There are eight types of water used in manufacturing drug products. And, it is of paramount importance to design, validate and control water systems used in the manufacture of drugs, biologics and medical devices.
This session is intended to discuss FDA requirements for water systems from a microbiological aspect for drugs, biologics and medical devices. In particular, it is intended to discuss microbial control, monitoring and validation of water systems.
This presentation will provide great opportunities for industry professionals to be better aware of and get more familiar with the FDA’s expectations for establishing water systems suitable for use in the manufacture of drugs, biologics and medical devices.
Areas Covered in the Session :
- Applicable Laws and Regulations
- Types of Medical Products
- Key Considerations for Designing a Water System
- Types of Water Used in the Manufacture of Drug Products
- Different Types of Water Required for Different Types of Products
- Water System Design: Acceptable Methods
- Types of Water Required for Inhalation, Ophthalmic or Parenteral Products, etc.
- What to Consider for Water System Validation
- Water System Validation
- Common Problems
- Microbial Control for Different Types of Water
- Acceptance Criteria
- Water Sampling
- PASS-IT Recommendations
Who Will Benefit:
- Regulatory Affairs Departments
- Clinical Affairs Departments
- Quality Assurance Departments
- Compliance Officers
- Radiation Safety Officers
- Laboratory Departments
- Research & Development Departments
- Any professional interested in this topic