Setting Up and Running a Tougher Supplier Audit Program

The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based.

Most Warning Letters will not have an initial judicial review, resulting in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. A key area gaining attention is a company’s suppliers, for both services and products / components.  Why needed? FDA expectations? How are successful companies meeting this challenge. Tools that need to be put in place or enhanced. Getting supplier buy-in. Coping with "rogue" suppliers.

Areas Covered in the Session:

• Regulatory "Hot Buttons"
• Classify suppliers
  
• Supplier requirements by "classification"
  
• The site audit
  
• Types of remote audits
  
• Maintaining the relationship

• Senior Management, Project Leaders, Internal / External Consultants
  
• Mid-level management and supervisory personnel
  
• Corporate and site coordinators
  
• Regulatory Affairs
  
• Quality systems personnel / QAE
  
• R&D and engineering staff
  
• Purchasing personnel
  
• New product development personnel