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FDAnews Announces: Secrets of Smart Risk-Based Device Packaging: Don’t Become Another Recall Statistic Webinar, March 10, 2015

Falls Church, VA (PRWEB) February 23, 2015

Secrets of Smart Risk-Based Device Packaging:
Don’t Become Another Recall Statistic
**FDAnews Webinar**
March 10, 2015 — 1:30 p.m. – 3:00 p.m. EST

On March 10, join one of the world’s top device packaging experts — Abhi Gautam of ConMed — for a case study-driven webinar that will teach attendees how to leverage a risk-based packaging approach to prevent recalls and audits. All without busting a hole in the compliance budget.

Do devicemakers think they have a handle on medical device packaging? A manufacturer thought it did — until it was hit with a record-breaking recall attributed directly to packaging flaws.

They 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.

For those whose job it is to manage packaging controls and QA/QC, the first step is to identify if there is a problem. The second is to take the steps required to fix it. This webinar 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 a medical device packaging program
  • How to show an FDA inspector that the manufacturer understands the agency’s packaging requirements
  • Understand what FDA audit spots investigators are focusing on during device inspections
  • Troubleshoot vulnerable packaging areas and remediate the 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 a product

In just 90 minutes, attendees will 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.

Meet the Presenter:
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.

Who Will Benefit:

  • 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

Conference Details:
Secrets of Smart Risk-Based Device Packaging:
Don’t Become Another Recall Statistic
**FDAnews Webinar**
March 10, 2015 — 1:30 p.m. – 3:00 p.m. EST

$287 per site

Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at

Source: PRWeb
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