Business of Biotech features a candid conversation on building your pitch with Leslie Williams, founder and CEO of ImmusanT. Leslie discusses the art of the deal and why a combination of nuance and humanity in your presentation are as important as the slides in your deck.
Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.
For medical device manufacturers and FDA/ISO registered facilities, the integrity of quality systems is critical. Ensuring the quality system is suitable, efficient, and effective for business needs and customers is a key focus.
White Paper |
By Bruce Anneaux, Ph.D., and James Lindsey III, MS,Zeus
Treating CAD with bioresorbable vascular scaffolds (BRS) is considered by many to be the “next revolution” in endovascular therapy. This paper presents the basics of BRS technology, its processing and manufacturing challenges, and its advantages in use with polymer technologies.
Today’s version of the medical procedure kit comprises stackable, efficient, sterile, and identifiable trays or pouches stocked with essential equipment for specific surgeries, tests, and examinations.