Pharmaceutical cGMP, Data Integrity and FDA Inspections – Current Challenges and Preparations 2016

Key Topics

• CGMP for APIsBuildings & Facilities, Equipment, Control of Components
• CGMP for Finished Pharmaceuticals
• Documentation, Change Control, Process Validation
• Production and Process Controls, Laboratory Controls
• Data Integrity
• Quality Protocols
• FDA Inspection Guides
• Electronic Records and Signatures
• Recent FDA Warning Letters
• Top 10 most common cited FDA Inspectional Observations (cGMP deficiencies)
• Indian Pharma and Challenges Ahead

Who should Attend

Attendees involved or interested in:

• Quality Control & Quality Assurance
• A must attend seminar for professionals in Pharmaceutical development and quality control companies, Manufacturers of drug substances (APIs), Finished Products, Contract laboratories and Clinical Research Organizations
• Regulatory Compliance
• Research and Development Engineering
• Validation Production
• Manufacturing and Facilities
• Documentation Supply Chain and Logistics