GMP for Quality Control Laboratories and FDA Audit Preparation 2018

Topics

• 21 CFR part 11 and EU Annex 11
• FDA, EU, WHO, PIC/S, India GLP Regulations
• Validation Master Plan
• FDA 483s and Warning Letters Observations
• Equipment Calibration and Qualification
• SOPs and Best Practices
• Analytical Method Validation
• Systems Validation
• Laboratory Data integrity
• OOS, OOT and OOC
• FDA Audit Preparation

Who should Attend

Attendees with responsibilities in:

• Quality Control
• DEPARTMENTS:
• Research and Development
• Quality Assurance & Testing
• Manufacturing
• Laboratory
• Regulatory Compliance
• Production
• Preclinical Development
• Validation
• Training Departments
• Documentation