Implementing the Best Practices for FDA Inspection Preparation and Management 2014
07 Oct 2014
Webinar
Description
Topics
Definitions
Statutes and Regulations
Regulatory Requirements for Compliance
FDA Manuals
Inspection Types and Categories
FDA BIMO Inspection: Scope and Depth
Inspection Process
Inspection Classification
How to Answer Questions
Hosting an FDA Inspection
Dos and Don’ts Before, During and After FDA Inspection
FDA Forms 482 and 483
Misconception and Frequent Mistakes
Responding to 483: Best Practices
Improving Awareness and Exercising Sound Judgment
Enforcement Cases
Transparency, Accountability and Integrity
Good Business and Employment Practices
Practical, Actionable and Sustainable Recommendations: Best Practices
Who should Attend
VPs
CEOs
Attorneys
Compliance Officers
Clinical Affairs
Regulatory Affairs
R&D
Quality Assurance
Contractors/Subcontractors
Consultants
Anyone Interested in the FDA (BIMO) Inspection Process
Past Events
Implementing the Best Practices for FDA Inspection Preparation and Management 2014 - 07 Oct 2014, Webinar (47301)
Important
Please, check "Implementing the Best Practices for FDA Inspection Preparation and Management" official website for possible changes, before making any traveling arrangements
Event Categories
Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Medical laboratories, Pharma
