Change Control - Key to Successful cGMP Compliance 2015

Topics

• Areas impacted by Change Control
• Change Control - what it is; what it is not
• Design Control and Filing a New 510(k)
• Regulatory / FDA 483 "Hot Buttons"
• Identifying Changes
• Document Control
• Give the FDA It`s Desired `State of Control`
• Preventing Negative Changes and Entropy
• Business Needs and Obtaining Stakeholder `Buy-In`

Who should Attend

• QA
• Senior management in Drugs, Devices, Biologics, Dietary Supplements
• R&D
• RA
• Production
• Engineering
• Consultants
• Operations