Analytical Quality by Design, Life Cycle Management, and Method Control.

Analytical methods are utilized throughout the biopharmaceutical and vaccines industries to conduct research and development, and to help control manufacturing inputs and outputs. These analytical methods should continuously provide quality data to support decisions while managing the remaining of risk and uncertainty. Analytical quality by design (AQbD) can provide a systematic framework to achieve a continuously validated, robust assay as well as life cycle management.

Nontransvenous Cardiovascular Implantable Electronic Device Technology-A Review for the Anesthesiologist.

There has been a recent shift in bradycardia pacing and defibrillation therapy to leadless pacemakers and extrathoracic cardioverter-defibrillator technology due to complications associated with transvenous devices. These innovations have implications for anesthesia care, as these novel devices have design and functionality features different from transvenous devices. Current perioperative guidelines do not address management of leadless pacemakers and the subcutaneous implantable cardioverter-defibrillator, although implantation rates are increasing globally.