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2 months ago | 
pharmaceuticalonline.com | Brian Svaton |Nikka Densok USA |Claire Brunet |Susan Youngquist
Webinar: Optimizing Human Factors Testing: Engaging End-Users in Medical Device DevelopmentIntegrating human factors testing in healthcare is crucial for medical device safety and effectiveness. This presentation highlights challenges in real-world testing, emphasizing user comfort and realistic environments to ensure accurate feedback. It covers strategies for optimizing recruitment, testing, and participant engagement while fostering a supportive atmosphere. Click here to learn more.
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Aug 29, 2024 | 
pharmaceuticalonline.com | Brian Ball |Nikka Densok USA |Anthony Qu
What Do You Need To Know About AI Readiness? Unlock the full potential of AI and digital solutions with these practical steps to begin moving your biopharma organization's goals forward with optimized data usage. 6 Reasons To Consider HVLD Vs. Vacuum Decay For Pharma ProductsHere, two of the more common methods for container closure integrity testing, high voltage leak detection (HVLD) and vacuum decay, are compared.
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Jul 25, 2024 | 
pharmaceuticalonline.com | Brian Ball |Nikka Densok USA |Tim Russell
Finding a CDMO to support your small molecule API and high potent API (HPAPI) program with the right expertise, experience, and state-of-the-art facilities can be challenging.
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Jun 28, 2024 | 
pharmaceuticalonline.com | Keith Dodson |Brian Ball |Nikka Densok USA
The Business Value Of Connectivity For Product Inspection EquipmentRealize the value of connectivity, and more specifically, the value of the information provided by checkweighing, metal detection, vision inspection, and x-ray inspection.
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May 17, 2024 | 
pharmaceuticalonline.com | Tim Sandle |Brian Ball |Nikka Densok USA
Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more. 6 Reasons To Consider HVLD Vs. Vacuum Decay For Pharma ProductsHere, two of the more common methods for container closure integrity testing, high voltage leak detection (HVLD) and vacuum decay, are compared.
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Apr 9, 2024 | 
pharmaceuticalonline.com | Kate Coleman |Mike Ulman |Brian Svaton |Nikka Densok USA
There are important considerations that architects and engineers can miss if they don't include the quality perspective. It's better to involve quality at the outset rather than discover omissions when it's too late. Five Best Practices To Ensure Quality Active Pharmaceutical IngredientsIt is important to develop robust, reliable processes to safeguard APIs. Explore the best practices to provide patients with the highest quality treatment that meets their therapeutic requirements.
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Feb 22, 2024 | 
pharmaceuticalonline.com | Mark Witcher |Brian Ball |Nikka Densok USA |Raul P. Lima
This overview article takes a look at each product development stage for biopharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers. 6 Reasons To Consider HVLD Vs. Vacuum Decay For Pharma ProductsHere, we compare two of the more common methods for container closure integrity testing: high voltage leak detection (HVLD) and vacuum decay.
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Dec 12, 2023 | 
pharmaceuticalonline.com | Peter H. Calcott |Brandon Cole |Brian Svaton |Nikka Densok USA
In October, the FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating its remote evaluations program, the logistics of its implementation, and what they expect of the industry. The public comment period ends on December 26.
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Oct 6, 2023 | 
pharmaceuticalonline.com | Fran DeGrazio |Brian Svaton |Nikka Densok USA |Josh Russell
The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.
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May 19, 2023 | 
pharmaceuticalonline.com | Nikka Densok USA
HVLD, a sensitive, non-destructive technology to test container closure integrity in a variety of liquid-filled pharmaceutical and medical containers including glass vials and ampoules, IV-bags, Blow Fill Seal bottles and cards and pre-filled syringes.
