Workshop2: Principles for Successful GXP Inspections: A Hands-On Interactive Approach based on FDA, WHO and Industry Experiences
May 11 2014 8:30AM - May 11 2014 5:30PM | Shanghai International Convention Center
No. 2727, Riverside Avenue
Preparing for GMP, GLP, GCP, PV/Risk Management inspections by stringent regulatory authorities, including from the FDA and the WHO, is critical for meeting quality and safety standards. This workshop will allow participants to learn from instructors with backgrounds from regulatory agencies and industry, and with first-hand experience in conducting inspections and undergoing inspections. Both didactic and interactive learning will be provided.
Who Should Attend
Regulatory and compliance personnel from industry, regulatory authorities, and other interested parties in GxP and compliance.
- Must have at least 5 years of industry or regulatory experience
- Must have basic familiarity with GxP requirements
- Fluent in English
- Understand the fundamental principles for success for GxP compliance and inspection
- Experience learning through role playing, scenario discussion and review of mock inspection materials to allow students to identify opportunities to improve and correct processes, procedures, and measures of compliance
- Utilize perspectives on overcoming challenging situations to improve GxP compliance
- Learn about regulatory expectations on industry from FDA alumni, inspectors on behalf of WHO, and industry experts