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Location: Room 207B
Title: IoPP Fundamentals of Medical Device Packaging - Day 3
Event Type: Workshops
Syllabus & Agenda
DAY THREE: Quality/Regulatory Requirements for Medical Device Packaging
Objectives: Students learn about quality and regulatory requirements for medical device packaging.
The day begins with a workshop on testing methods for medical packaging and then proceeds through classroom instruction on regulations and quality systems. The day ends with a session on assessing root cause analysis, with advice and perspective on what to do when confronted with the unexpected.
8 - 8:30 AM: Light breakfast
8:30 - 8:35 AM: Introduction
8:35 - 10 AM: Visual Inspection, Seal Width & Bubble Leak Testing
Rotation 1: Tensile Strength and/or Burst Testing
Instructors will demonstrate proper technique for performing tensile testing per ASTM F88 and burst strength per ASTM F2054. Tips and tricks will be shared for performing each method and their significance for packaging validation.
Rotation 2: Whole Package Integrity Testing
Students will observe a demonstration of the proper technique for performing ASTM F2096 and learn when this method is most applicable.
Rotation 3: Visual Inspection/Dye Testing
Instructors will demonstrate proper technique for performing visual inspection per ASTM F1886 and dye penetration per ASTM F1929. Discussions will explore common pitfalls and their significance.
10:05 AM: Break
10:20 AM - 12 PM: Regulations, Standards and Quality Systems for Medical Device Packaging
Regulations and standards are fun—keep telling yourself that. This session will show the essential regulations and standards to know and how to use them, with some interpretations provided. Remember that the primary concern is the product remains safe for use; next is to document the work that needs to be completed or was completed with a robust rationale—which could be repeated in five years (by someone else). This section will conclude with a discussion around the point that while practically no one reading the work will understand packaging like you, auditors and management usually can spot dubious information easily.
12 PM: Break
12:15 - 1:15 PM: CAPA, Risk Analysis, Troubleshooting and Remediation Strategies
What is a CAPA? How are root cause analysis tools and DMAIC methodology used? How are the problem statement and scope properly defined? This section will provide insights on how to address packaging engineering failure modes through CAPA using real cases by applying DMAIC principles.
1:15 - 1:30 PM: Course Close-out and Evaluation Survey
- - - - -
This new course, developed in conjunction with the IoPP Medical Device Packaging Technical Committee, introduces you to the requirements of medical device packaging.
The course consists of three half-day sessions and occurs at MD&M West in Anaheim. The curriculum includes classroom instruction and in-depth discussions, along with demonstrations at participating exhibitor booths of various machinery used to create medical device packaging.
Not technical? No problem. This course is designed for those new to packaging or medical device packaging. It can bring you up to speed on the essential knowledge needed to understand this complex packaging industry segment.
What topics are covered?
Who should attend?
Professional Instructors
Fundamentals of Medical Device Packaging is taught by a team of packaging professionals vetted and selected by the IoPP Medical Device Packaging Technical Committee.
CPE credit
Completing the Fundamentals of Medical Device Packaging course earns you 11 Continuing Professional Education (CPE) credit points. You must attend all training days to earn your Certificate of Completion and the CPE credit points. These can be applied toward the requirements for the IoPP Certified Packaging Professional (CPP) program.
