Packaging Validation Sessions at MD&M Minneapolis

The Medical Design & Manufacturing (MD&M) Minneapolis event will feature special sessions on medical device pack-aging with Douglas Stockdale of Stockdale Associates Inc. as chairperson. The first session will focus on packaging engineering and will include an overview of ISO 11607 revisions with special attention on the standard’s Clause 6, as well as utilizing packaging design software and equipment considerations for tray sealing. The second session will focus on packaging validation and compliance. This session will cover sterile barrier system validation and expiration dating considerations, form-fill-seal packaging equipment qualifications, distributions and shipping validation, and appropriate sample sizes for packaging testing requirements. The event will be held October 24–26. It is presented by Canon Communications (Los Angeles), the publisher of PMP News.

303 Medical Device Packaging

Chair: Douglas Stockdale, Stockdale Associates Inc.

Part I—Packaging Engineering

• IoPP Update for Medical Device Package Engineers. Eric Carlson, senior engineer, Adalis Corp. Packaging Solutions Group of Minneapolis

• ISO 11607 Revisions—Understanding Clause 6. Pat Nolan, COO, DDL

• Equipment Considerations for Tray Sealing. Tom Misik, vice president marketing, Belco Equipment

• Benefits of Utilizing Packaging Design Software to Optimize Packing Efficiency. Anthony Bantug Sr., packaging engineer, Baxter Healthcare

307 Medical Device Packaging, cont.

Chair: Douglas Stockdale, Stockdale Associates Inc.

Part II—Packaging Validation and Compliance

• Sterile Barrier System Validation and Expiration Dating Considerations. Randall Troutman, project manager, global packaging development, Smith & Nephew

• Packaging Equipment Qualifications for Form-Fill-Seal: IQ, OQ, PQ. Douglas Stockdale

• Packaging Testing Requirements: What is the appropriate sample size? Nick Fotis, director package engineering, Cardinal Health

• Distribution and Shipping Validation. Marci-Ann Ando, CCP, senior packaging engineer, Celera Diagnostics


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