Understanding CA State Licensure Requirements December 2, 2008

This one day presentation and discussion will outline the expectations of California State FDA requirements for licensure, regulatory aspects of manufacturing drugs and devices, and quality systems requirements for passing California State Inspections. The speakers include ex-CA State Investigator, Regulatory and Quality Experts. There will be panel discussions to address attendee questions.

Understanding CA State Licensure Requirements
This presentation will help start-up companies understand state Licensure requirements, how to apply, and what to expect during inspection.
* Understand the relationship between FDA and the State
* What do State investigators do when on site
* Learn about processes State Investigators use when on-site inspections
* An insight into the state powers and authorities
* What are the actions State Investigators take if the company is deficient
* How can you get them to accept your compliance plans
* What are the consequences of delaying or not even applying for licensure
* What happens if you move?

Regulatory Requirements for Drugs and Devices
This overview presentation is intended to provide a general introduction to regulatory requirements for the development of drugs and devices. The attendee will get a high-level view of the key items involved in the process of complying with the regulations.
Devices
* Device definition and classification
* Types of device submissions
* QSR GMP compliance
* Overview of Agency interactions
* Review and approval process
* Post-marketing requirements
Drugs
* Drug development process - Phases
* Types of submissions at the different Phases
* cGMP compliance
* Overview of Agency interactions
* Review and approval process
* Post-marketing requirements

$950.00.

Official Website: http://www.microrite.com/dec_2008.pdf