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Complaints, MDRs & Recalls Workshop

February 11, 2020 to February 12, 2020
701 Pennsylvania Avenue #800, Washington, DC

Led by industry and FDA experts, this workshop will provide an in-depth overview of how organizations can best tackle complaints, MDRs and recalls. Together with industry and FDA experts, we've developed a program designed to provide you with insights and strategies that you can immediately implement at your organization.

Workshop topics will include:

  • Complaints: Definitional questions
  • Setting up a complaint system
  • Handling complaints & trending
  • Recalls and other field actions
  • Understanding MDRs
  • An introduction to Health Hazard Evaluation (HHE)
  • Reporting and products liability
  • Part 806 reports of removals and corrections
  • Current FDA inspection and enforcement trends
  • Measuring the effectiveness of your complaint system
  • Recall procedures
  • Communicating with FDA - before, during and after a recall
  • Crisis management
  • Creating a recall strategy

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Feb 11, 2020

8:30 – 9:00 am

Registration and Continental Breakfast

9:00 – 9:05 am

Welcome and Introductions

9:05 – 10:00 am

Defining Complaints
Mike Heyl, Hogan Lovells
Ted Wilson, Hogan Lovells

  • Distinguishing among product complaints, satisfaction complaints, customer inquiries, and service calls
  • Differentiating instrument repairs and complaints

10:00 – 10:45 am


Elements of an Effective Complaint Management System
Youssef Halas, GE Healthcare

  • Risk management influences on complaint handling decisions
  • Determining primary lead for complaint management system
  • Role of service and sales calls within complaint handling procedures
  • Training and Motivating Service and Sales personnel to identify and report complaints
  • Responsibilities of other departments
  • Maintenance of files: Who, Where, How long
  • Relationship to CAPA system

10:45 – 11:00 am


11:00 – 12:00 pm

Handling Complaints & Trending
Mike Heyl, Hogan Lovells
Ted Wilson, Hogan Lovells

  • Importance of establishing a process for handling complaints
  • Example SOPs for sorting out potential MDRs and product complaints
  • Steps FDA expects to see a company taking to address potential MDRs, product complaints and other reportable events
  • How to perform trending
  • Examples of trending and analysis of service calls and product complaints
  • FDA’s expectation for trending complaints from non-US markets

12:00 – 1:00 pm


1:00 – 2:00 pm

Understanding MDRs
Steven Niedelman, King & Spalding

  • Key terms, definitions and forms
  • Investigating complaints, determining if they are MDRs
  • Identifying reportable malfunctions vs MDRs
  • MDR flow chart
  • Conducting risk assessments
  • When not to report an incident
  • MDR reports and reporting under 21 CFR Part 806
  • Managing international reporting requirements under your complaint handling system
  • Summary Reporting
  • Alternative reporting mechanisms

2:00 – 2:45 pm

An Introduction to Health Hazard Evaluation (HHE)
Allison Fulton, Sheppard Mullin

  • Health Hazard Evaluation defined
  • When HHE should be initiated
  • Elements of a well-documented HHE
  • Common mistakes
  • How HHEs are documented and approved
  • Maintaining records
  • FDA’s involvement in HHE and classification

2:45 – 3:00 pm


3:00 – 3:30 pm

Reporting and Products Liability
Kathryn Klaus, Medmarc

  • Implications of incorrect reporting; impact on products liability

3:30 – 4:15 pm

Current FDA Inspection & Enforcement Trends
Neil Mafnas, FDA

  • FDA perspective on post-market issues and field actions
  • Current enforcement trends
  • FDA inspectional activities
  • FDA expectations for the industry

4:15 – 5:15 pm

Measuring the Effectiveness of Your Complaint System
Allison Fulton, Sheppard Mullin

  • Maintaining an appropriate complaint handling system in a risk-based post-market environment
  • Auditing a complaint handling system
  • Using audits to determine whether your complaint handling system is effective
  • Ensuring the electronic records database handling complaints complies with 21 CFR Part 11
  • Performing and documenting a failure investigation
  • Investigating complaints when samples are not available/product is not returned
  • Employee guidelines for how and when to respond to customer complaints
  • Obtaining and managing data

5:15 – 6:15 pm

Networking Reception

Feb 12, 2020

8:30 – 9:00 am

Continental Breakfast

9:00 – 9:45 am

Recalls: Definitions, Practices, and Current FDA Perspective
Maureen Bernier, FDA

  • Defining Recalls
  • Relationships between MDRs, Corrections, Removals, and Recalls
  • Recall trends
  • Voluntary vs. mandatory recalls
  • Corrections, removals, market withdrawal, stock recovery, and routine servicing
  • Reporting requirement exemptions
  • Recall classification
  • FDA expectations

9:45 – 10:45 am

Part 806 Reports of Removals and Corrections
Maureen Bernier, FDA

  • Key elements of 21 CFR Part 806
  • Examples of items that need to be reported
  • Filing an 806 if you have a recall or advisory notice
  • Information to be reported
  • Types of records to be maintained
  • Steps to take prior to notifying FDA
  • Dos and don'ts when informing FDA of a product problem
  • Strategy for removals and corrections vs recalls

10:45 – 11:00 am


11:00 – 12:00 pm

Recall Procedures
Tony Blank, Infinity Biomedical Group

  • Necessity of a team
  • Pivotal nature of the regulatory affairs function during a recall
  • Recall Procedures – How it works in the best of all possible worlds
    • Hypothetical example of a voluntary recall in which everything takes place perfectly according to plan.  Defines the sequence of events, interaction between FDA-industry-distributors-purchasers-physicians-patients, and the rationale for each step
  • Recall Procedures – What happens in the real world
    • Hypothetical example of a voluntary recall plagued by all of the confusion, uncertainty, disagreements, conflicting interests, mistakes, miscommunications, and other problems that occur

12:00 – 1:00 pm

Networking Lunch

1:00 – 2:00 pm

Getting to Root Cause - Understanding the Problem
Eric Claude, MPR Associates, Inc.
Lynessa Erler, MPR Associates, Inc.

  • Root causes analysis methodology
  • Data collection strategies
  • Organizing and evaluating facts
  • Analyzing potential causes
  • Common pitfalls and potential biases
  • Case studies

2:00 – 3:00 pm

Communicating with Your Team and FDA Before, During and After a Recall
Dorothy Henckel, Guidehouse

  • Communication with FDA
  • Reporting recalls through 21 CFR Parts 7 and 806
  • Tools available from FDA
  • Recall vs. Enhancement guidance
  • Individual(s) responsible for communicating with the FDA
  • Priorities to keep in mind when developing an internal communications plan
  • Customer and other outside communications
  • Priorities to keep in mind when developing a field team communications plan
  • Documentation to include on the notification letter
  • Effectiveness check defined
  • Writing your recall correspondence
  • Determining that your recall is completed

3:00 – 3:15 pm

Networking Break

3:15 – 4:15 pm

Regulatory and Business Considerations When Developing a Recall Strategy 
Ginger Glaser, Monteris Medical

  • Elements of a recall strategy
  • Examples of robust recall strategies, anecdotes of deficiencies
  • Effective contingency plans – who, what, where, when, how
  • Product identification issues
  • Product distribution records
  • Auditing internal recall procedures
  • Communicating your strategy effectively to FDA
  • Global considerations

4:15 – 4:45 pm

Case Study: Lifecycle of a Recall
Ginger Glaser, Monteris Medical

4:45 pm

Meeting Adjournment

Speakers include:

Dr. Neil Mafnas, FDA
Regulatory Officer in the United States Public Health Service Commissioned Corps. He is currently assigned to the Medical Device Single Audit Program (MDSAP) Team in FDA’s Center for Devices and Radiological Health, Division of International Compliance Operations. As a member of the MDSAP Team, LCDR Mafnas’ duties include the creation/development of policy, procedures, training and conducting outreach. Additionally, Neil serves as a Subject Matter Expert and Project Manager for the development/implementation of MDSAP’s IT Portal. Neil began his career with the FDA in 2010 as a Consumer Safety Officer (CSO) in the Office of Compliance at the Center for Devices and Radiological Health. As a CSO in the General Hospital Devices Branch, he worked on medical device inspection classifications, recall classifications, medical device complaints and Consent Decrees for Permanent Injunction. Neil also works closely with the Association for the Advancement of Medical Instrumentation as one of the Agency’s Quality System Regulation instructors. LCDR Mafnas has been in the Public Health Service since November 2011. Prior to coming to the FDA, he worked as the Safety Manager for a logistics firm. Neil also served in the United States Air Force as an active duty Space and Missile Maintenance Officer from 2001 – 2007. LCDR Mafnas holds a Bachelor’s Degree in Biology from the University of Texas at Arlington, and a Master’s of Science in Health Sciences from the University of Central Florida.

Mike Heyl, Hogan Lovells
Helps medical device companies navigate myriad regulatory and business matters. He guides clients through U.S. Food and Drug Administration (FDA) regulations, requirements, and compliance issues. These issues include FDA's Quality System Regulation (QSR); adverse event reporting; recall reporting requirements; FDA inspections and enforcement actions, such as Warning Letters; defense strategies; and corrective and remedial action plans. He represents large multinational corporations facing FDA and criminal enforcement and helps small start-ups develop and implement post-market compliance programs. Because he understands FDA's requirements for importing and exporting medical devices, Mike is frequently called on to negotiate the release of detained goods being imported to the U.S. He has assisted in the defense of criminal investigations by the U.S. Department of Justice, conducted internal investigations of whistleblower complaints, and prepared strategies for resolving such issues. Mike also works with device companies in conducting regulatory due diligence and negotiating corporate mergers and acquisitions and initial public offerings. He has been involved with numerous transactions ranging from multibillion-dollar acquisitions to the negotiation of supply and distribution agreements. Mike is a frequent speaker on regulatory compliance and enforcement issues in the device industry. He also serves as the device representative on the Hogan Lovells Life Sciences Steering Committee.

Ted Wilson, Hogan Lovells
Helps companies of all sizes find workable business solutions to complex post-market compliance issues. Whether it is responding to FDA inspectional observations or a warning letter, assisting in the defense of a criminal investigation, conducting an internal investigation of alleged regulatory violations, executing product recall strategies, or interpreting the FDA's complex adverse event report and advertising and promotion requirements, Ted helps navigate the complicated regulatory environment in which medical device companies that market products in the U.S. must operate. Education includes J.D., University of Virginia School of Law, Recipient of Charles J. Frankel Award in Health Law, 1990 and A.B., Davidson College, cum laude, Phi Beta Kappa, 1987.

Youssef Halas, GE Healthcare
Global Product surveillance Director for X-ray, Lunar and ICAR products for GE Healthcare. He has been with GE Healthcare for 10 years (Service, applications, Project Management and Post Market Quality), 5 years in Europe and the Middle East and another 5 years in the US. He is the business owner for the GE postmarket quality management system, has managed cross-functional initiatives related to the Quality Management system, worked with the service team to enhance service record quality, applied Lean concepts in complaints processes, and led the UDI implementation efforts within GE Healthcare. He has 17 years of healthcare experience in different companies and different regions. He has an MS degree in Medical Microbiology and Immunology.

Kathryn Klaus, Esq., Medmarc
Risk Management Attorney with Medmarc Insurance Group. Her focus is on legal matters faced by participants in the life sciences industry, specifically FDA regulatory compliance. She began her career with FDA’s Center for Biologics Evaluation and Research, where she worked on the Broad Spectrum Autism litigation under the National Childhood Vaccine Injury Act. After leaving FDA, she worked in private practice with two national law firms, counseling clients through all phases of the regulated product life cycle, including development and approval, manufacturing, labeling and advertising, and post-market concerns and enforcement. She has advised clients regarding defense against regulatory enforcement actions, including FDA 483 Inspectional Observations, Warning Letters, U.S. Customs detentions, product recalls, and DHHS OIG exclusion proceedings. She has also counseled clients through all health law-related aspects of major transactions, from conducting facility and records compliance auditing during due diligence investigations, to federal and state licensure requirements, and the development and implementation of improved compliance programs post-closing. She now brings this experience in navigating the FDA landscape to Medmarc, where she works with colleagues in-house, as well as with policyholders, in developing regulatory compliance strategies in an effort to mitigate products liability losses.
Ms. Klaus is a graduate of The Catholic University of America, Columbus School of Law, and the College of the Holy Cross. She is a member of the Massachusetts Bar.

Allison Fulton, Sheppard Mullin
Partner in Sheppard Mullin’s Life Sciences and FDA team and is based in the firm's Washington, D.C. office. Allison advises life sciences companies, including pharmaceutical, medical device, dietary supplement, food and cosmetic companies, in matters relating to the development, manufacture, and marketing of products regulated by the U.S. FDA. Allison’s areas of focus include assisting U.S. and international companies comply with current Good Manufacturing Practice (GMP) and the Quality System Regulation (QSR). She regularly advises companies on preparing for FDA inspections, responding to FDA Form 483s and Warning Letters, remediating data integrity issues and handling adverse events and medical device reports (MDR). Allison has led numerous internal investigations involving allegations of off-label promotion and healthcare fraud and abuse, and she regularly counsels clients on promotion and labeling matters. Allison has a passion for novel technologies and advises clients on product approval and clearance strategies for innovative products, including digital health technologies, precision medicine, and combination products. She provides regulatory advice during acquisitions of life science companies, and other transactions involving medical products, including product licenses and quality agreements. Prior to her legal career, she worked as a software engineer where she specialized in software validation. Allison earned her law degree from the University of Texas School of Law, where she was the managing editor of the Texas Intellectual Property Law Journal. She received her B.S. in Industrial Engineering from Northwestern University. Allison devotes her pro bono practice to assisting veterans obtain benefits for service-connected disabilities.

Maureen Bernier, FDA
Biomedical Engineer with FDA, has worked in CDRH Recalls for 17 years, as well as other departments in CDRH. She is a licensed Professional Engineer. Maureen has designed and developed medical devices at the National Institutes of Health (NIH) and in the diagnostic device and orthopedic industries, including two patents for hip implants. Her industry experience has given her insight into the design, manufacture, and use of many types of medical devices, as well as the procedures that manufacturers use for problem evaluation and corrective actions.

Tony Blank, Infinity Biomedical Group
President of Infinity Biomedical, a small regulatory consulting practice specializing in providing strategic and tactical regulatory support for medical devices and combination products. Prior to this, Mr. Blank spent twelve years at Boston Scientific Corporation in both Corporate and Business regulatory leadership roles. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products. He was likewise an active representative for Boston Scientific, the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participating in numerous Industry Working Groups – including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired). He remains involved in developing and delivering meaningful educational programs in the field of Regulatory Affairs and has been a regular speaker at educational events. In addition to his time at Boston Scientific, Mr. Blank has worked with Cardiopulmonary, Surgical, Ophthalmic, Vascular Access and Critical Care medical devices.

Dorothy Henckel, Guidehouse
Currently works as a senior regulatory scientific advisor for Navigant Consulting, Inc. She started her career as a scientist at Roche Diagnostics, where she worked in the departments of R&D, operations and quality gaining experience with nearly every aspect of design control. Outside of healthcare, Dorothy has much experience with programming strategy with roles as the director of acquisitions for the Documentary Channel, board president of the Indianapolis Int’l Film Festival, teacher at an inner-city high school and is an award-winning producer of short films. Trained as a chemist, her career path has led her from science to television and back to science. Dorothy was named “Person you Should Know" in 2009 by the Indianapolis Star and “Green Mover and Shaker" in 2007 by NUVO News Weekly. As if her background and experience was not impressive enough, Dorothy holds the 2017 North American Champion title of Linear Bocce (a game only played in Indianapolis).

Ginger Glaser, Monteris Medical
Joined Monteris Medical in 2016 as the Vice President of Quality and Regulatory and currently serves as the company’s Chief Technology Officer. Prior to joining Monteris, Ginger spent 19 years at American Medical Systems (AMS), serving in a variety of executive and leadership roles in Regulatory, Quality, Project Management, Operations, and Clinical Affairs. As a Project Manager, Ginger was responsible for the oversight, development, and launch of several ground-breaking products. Ginger is regulatory affairs certified (RAC) and is highly involved in a number of industry-level activities, including serving as chairperson for the joint FDA/Industry working group convened by the American Association of Medical Instrumentation (AAMI) on integrating risk-benefit assessments into post-market compliance decision-making. Ginger received a Bachelor of Science and a Master of Science in Biomedical Engineering from Texas A&M University and completed Ph.D. coursework in Biomedical Engineering at the University of Minnesota. She was named one of “110 Women to Know in MedTech in 2017,” by Becker Hospital Review.

Eric Claude, MPR Associates, Inc.
Vice President of MPR’s Health and Life Science Division. With more than 30 years in the industry, Mr. Claude provides leadership and experience in advising clients on strategies for product development as well as recovery when things go sideways. His principal focus is implementing methods to speed the development process through integrated, multi-disciplinary project teams and application of risk-based engineering approaches.

Lynessa Erler, MPR Associates, Inc.
Director of Product Testing with MPR, assisting clients and MPR’s internal design teams with design verification, test design, method validation and automated test tool development. With more than 20 years of experience, Ms. Erler has significant expertise in the management of software development, verification, and validation, as well as root cause investigations.

Steven Niedelman, King & Spalding
Serves as lead quality systems and compliance consultant to the FDA and Life Sciences practice at King & Spalding. Steven specializes in regulatory, enforcement and policy matters involving industries regulated by the Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act. Steven joined King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice president of Quintiles Consulting. Steven consults with manufacturers, importers and new product developers, as well as with firms involved in or facing enforcement actions. He helps firms develop corrective action plans so their business needs are properly balanced with regulatory requirements in order to achieve compliance without compromising objectives. He provides training and guidance to industry professionals on all FDA requirements, including quality systems requirements, inspection preparedness and post-market obligations, as well as to executives concerning their management responsibilities as well as FDA expectations.

After a distinguished 34-year career, Steven retired from the FDA in 2006. At the agency, he served as deputy associate commissioner for Regulatory Affairs and as chief operating officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs, including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. Additionally, he assisted in the day-to-day management of FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations. While at ORA, Steven served as the principle liaison to the Center for Devices and Radiological Health, and was a member of the Global Harmonization Task Force Steering Committee, the FDA/Medical Device Industry Grassroots Initiative Steering Committee and the CDRH Post Market Initiative Steering Committee. He also served on the steering committee to the pharmaceutical “cGMP for the 21st Century” initiative, as well as the Counterfeit Drug Task Force. Prior to joining the Office of the Associate Commissioner, Steven was the director and deputy director of the FDA’s Office of Enforcement, where he was responsible for oversight and consistency of compliance policy, enforcement and recall activities to ensure fair implementation by the agency's five product centers. During his tenure, he presided as the Chairman of FDA’s Compliance Policy Council. Steven currently participates as a member of the Medical Devices Committee at the Food and Drug Law Institute, and as a member of the Editorial Review Board for FDA News GMP publications directed at the pharmaceutical and medical device industries. He has also served as vice president of the FDA Alumnae Association. Before joining the Office of Enforcement, Mr. Niedelman spent nearly 24 years in the Office of Compliance at the Center for Devices and Radiological Health in a number of management positions. During nearly 24 years at CDRH, he was responsible for implementing many of the newly-created statutory requirements and drafting and shaping many of the regulations and policies affecting the sale, distribution and promotion of medical devices. He began his FDA career in 1972 as an investigator in FDA’s New York District Office.

The Complaints, MDRs & Recalls Workshop will take place February 11-12 at the AdvaMed Office in Washington, DC.

View hotel list

701 Pennsylvania Ave. N.W.
Suite 800
Washington, D.C.

Registration Fees

AdvaMed Member Registration: $1395.00

Accel Member Registration: $695.00

Government and Non-Profit Registration: $695.00

Non-Member Registration: $1,895.00

Note: Early-bird pricing is available for AdvaMed Members and Non-Members. Register by January 25, 2020 for $200 off your registration!