GMP Compliance for Quality Control and Contract Laboratories 2017

Topics

• The company’s quality plan or laboratory compliance master plan
• Regulatory background and GMP requirements for quality control and contract laboratories
• How to develop inspection ready documentation
• The difference between GMP and non-GMP laboratories
• How to avoid and/or respond to the FDA inspectional observations and warning letters

Who should Attend

Personnel in FDA regulated laboratories, including:

• QA managers and personnel
• Analysts and lab managers
• Regulatory affairs
• Validation specialists
• Human resources (HR) managers and staff
• IT professionals
• Documentation department
• Training departments
• Consultants& teachers