|
|
|
By Ajay Pazhayattil and Marzena Ingram | These authors undertook a meticulous analysis of FDA drug facility inspection data spanning from July 2021 through May 2023. The resultant trend insights provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities. |
|
|
|
By Michael Rowe, director, DSCSA/Serialization Services, Two Labs | Serialized data exchange, enhanced verification, and tracing, oh my! Many companies are still unprepared for full DSCSA implementation in November. Is your company one of them? Here are the important actions to take now. |
|
|
|
By Anna Lukyanova, COO, Arriello | FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management. We expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short. |
|
|
|
|
| Kick It Off Right: A Successful Cell Bank Manufacture | Webinar | MilliporeSigma Biosafety Testing Services | Gain insight into the best practices for cell bank manufacturing, how to get the most out of your cell bank, the future of closed processing in line with Annex 1, and more. |
|
|
|
|
|
|
|
|
|
|
|
LIFE SCIENCE LEADER MAGAZINE |
|
|
|
Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business. |
|
|
