Description
OVERVIEW
Understanding the Pharmaceutical Quality System is an essential skills for people working in pharmaceutical manufacturing industry. This course will provide an overview of the pharmaceutical quality system for sterile medicinal product as specified in SFDA GMP guidelines and prepare for implementation. This one day course is designed to increase their knowledge in contamination control strategy, specific technologies and will provide a comprehensive, yet practical assessment of the regulations.
This training will also enhance understanding and beneficial to persons who work in product development and Technology transfer, regulatory compliance, pharmaceutical manufacturers, production engineering, site engineering, Quality Operations etc.
LEARNING OBJECTIVES
At the conclusion of this training, participants will be able to:
- Understand the principals of Production Technology for sterile medicinal products
- Understand the contamination control strategy
- Describe the premises for a clean area and clean area monitoring
- Understand the principles of specific technology for the sterile medicinal product manufacturing
KEY TOPICS
- Pharmaceutical Quality System (PQS)
- Personnel
- Equipment
- Premises clean area and monitoring
- Production Technology
- Specific Technologies
- Processing (Production-Sterilization)
WHO WILL ATTEND
Professionals working in:
- Production – OSD
- Pharma Regulatory Affairs
- Product Development
- Production Engineers
- Quality Assurance
- Pharmacist
- Compliance
