As a quality engineer, a lot of us have had a project leader ask us to sign off on a project when the data has too many outliers. How do you navigate that situation?
In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.
In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.
In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, Manufacture of Sterile Medicinal Products.
Transformative Shifts In Medical Device Package Quality Testing
While the medical device industry continues to evolve to accommodate lifesaving therapies, advancements in deterministic testing technologies ensure medical device packaging integrity and sterile delivery to the patient.
The article discusses recent advancements in piezo mechanics that are being utilized to improve precision and effectiveness in eye surgery procedures.
Boomerang projects in micro molding, where customers' projects return to the manufacturer for rework or modifications, present challenges due to design changes, quality issues, material-related challenges, and poor communication.
For purposes of this study, three lateral flow tests were selected. Explore the effects of different surfactants on the performance of UniSart® diagnostic membranes.
Explore the Octet® family of BLI systems that are used throughout biotherapeutic discovery, development, manufacturing, and QC workflows to simplify and streamline measurement of process and product attributes.
MED DEVICE ONLINE CONTENT COLLECTIONS
Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.More Content Collections
- Freudenberg Medical Utilizes VR Training In Catheter Manufacturing
- Qosina Releases New 2023 Bioprocess Single-Use Components Catalog
- Accumold Once Again A Prominent Presence At MD&M East
- Canon Medical Components, Digital Radiography (DR), Announces High Performance, Affordable, Wireless CXDI-Pro Series Flat Panel Detector Systems
- Sustainable Technologies: Reprocessing Medical Devices To Reduce Healthcare’s Carbon Footprint And Drive Cost Savings
- Viridian Therapeutics Announces Partnership With Drug Delivery Innovator Enable Injections
- Cardinal Health Executives Visit Capitol Hill, Engage With Members Of Congress On Key Legislative Priorities
- Qosina Introduces New Genderless AseptiQuik® W Series Connectors For Large-Volume, High-Flow Production Environments