ComplianceOnline

Expert Profile


Casper Uldriks
Former Associate Center Director, CDRH

Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an associate center director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. Mr. Uldriks understands how FDA thinks, how it operates, and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. His professional credentials include: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

Trainings by Expert

FDA's Ambitious Regulation of Social Media
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , Drug Marketing Compliance , Marketing and Promotion , Documentation and IT , Laboratory , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations

FDA's Medical Device Software Regulation
Category: Medical Devices , Risk Management , All FDA Regulated Industry , GXP Medical Devices , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Risk Management & Controls , All FDA Regulated Functions , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

Moving FDA Boundaries for Direct-to-Consumer Advertising
Category: Drugs and Chemicals (Pharma) , Medical Devices , All FDA Regulated Industry , Drug Marketing Compliance , Marketing and Promotion , Supply Chain and Manufacturing , Drugs Regulations , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

FDA Import Alert - 2017
Category: Drugs and Chemicals (Pharma) , Medical Devices , Trade and Logistics Compliance , All FDA Regulated Industry , Supply Chain and Manufacturing , Regulatory Requirements , Documentation & Recordkeeping , Supply Chain , Import/Export Systems , Trade & Logistics Regulations , Drugs Regulations , Documentation and Policy Management , Trade Compliance Documentations , Supply chain & Procurement , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management