Secrets of Smart Risk-Based Device Packaging - Webinar CD/Transcript

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Secrets of Smart Risk-Based Device Packaging: Don't Become Another Recall Statistic

Think you’ve got a handle on your medical device packaging? So did Customed — until it was hit with a record-breaking recall attributed directly to packaging flaws.

Customed recalled 233 Class I products representing several hundred thousand units. An outlier? Maybe. Maybe not.

Flawed packaging was cited in nearly 400 Class II and III other FDA recalls between 2010-2012.

Numbers don’t lie.

If your job is to manage packaging controls and QA/QC, the first step is to identify if you’ve got a problem. The second is to take the steps required to fix it. This presenation will feature tips and tricks such as:

  • How to navigate myriad packaging standards that only increase each year
  • How to identify the most important flaws or shortcomings in your medical device packaging program
  • How to show an FDA inspector that you understand the agency’s packaging requirements
  • Understand what FDA audit spots investigators are focusing on during device inspections
  • Troubleshoot your vulnerable packaging areas and remediate your program based on defensible risk assessment
  • How to learn from the mistakes of others to apply proven risk-based decision-making when developing a stronger device packaging program
  • What FDA investigators consider when they’re debating if it’s time to recall your product

Learning Objectives

In just 90 minutes, you’ll receive a deep understanding of how packaging engineering is often overlooked, how the FDA is auditing packaging and best practices to use cost-effective risk management to improve compliance.   

  • Medical device manufacturing and executives
  • QA/QC managers and directors
  • Production managers
  • Production supervisors
  • Quality inspection and test managers
  • Purchasing managers
  • Supply chain specialists
  • Process development staff
  • Compliance officers
  • Training managers
  • Regulatory affairs and compliance professionals
  • Engineering and design controls teams
  • Executive management
  • General/corporate counsel
  • Personnel new to the industry
  • Risk management specialists
  • Strategic planning and business development staff
  • Validation specialists, scientists, engineers

Abhishek (Abhi) Gautam, Manager of Packaging Engineering, ConMed
Abhi is a packaging engineer with 12 years of experience in medical device sector (orthopedics, cardiovascular and surgical) and currently works as Packaging Engineering Manager at ConMed Corporation. With his strong exposure to a complex matrix of quality and regulatory function with respect to the medical device (terminally sterilized) packaging industry, he has gained significant insight and knowledge. He is currently pursuing a Graduate Certificate in Strategic Management from Harvard University. He also holds a MS degree (Packaging Science) from Rochester Institute of Technology, Rochester, NY and a BE degree (Printing Technology) from India. He has written multiple articles and presented multiple times and enjoys contributing to the medical device packaging industry. He is also a co-inventor on several ground breaking patents in the field of packaging design and application.