Course Description

GXP Foundations

Online On Demand

Course Offering 1903908OL2842A
Course ID 2842

In-Person Course

Who Should Attend?
This course is intended for professionals within all branches of the regulated medical product sector, including Pharmaceuticals, Biologics, Diagnostics and Medical Device industries. Personnel from entry-level to executive performing in the following positions will find the course valuable:

Clinical: Research Associates, Scientists, Study and Site Monitors, Data Specialists, Trial and Operations Managers

Preclinical: Study Scientists, Technicians and Managers

Quality: Engineers, Associates and Managers

Manufacturing: Technicians, Assembly, Engineers, and Supervisors; Shipping/Receiving

Engineering/R&D: Engineers at all levels, Scientists at all levels

Executive Leadership, especially if you are new to medical product development; are in need of a GXP refresher; or are leading an early stage company and want to establish a quality-oriented corporate culture

Course Description
GXP are a set of regulations and guidelines that together embody best practices for several key elements of medical product development. Because the regulatory landscape is complex and medical product innovations are both unique and diverse, it can be difficult for sponsors to develop a framework for product development and marketing that is both acceptable to regulators and tailored to accommodate the unique requirements of the product itself. In addition to fostering compliance and regulatory product approval, GXP can be adopted as a philosophy to drive a healthy and productive corporate culture from company inception to exit.

This 90-minute, accredited training will address key components of GXP and its implementation.

Course Director
Lucia Mokres, Consultant to the Biotechnology Industry

Dr. Lucia Mokres is a Biotechnology Entrepreneurial Consultant based in the Bay Area, specializing in helping early stage companies with novel technology gain traction and develop an investable technology and business model, and helping later stage companies work through regulatory and clinical challenges. Prior to establishing her consultancy, she was the Chief Medical Officer of EpiBiome, Inc., a precision microbiome engineering company that employs a genomics approach to profiling complex microbial communities, and deploys bacterial viruses to selectively eliminate problematic bacteria without the use of small-molecule antibiotics in humans, animals, and plants. In this role she leveraged her clinical, research, and industry background to provide medical oversight and strategic direction for all clinical development activities, defined regulatory strategy, supported marketing and business development activities, and served as the medical point of contact for external stakeholders. Prior to joining EpiBiome, she served as a Principal Clinical Scientist and medical advisor at Evalve (acquired in 2010 by Abbott Vascular), supporting medical safety and development of the MitraClip, a minimally invasive device used to reduce mitral regurgitation without the need for open heart surgery. Prior to joining Evalve, she served as a Program Specialist at Hantel Technologies, a contract medical device engineering and manufacturing firm, serving as a liaison between clients and internal departments, and managing timelines and budgets for projects ranging from single person startups to Fortune 500 companies. She completed her postdoctoral fellowship at Stanford University School of Medicine in the Department of Pediatrics.

In her spare time, she instructs a Stanford Medical School elective, which provides training for medical students, nurses, physicians and other healthcare professionals in bedside manner, teamwork, leadership, and nonverbal communication skills; serves on the Association for Women in Science STEM to Market Advisory Board; is a member of the AWIS Palo Alto Mentoring Committee; and mentors other early stage companies through the Springboard Enterprises and California Life Sciences Institute advisory programs.

She completed her postdoctoral fellowship at Stanford University School of Medicine in the Department of Pediatrics, and graduated Cum Laude with a Doctorate in Veterinary Medicine from Colorado State University College of Veterinary Medicine and Biomedical Sciences.