Quality Culture at the Crossroads: Building a Culture of Quality for Increased Success
In this webinar, Susan Schniepp, distinguished fellow at Regulatory Compliance Associates®, will delve into effective approaches for...
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Sterility, Manufacturing and Regulatory Challenges in a Constantly Changing World of Biopharmaceuticals
The biopharmaceutical sector is experiencing rapid changes, transitioning from monoclonal antibodies to advanced therapies such as Cell...
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...
Upcoming Changes to Cleaning Validations for Reusable Medical Devices
For the past decade, AAMI TIR30 has served as a key guidance document for the cleaning validations...
Assessing the Safety of Extractables and Leachables for Drug Products: When and How?
In this insightful webinar, Kevin Breesch of Nelson Labs will address the significant challenges associated with toxicological-safety...
EO Sterilization: Considerations for Neonate Products and Medical Devices & ISO 10993-7
Ethylene oxide (EO) sterilized items are life-saving and critical devices that undergo sterilization in highly regulated environments,...
Extractables and leachables testing of a combination device: testing in between regulations for pharmaceutical products and medical devices
Extractables and leachables (E&L) testing of combination devices requires a specific study setup that differentiates from a...
Understanding the Power of the FDA Pre-Sub: Tips for a Successful Meeting
The submission process to the FDA can be a stressful and uncertain time for a medical device...
The Design and Qualification Process for a LVP Packaging System from a User Perspective
To meet the growing patient need for Large Volume Parenterals (LVP), increasingly complex packaging systems must be...
Bioburden Alert and Action Levels – Low Hanging Fruit for a FDA Citation
Most standards regarding bioburden and environmental testing emphasize the importance of establishing alert and action levels. These...