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Fireside chat with California Drug and Medical Device Chief
July 15, 2020 @ 12:00 pm - 1:30 pm$10 – $25
Fireside chat with California Drug and Medical Device Compliance Chief:
Keeping Informed & Working Together
July 15, 2020
12:00 pm – 1:30 pm
Speaker: Harlan Loui, Section Chief , Drug & Medical Device Compliance & Enforcement Section, California Department of Public Health
Program Managers: Tommi Papson, OCRA President-Elect, President Regulatory Consultants Group
Luis Jimenez, OCRA President, Chem E, MBA, VP of Bis Dev Brandwood CKC
What’s New? Updates on the role of Calif Department of Public Health- Food and Drug Branch (CDPH-FDB) in regulating the drug and device industry (i.e. licensing requirements, inspections, etc.). Discussion about the Interactions and regulatory partners, joint inspections, with United States Food and Drug Administration (FDA), State Attorney General, District Attorneys and other regulatory agencies.
The discussion will include:
- Introduction to the California Drug and Medical Device Compliance Enforcement Section
- Regulatory Intelligence Updates
- Collaboration and partnerships with FDA
- Recent enforcement trends
- California’s response to the COVID-19 Pandemic
- Keeping informed & working together
The discussion will be a fireside chat-style forum with Mr. Loui with a panel Q&A at the end.
OCRA Members: $25
Non-Members: $100, includes 1-year OCRA membership (Purchase Membership First)
Government and Student Members: $10, with student/government ID
Harlan Loui is the Section Chief of the Drug and Medical Device Compliance and Enforcement Section with the California Department of Public Health, Food and Drug Branch. Mr. Loui is in charge of statewide operations for the section, which includes the licensing of drug and medical device manufacturers, and home medical device retailers, and oversees field operations which includes inspections, investigations, and enforcement activities. Mr. Loui earned his Bachelor of Science Degree in Biological Sciences from the University of California, Davis and worked for a number of years in the environmental testing industry. He later further his education in Criminal Justice and changed his career to work as an Inspector with the California Department of Consumer Affairs. Shortly after, Mr. Loui began his professional career in law enforcement with the Food and Drug Branch as an Investigator and has had the opportunity to work in the food, drug and medical device programs, which included regulatory inspections; health fraud investigations; and other law enforcement related activities. Some of his other past duties included being the department’s law enforcement training manager, and instructor in several disciplines.
OCRA’s non-profit Federal Tax ID# 33-0630455
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Thanks to Benjamin DeYoung for sharing their work on Unsplash.