International Drug & Device Recalls - Webinar CD/Transcript

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International Drug & Device Recalls

Like it or not — despite the complicated process you have to go through to receive regulatory approval — product recalls are a reality, in the U.S. and in every other country where your product is sold.

Recalls continue to dominate headlines year after year. While there is a push for countries to harmonize their standards, this is one area where there are still dramatic disparities between regulatory agencies.

Those unprepared will see millions siphoned from their bottom lines — spent on everything from damage control advertisements to public relations experts — with countless man-hours wasted on spin control instead of new product development.

Join Recall Strategist Chris Harvey as he breaks down the finer points of preparedness for a drug or device recall — at home or around the world.

The topics to be covered include:

  • Recall Landscape: Understand current recall metrics and trends.
  • Understand reporting requirements and the agencies that govern product safety.
  • Gain insight into how to prepare your company to manage a Global recall.
    • The who, what, why, and when of a recall plan
    • Global Mock Recalls Execution
  • Examine the steps involved in executing a global recall
  • Hear best practices for streamlining the global recall process while protecting your bottom line and ensuring patient safety
  • Examine how social media has been utilized during a product recall
  • Discover frequent pitfalls and ways to overcome them
  • Review a few case studies of well managed  and poorly managed recalls
  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Data management and statistics personnel
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • QA/QC personnel
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff
  • Training personnel

Chris Harvey is a Recall Strategist for Stericycle/ExpertSOLUTIONS, where he works with clients to ensure flawless implementation and customer integration throughout the entire product recall process. Chris assists in the scoping, plan development, and recall execution for a diverse set of industries, including pharmaceutical, medical device, food & beverage, and consumer products.

Throughout his career, he has managed more than 1,000 recalls, including hundreds of high-profile recalls and withdrawals for the nation’s largest pharmaceutical and CPG companies. With his wide range of experience, Chris offers Stericycle clients proven and efficient solutions to challenges arising from every aspect of the recall process; from initial planning and preparation to the full scale execution of a product recall. Additionally, Chris works with numerous law firms and PR firms across all industries to help their clients mitigate recall related risk.

Chris is recognized as an expert in the recall industry and routinely speaks on best practices for recall planning and execution at trade shows, conventions, and conferences. Chris is a proud graduate of Purdue University, where he earned his Bachelor’s Degree in Law and Society.