OVERVIEW

Understanding basics of GMP are essential skills for people working in pharmaceutical industry. This course will provide an explanation to SFDA GMP guidelines and how to prepare for inspection. This training will also enhance understanding and be beneficial to persons who work in scientific offices, regulatory affairs, pharmaceutical manufacturers, data management, basic research, project management and marketing, etc.

LEARNING OBJECTIVES

At the conclusion of this training, participants will be able to:

• Understand the principals of SFDA GMP guidelines.
• Describe the different types of GMP inspection.
• Understand The general GMP inspection components

KEY TOPICS

• GMP Legal Framework
• Type of GMP Inspection
• Quality Management
• Personnel
• Premises and Equipment
• Documentation
• Production
• Quality Control
• Contract Manufacture and Analysis
• Complaints and Product Recall
• Self Inspection

WHO WILL ATTEND

Professionals working in:

• Pharma Regulatory Affairs
• Fresh Graduate
• Scientific Office Managers
• Regulatory Authorities.
• Pharmaceutical manufacturers
• Pharmacist
• CRO staff