a Problem
•           Event Problem Codes and Manufacturer Evaluation Codes
•           MedWatch: Safety Information and AER Program
•           Completing Form FDA 3500A
•           What form should I use to submit reports of individual adverse events                    and where do I obtain these forms?
•           Where and how do I submit reports and additional information?
•           Does the information in my report constitute an admission that the device              caused or contributed to the reportable event?
•           What are the requirements for developing, maintaining, and                                     implementing written MDR procedures and maintain records/files that                   apply to me?
•           Requirements for Individual Adverse Event Reports
•           User Facility Reporting, Importer Reporting and Manufacturer Reporting                 Requirements

Lecture 2:


•           What happens in a medical device recall: Firm-initiated recall vs.                            mandatory recall
•           What information needs to be reported?
•           What types of records do companies need to keep?
•           Prior to notifying FDA, what steps should you have taken?
•           What are the dos and don'ts when informing FDA of a product problem?
•           Who should be involved in the decision process?
•           Who should be responsible for communicating with FDA?
•           What are the consequences of a recall?
•           What factors should you consider when determining whether or not to get               your product back?
•           How do you prepare for a post recall inspection?
•           What customer and other outside communications are necessary?
•           What documentation should be prepared?
•           How should the product liability implications of recall communications be              handled?
•           What is an effectiveness check?
•           Health Hazard Evaluations are conducted by FDA
•           How should you write your recall correspondence?
•           How do you determine that your recall is completed and what do you do                to close your recall internally and with FDA?
•           Create and use a recall operational
•           Understand what is required for the recall strategy as expected by FDA
•           Depth of recall and using a viable, sustainable and effective strategy
•           Understand why the documentation and paper trail are so critical and                     termination of a recall
•           Discuss most recent recalls not only for devices but pharmaceuticals and              why the numbers are alarming

Lecture 3:

Exercise and Recap of Day 2                                               

•           Exercise - MDR and Recall                              
•           Quiz



David R. DillsDirector of Regulatory Services at CROMSOURCE

David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations. He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific. He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, among other regulatory and compliance responsibilities. 

28-March-2019 To 29-March-2019 Philadelphia
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How to Reach


I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

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Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.


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