The Center for Professional Innovation & Education, Los Angeles, CA USA
1 - 2 February, 2018
Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)If you didn't write it down, it didn't happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don't tell you how. Based on industry best practices, this course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls. This course also addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant. Who Should AttendPharma, medical device, and biotech professionals who manage documents for all therapeutic product development and marketing activities (including pre-clinical, clinical, QA, and regulatory functions) should attend. This two-day course is also valuable for QA auditors who need to understand what constitutes sound documentation and documentation management.
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Invited Speakers:
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Kay Monroe Kay MonroeSpecialties: Quality, ManagementKay Monroe is Acting Executive Director of Zagaya. This non-profit – specializing in Malaria – works to bring innovative technologies to the problems of global health in the developing world. Ms. Monroe has spent over 25 years with biotechnology and pharmaceutical companies around the world; working on global project teams from Research through Phase IV and introducing Project Management Offices into several companies. She has extensive experience in product lifecycles and the creation of submission documents. In addition, she has sourced both items and processes for pharmaceuticals, biologics and devices. Ms. Monroe has held positions as Vice President of Operations, Project Management and Quality Assurance in companies such as Lundbeck, Synarc and Genentech. She has extensive experience in the start-up environment with such companies as Cerus, Dynavax and Amyris. Ms. Monroe received her Bachelors of Science in Animal Science from UC Davis and her MBA from Golden Gate University. |
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