March 15, 2022
Quality
2022 eBook
1
Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.
March 15, 2022
Outsourcing
2022 eBook
1
Why critical thinking must be applied before technology to ensure regulatory compliance.
March 15, 2022
Quality
2022 eBook
1
Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape.
March 15, 2022
Analytics
2022 eBook
1
CAR-T cell therapy development is a complex process that requires standardization.
March 15, 2022
Quality/Regulations
2022 eBook
1
As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.
March 15, 2022
Quality/Regulations
2022 eBook
1
Disruptions in the bio/pharmaceutical supply chain can have serious impacts on the quality and availability of life-saving medicines.
March 15, 2022
Quality/Regulations
2022 eBook
1
Interoperability by 2023 depends on data standardization and systems compatibility between trading partners.
March 15, 2022
Quality/Regulations
2022 eBook
1
A consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines.
March 15, 2022
Quality/Regulations
2022 eBook
1
This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.