Principles of Sterile Manufacturing
Instructor:
James Harris(PhD)
Product ID: 700991
- Duration: 60 Min
The manufacture of sterile medical products and medications requires all of the things demanded of non-sterile manufacturing plus a long list of additional procedures, techniques, and specialized facilities required to assure the enhanced cleanliness and sterility that is required of these very special products. A detailed treatment of this subject would take two or three days. To meet the time constraints of this presentation, we will limit the discussion to clean room design and operation - the basic concepts of sterile operation.
Areas Covered in the seminar:
- Clean Room design - materials of construction; air locks. Air showers, material flow, people movement, and air flow.
- Containment.
- Gowning.
- Sterile Procedure.
- Process control.
- Environmental control and monitoring.
- Assurance of sterility.
- Diofference between pharmaceutical & electronics.
Who Will Benefit:
This webinar in designed to provide the basic knowledge needed to create and operate a sterile manufacturing facility.
- Managers
- Supervisors
- Leaders
- Operators
- QA inspectors
- Scientists
- Auditors and researchers wor work in manufacturing
- Quality assurance/quality control
- Regulatory
- Research and development in the pharmaceutical and biologics industries as well as similar workers involved in the medical device and diagnostics industries.
James R. Harris, PhD held VP level management positions in several of the world’s largest pharmaceutical firms before forming a consulting organization that worked globally serving pharmaceutical and related industries in over 60 countries.
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