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