This Pharmaceutical training will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing. This seminar is designed to provide a thorough understanding of the principles applied to the design, qualification and operation of cleanrooms.
The testing procedures and the regulatory requirements with regard to cleanrooms qualification and certification will be discussed. This course will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing.
The testing procedures and the regulatory requirements with regard to cleanrooms qualification and certification will be discussed. This course will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing.
Areas Covered in the seminar:
- Design, qualification and operation of cleanrooms
- The testing procedures
- ISO 14644 series standards
- FDA’s 2004 guidance document for aseptic processing
Who Will Benefit:
Personnel working in sterile pharmaceutical manufacturing facilities and are responsible and involved in the activities, such as the cleanrooms qualification, maintenance, operation and monitoring at an ongoing basis.- Validation staff
- Engineering Staff
- Microbiologist
- Production management and staff directly involved in cleanroom operation
- QA staff
- Team members of Quality Management System (QMS)
- Contractors
- Consultants
Course Provider
Nazia Dar,
