Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges
Flexible bag systems for large volume parenterals (LVPs) are subject to stringent regulatory oversight for extractables and...
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Product Safety Future State of Sterility Assurance and the Role of Terminal Sterilization
Sterilization is a critical step in the pharmaceutical drug development process to ensure overall safety. Regulations are...
Design of Protocols for Biologics
In this episode, host Brandon Miller is joined by Steve Lynn, Executive VP of Pharmaceuticals, and Walter...
Establishing Maximum Acceptable Dose for Medical Devices in Radiation Sterilization
Medical device manufacturers using ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes must establish the...
Future Trends To Control Risks From Extractables and Leachables
Prior to 2018, ophthalmic drug products (ODPs) and parenteral drug products (PDPs) underwent similar processes for Extractables...
Data Integrity and Quality Culture During the Pandemic
In this episode, host Brandon Miller is joined by Steven Lynn, Executive Vice President of Pharmaceuticals at...
Why is the Sterility of your Drug Product much more than just a Test of Sterility?
Ensuring sterility and sterility assurance is crucial in the pharmaceutical industry, as the lack of these can...
Key Elements of a Sterility Assurance Program
This webinar will delve into various aspects of a sterility assurance program for pharmaceutical products, emphasizing its...
Aging Facilities and In-Shoring Product to the US
In this episode, host Erika Porcelli is joined by Brendan McCrea, Regulatory Compliance Associates (RCA) Director of...
Pharma Packaging Considerations for Radiation Processing using Gamma and Electron Beam and Discussion on the New Container Closure Integrity Testing
This webinar is designed to enhance your foundational knowledge of pharmaceutical packaging, particularly focusing on its critical...