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FDA Best Practices and Industry Benchmarking for Effective Complaint Processing, Trending and Analysis

June 14-16, 2016
  • Bethesda, MD

For 14 years, CBI’s Product Complaints Congress has been the industry’s gold standard for bio/pharmaceutical and medical device professionals responsible for complaint management. This “Go-To” event provides tailored content to assist professionals in measuring the effectiveness of their complaint handling system and gives attendees a trusted platform to benchmark and share experiences with industry thought leaders and peers. Navigate new industry trends and regulations surrounding FDA’s Quality Metrics Draft Guidance update, customer complaint trending and surveillance, devices/device constituent parts in combination products and so much more!


Assess the FDA’s Audit Process for Product Complaints

Vickie Anderson, Supervisor, Consumer Safety, FDA

Attendees Gain:

  • Expert insights from industry counterparts to better align complaint processes, benchmark product complaints industry practices
and gain the latest trending/analysis of complaint data
  • Breaking news and updates on the hottest topics surrounding complaints including FDA guidance, quality metrics, adverse event reporting, global reporting requirements and social media
  • New thought leadership for 2016 with 8 different 90-minute Deep Dive Sessions with multiple case studies and Product Complaints real-world scenarios
  • In-depth content as part of our in-conference 3-hour workshop on the life cycle management of adverse event reports
  • Opportunities to engage and ask questions during each segment

All New Industry Trends and Regulations:

  • Customer Complaint Trending and Surveillance
  • Devices/Device Constituent Parts in Combination Products
  • FDA’s Quality Metrics Draft Guidance Update

Benchmarking Tools, Best Practices and Practical Expertise On:

  • Handling customer complaints and investigations in a global economy
  • Establishing a robust global complaint intake process
  • Navigating the legal implications of complaint communications
  • Developing risk assessments for drug products with device components
  • Determining and reporting adverse events vs. product complaints
  • Implementing a risk-based approach to enhance your complaint handling system
  • Interpreting and responding to social media —
    The impact on the complaint management team
  • Establishing links between complaints and pharmacovigilence to ensure patient safety


Life Cycle Management of Adverse Event Reports

Our Elite Speaker Faculty: Join Us and Learn from 20+ Experts Over 2.5 Days

  • Vickie Anderson, Supervisor, Consumer Safety, FDA
  • Khaudeja Bano, M.D., Senior Medical Director,
    Medical Device Safety Head, Medical Safety Evaluation, AbbVie Inc.
  • Paul Beninger, M.D., MBA,
    Therapeutic Area Head, Pharmacovigilance and Epidemiology, Sanofi
  • Patrick Caines, Ph.D., MBA, Director, Product Surveillance, Baxter Healthcare
  • Tatyana Chorny, Manager, Case Management, HeartWare, Inc.
  • Maureen Ellis, RN, Director, Chemistry, Manufacturing and Controls/Device Safety, PV Operations, Global Patient Safety, Amgen
  • Leigh Gear, BSc (Hons) Pharmacology,
    Business Process & Compliance, PV Operations, Global Patient Safety, Amgen
  • Brett Godfrey
    Global Post Market Surveillance, Senior Manager, Lumenis Ltd.
  • Steve Greer, Corporate QA External Engagement Leader, Procter & Gamble
  • Jacqueline Grissinger,
    Director, Office of Consumer Medical Safety, Johnson & Johnson
  • Sonali Gunawardhana, Of Counsel, Wiley Rein LLP
  • Lars Juel Hansen,
    Principal Device Specialist, Complaint Surveillance, Novo Nordisk A/S
  • Rikke Lewinsky, Ph.D., Specialist, Complaint Surveillance, Novo Nordisk A/S
  • Krista Liotta, Associate Director, Global Complaint Intake, Merck & Co.
  • Craig Ostroff, PharmD, RPh, Senior Director, Global Regulatory Affairs, Otsuka
  • Peter S. Reichertz, Partner and Leader of Food and Drug Law Group,
    Sheppard Mullin Richter & Hampton LLP
  • Dick Roy, Director of Product Surveillance, GE Healthcare
  • Jacob Severns, Director, Quality Assurance, Product Complaints, Amgen
  • Robert S. Walsh, M.D., MBA,
    Medical Director, Pharmacovigilance and Patient Safety, AbbVie
  • Lisa Withers, Manager, Business Process — Complaints, Johnson & Johnson
  • Dan Wozinski, RPh, MB, Global Medical Device Surveillance,
    Sanofi Global Pharmacovigilance and Epidemiology

Previous Attendee Acclaim:

It is invaluable to experience benchmarking and industry networking and knowledge (best practice) sharing. This forum was perfect for encouraging discussions, building relationships, stimulating discussion, validating ideas and concerns – very beneficial.

Associate Director, QA, Alcon

I believe that some of the information I gained at this conference
could potentially save my company millions of dollars.

Complaint Manager, Sanofi Pasteur

CBI’s Product Complaints Congress is one of the best events
to attend to find out the latest with the ever changing
pharmaceutical and medical device industries.

Manager, Bayer

June 14-16, 2016 | Hyatt Regency | Bethesda, MD