The process to bring a drug to the commercial market involves a validation life cycle, which includes product and process design, facility and equipment qualification, process and product validation studies, and continuing evaluation. This course will provide an overview of the process, and suggest approaches that may be considered.
Why Should You Attend
To learn the required parts of a drug’s validation life cycle, and ways to satisfy the requirements of each component.
- Understand what must be accomplished during EQ, IQ/OQ, PQ, and PV
- Learn methods to assure smooth transfer from lab to production equipment
- Learn approaches to establish correlation between development and production freeze dryers
- Understand challenges of moving from non-controlled to GMP environments
- Learn a QbD approach to product and process design and management
- Learn post-validation approach for managing deviations during production activities
- Dryer correlation
- Tech transfer
- Quality by Design
- Deviation management
Who Will Benefit
- Professionals in Quality Control
- Quality Assurance
- R&D Groups
- Pilot Plant Operators
- Chemical Engineers
- Production Supervisors
- Equipment Maintenance
- Mechanical Engineers
The course will also benefit those in other departments who find lyophilization among their responsibilities.