Topics for the day include:
* Distribution Simulation
* Test Method Validation
* Quality Assurance & Regulatory Compliance
* Material Testing Standards
Course Topics
Distribution Simulation
Presented by Scott Levy, Packaging Engineer at DDL
Distribution Simulation is a uniform way of evaluating shipping units through the use of laboratory equipment that subjects the packaging system to specific hazards that may occur within the anticipated distribution environment. Understanding the methodologies behind the processes is vital for medical device manufactures to get their product to market. This presentation will examine the most common methodologies being utilized by medical device manufacturers including ASTM and ISTA procedures. It will also expose the benefits and drawbacks of certain methodologies and offer valid solutions.
Material Testing Standards
Presented by Al Gale, Product and Material Engineer
This type of testing centers around the product, all by itself, usually in it's operational form. For the most part there is no protection surrounding the device. We concentrate on the physical characteristics of the device like strength, pressure, vibration, and shock. Sometimes we have to add in environmental elements of temperature and humidity into the equation.
Method Validation
Presented by Corey Hensel, Director of Operation
Strength and Integrity Testing and Test Method Validation are vital in determining the sterility (or lack therefor) in medical package testing for MDM 's They are essential for your 501K submission and in getting your devices to market. With the speculation of increased regulation, it is imperative to ensure that the rest results you are provided are credible and dependable.
Quality Assurance and Regulatory Compliance
Presented by Kim Pratt, Quality Assurance Manager at DDL
DDL feels that it is essential for customers to understand their vendors level of standard for quality assurance. During her presentation, Kim will explain the benefits of a working with a vendor that understands their customers needs for regulatory compliance and the benefits of having a solid quality system in place for both the testing lab and the customer.
* Distribution Simulation
* Test Method Validation
* Quality Assurance & Regulatory Compliance
* Material Testing Standards
Course Topics
Distribution Simulation
Presented by Scott Levy, Packaging Engineer at DDL
Distribution Simulation is a uniform way of evaluating shipping units through the use of laboratory equipment that subjects the packaging system to specific hazards that may occur within the anticipated distribution environment. Understanding the methodologies behind the processes is vital for medical device manufactures to get their product to market. This presentation will examine the most common methodologies being utilized by medical device manufacturers including ASTM and ISTA procedures. It will also expose the benefits and drawbacks of certain methodologies and offer valid solutions.
Material Testing Standards
Presented by Al Gale, Product and Material Engineer
This type of testing centers around the product, all by itself, usually in it's operational form. For the most part there is no protection surrounding the device. We concentrate on the physical characteristics of the device like strength, pressure, vibration, and shock. Sometimes we have to add in environmental elements of temperature and humidity into the equation.
Method Validation
Presented by Corey Hensel, Director of Operation
Strength and Integrity Testing and Test Method Validation are vital in determining the sterility (or lack therefor) in medical package testing for MDM 's They are essential for your 501K submission and in getting your devices to market. With the speculation of increased regulation, it is imperative to ensure that the rest results you are provided are credible and dependable.
Quality Assurance and Regulatory Compliance
Presented by Kim Pratt, Quality Assurance Manager at DDL
DDL feels that it is essential for customers to understand their vendors level of standard for quality assurance. During her presentation, Kim will explain the benefits of a working with a vendor that understands their customers needs for regulatory compliance and the benefits of having a solid quality system in place for both the testing lab and the customer.
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