The Managing Your FDA Inspection: Before, During and After 2017 is a conference that covers topics such as:
- FDA`s annual inspection work plan
- FDA legal authority to inspect
- Over firm`s (Scientific/clinical studies, Premarket requirements, Postmarket requirements)
- Over products
- Recall procedures (What FDA expects from you.)
- FDA Center(s) Management
- FDA Field Office Management
- The firm`s job
- Inspection Procedures
- FDA Training
- FDA inspection Manuals
- Refusals
- Documenting violations
- Human factors
- Responding to a 483
- Inspectional observations (Form FDA-483)
- Recall procedures (What FDA expects from you.)
- FDA Center(s) Management
- FDA Field Office Management
- The firm`s job
- Responding to a Warning Letter
- Follow up inspections
- FDA enforcement actions
- Foreign Inspections
The Managing Your FDA Inspection: Before, During and After 2017 brings together:
- Quality Assurance Managers
- Regulatory Affairs Directors
- Manufacturing Directors and Managers
- Quality Control Managers
- Venture Capitalists
- Product Risk Managers