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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:
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.
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.
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