OR WAIT null SECS
It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
August 02, 2020
A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
Dissolution testing is an important aspect of drug development as it provides stability parameters and helps predict drug behavior in-vivo.
Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.
When in-person training may not be feasible, there are still opportunities to ensure employees receive the required training, says Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.
August 01, 2020
Contract service providers offer vital services to bio/pharma companies of all sizes. Establishing an effective working relationship and managing operations are key to avoiding compliance issues.
Hiring the right quality consultant can provide expertise and save costs.
Carcinogenic compounds have been found in a number of top-selling drugs, leading to recalls and bans. Preventing problems requires working closely with contract testing and development partners as well as API and other suppliers.
July 24, 2020
Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.
July 21, 2020
Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?
July 20, 2020
Industry should be seeking more information from FDA on how it will restart its current inspection program.