Karissa joined NAMSA in 2016 following a career in industry which included stints at both Baxter and Genzyme in roles in Quality Assurance and Laboratory Operations. In her role at NAMSA, Karissa works with device manufacturers to develop and validate reprocessing instructions for reusable devices. In addition, she works with medical device manufacturers in other areas of Microbiology and Sterility Assurance such as development of endotoxin testing plans, packaging and shelf-life validations, bioburden test plans and other technical support for microbiology topics.

CORE COMPETENCIES

• Develops and maintains Sponsor Quality Management Systems (QMS)
• Assists with FDA inspections, including inspection and establishment inspections, Center for Drug Evaluation and Research (CDER) and Centers for Biologics Evaluation and Research (CBER)

• Develops SOPs for Quality Systems, aseptic processing and environmental monitoring
• Oversees approval of eCTD Submissions for NDA/ ANDA / BLA
• Manages critical utilities start-up and validation (water systems, compressed air, HVAC)
• Sets-up and maintains environmental monitoring programs
• Manages media fill and aseptic processing of pharmaceuticals
• Oversees new facility start-up and validation (aseptic fill, microbiology, biochemistry)
• Preparation and Validation of Biological Indicators (USP <55> and ISO 11138)
• Sterility Test and Bacteriostasis Fungistasis (USP <71>)
• Bacterial Endotoxins Testing (USP <85>)
• Develops Instructions for Use (IFU) and validation of reprocessing instructions for reusable medical devices

RECENT PROJECTS

• Worked with a device manufacturer to answer U.S. Food and Drug Administration (FDA) questions regarding reprocessing, resulting in successful validation of an updated manual cleaning and disinfection processes (FDA approval)
• Successfully generated technical documentation to support reduction of Bacterial Endotoxin Testing for a specialty device with approval of the approach from the FDA
• Performed onsite support for ongoing investigations of microbial contamination to determine the root cause and suggest preventative measures to limit future contamination
• Provided a full-day training for set-up, validation and ongoing evaluation of a medical device manufacturing Environmental Monitoring Program