Description
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 implementation. This training will also enhance understanding and be beneficial to persons who work in product development and Technology transfer, regulatory affairs, pharmaceutical manufacturers, production engineering, site engineering, project engineering, Quality Operations, facility support services etc.
LEARNING OBJECTIVES
At the conclusion of this training, participants will be able to:
- Understand the principals of SFDA GMP guidelines.
- Describe the Pharmaceutical Quality System concept, objectives and state of control.
- Understand the life-cycle stages and Management responsibility.
- Describe the prerequisite for the pharmaceutical quality system.
- Understand the principles of developing, designing and implementing the Pharmaceutical Quality System at Oral Solid manufacturing facility.
KEY TOPICS
- Pharmaceutical Quality System (PQS)
- PQS- GMP for Medicinal Products
- Personnel
- Premises and Equipment
- Production – Oral Solid Dosage Form
- Case studies and Best practices
WHO WILL ATTEND
Professionals working in:
- Production – OSD
- Pharma Regulatory Affairs
- Product Development
- Production Engineers
- Quality Assurance
- Pharmacist
- Compliance
