Change Control - The Achilles Heel of cGMP Compliance

The last few years have seen an increase in product recalls. For this and other reasons, 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 and subjected to greater scrutiny. Failure to comply will result in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. A key area for maintaining cGMP compliance is Change Control. Yet it often is a company’s weakest link in compliance. Why so? FDA expectations? How are successful companies meeting this challenge. Tools that need to be put in place or enhanced. Getting personnel buy-in. Getting senior management buy-in. Supplier buy-in.

Areas Covered in the Session:

• Change Control - what it is; what it is not
• Areas impacted by Change Control
• Regulatory / FDA 483 "Hot Buttons"
• Design control
• Document Control
• Identifying changes
• Preventing negative changes
• Maintain a 'state of control'
• Business needs and obtaining 'bur-in'

• Senior management, project leaders, internal / external consultants
• Mid-level management and supervisory personnel
• Corporate and site coordinators
• Regulatory affairs
• Quality systems personnel / QAE
• Document Control
• R&D and engineering staff
• Purchasing personnel
• New product development personnel