Understanding the nature of the microorganisms in manufacturing environments and on or in products is a vital step in medical device and pharmaceutical processing. In this webinar we will discuss the compendial requirements and recommendations regarding:The importance of microbial identification in an environmental monitoring program.How microbial identification is an important tool with gamma sterilized medical device validations in understanding a product bioburden baseline, in defining product families and in determining the frequency of dose audits.How microbial identification can be critical in investigations of environmental excursions, bioburden spikes, sterility failures, Biological indicator (BI) testing and Microbial Limits screening.Information will be included on microbial identification testing at Nelson Labs, from the benefit of sub-culturing organisms to the importance of a Gram stain as part of a polyphasic approach to identification.
Thu, Aug 29, 2013 - 11:00 am - 11:45 am
In this 20 minute webinar, Tony Holtz lays out basic design “rules” for successful plastic injection molding. As with many of life’s rules, some of these can be bent if absolutely necessary. But bending rules has costs and consequences, and this webinar addresses ways to work with the process and within its guidelines to make the most of injection molding’s flexibility and enormous potential.
Wed, Aug 28, 2013 (All day)
Available on Demand
In April of 2013 the FDA released a draft guidance on using ISO 10993 for biocompatibility. This draft is intended to replace the #G95-1 document on the current thinking and application of biocompatibility testing for medical devices. In the webinar we will cover three areas of the new document:1. Summary of ideas that are currently practices by the FDA but this is the first instance that they are put in writing 2. Concepts that can be used for justifying testing plans, and 3. New ideas that are not current thinking with the FDA that could change how you are testing.
Wed, Aug 21, 2013 - 01:00 pm - 02:00 pm
Epicor Software offers an on-demand webcast explaining how MDMs, tasked with complex compliance requirements, can use Enterprise Resource Planning (ERP) technology to simplify their businesses. Topics covered include using lean automated processes to streamline operations and simplify audits, future-proofing FDA compliance initiatives with agile technology, tracking Device Master Record (DMR) data and the detailed Device History Data (DHR), and approaching FDA Part 11 electronic signature software validation requirements to minimize disruptions.
Thu, Aug 1, 2013 - 02:00 pm - 03:00 pm
Available on Demand
The purpose of this webinar will be to provide quality assurance, design engineers, project engineers and all medical device manufacturers the knowledge to make decisions regarding which tests should be used to validate their sterile barrier system. By focusing on specific tests as outline in ISO11607, each individual will have the opportunity to view actual test methods, determine appropriate test samples and identify pros and cons to each method. Some of the methods viewed will consist of Bubble Emission (ASTM F2096), Microbial Ranking (ASTM F1608), Burst Testing (ASTM F1140), Seal Strength Testing (ASTM F88), and Dye Migration (ASTM F1929).
Wed, Jul 20, 2011 - 01:47 pm - Sun, Jul 5, 2015 - 01:47 pm
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- Pressure Sensors Databook - Supplier Resource
- Multiconductor Compatibility with Steam and Gas Plasma Sterilization - Supplier Resource
- The 3 Most Important Steps for Achieving a Uniform Coating Process - Supplier Resource
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