Depending upon the medical device, residual levels of processing agents and materials pose a potential toxicological risk to patients. Manufacturers of medical devices need to identify and properly control for contamination of the medical device from processing agents and materials.
A lot of companies are constantly undergoing merging acquisitions such as from Company “A” purchasing Company “B” running in parallel before Company “B” fully adheres to the QMS of Company “A”.
This discussion covers aseptic testing - a representative aseptic test procedure , along with consequences of test failures, test problems, and the role of management to get your operations up-to-speed.
Regulatory agencies such as the FDA stress the importance of periodically holding lessons learned discussions to review compliance in change control. Change control is a systematic approach to managing changes to a Procedure (SOP), Quality System Policy (QSP), process, product, service or system.
With a rapid growth of global interest in the cannabis industry and with the push towards legalization, it is important to understand the production process of cannabis from seed to sale. Building recognition and appreciation for the complexities of the cannabis plant and associated product manufacturing will help explain the cannabis industry and...
Data integrity issues can mask problems and failures which can be a result of deceptive practices such as data falsification. Data integrity issues normally are a result of inadequate processes, procedures and systems to ensure reliable and accurate data. The FDA considers any gap in data integrity as a risk to patient safety.