Webinar Details
When? Thursday, Jan. 21, 2016Creating a Simulated Distribution Test
Creating a Simulated Distribution Test |
Thursday, Jan. 21, 2016 • Postponed Until Further Notice |
Your Expert Presenter
Roberta Goode,
President and CEO,
Goode Compliance International
Roberta Goode is an executive with over 25 years of experience in the medical device industry. She is currently President and CEO of Goode Compliance International (GCI), a global leader in engineering and compliance services for medical device manufacturers, specializing in process validation, design control and risk management. Prior to founding GCI in 2002, Ms. Goode held positions of increasing responsibility in R&D, Manufacturing and Quality Engineering at Beckman-Coulter Corporation, Althin Medical, Inc. (acquired by Baxter Healthcare) and Cordis Corporation (a Johnson & Johnson company), where she contributed intellectual property in the form of four U.S. patents for percutaneous cardiovascular interventional devices. She holds a Master of Science degree in Biomedical Engineering and a Bachelor of Science degree from the University of Miami. Additionally, Ms. Goode has an adjunct faculty appointment at the University of Miami’s College of Engineering and is an ASQ Certified Quality Engineer.
When? Thursday, Jan. 21, 2016Register
This webinar been postponed until |
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Creating a Simulated Distribution Test
Ensure Your Products Reach Consumers Intact
Regardless of the type of regulated product you produce, it is good science, good business, and a worldwide regulatory and quality system requirement to validate that the packaging will protect the product’s integrity from the manufacturer’s shipping dock to the customer’s receiving dock. Failure to do so will prove costly to your company’s reputation and bottom line.
This is why it is vital for you to create a simulated distribution test to ensure that your product gets to where it needs to be in the condition it needs to be in.
Consider these two scenarios:
A drug product and its packaging were validated during the spring and summer prior to the product’s commercial debut; the launch of the product was scheduled for November. The first delivered batches of product arrived at the hospital after freezing during winter transport. The product had defrosted prior to use, but was inherently different, and in this case, ineffective for its intended use, having reached its freezing point.
A hospital regularly received a medical device that was sent overseas by cargo ship, and then delivered by truck or rail. An emergency caused the need for an urgent shipment of additional devices by airfreight. The product reached its destination in 48 hours, but the packaging had not been validated for air shipment. Upon its arrival, the customer found that the sterile barrier was breached, probably because of pressure changes with altitude, and the product was rendered unusable.
Both of these scenarios could have been made worse if the shipping damage had not been visually obvious; however damage to product and packaging are not always detectable with the naked eye. There are a number of non-obvious conditions and parameters to consider in the inclusion of package validation.
Join industry expert Roberta Goode on January 21st as she lays out all the conditions you need to be aware of while also providing a detailed breakdown of the steps you need to take to create a successful simulated distribution test. One that ensures your products don’t become damaged or a hazard en route to consumers.
In 90 minutes you’ll learn:
- The 11 steps to successful simulated distribution testing
- The three assurance levels for test intensity
- How to use CAPA and risk analysis to address failures during testing
- The 22 sets of regulations that may apply to your product
Who Should Attend |
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