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cGMP Water Systems – How to Avoid Their Typical Emergencies & Problems
- Design of the Systems
- Manufacturing details of the equipment
- Installation of the Systems to GMP Standards
- Testing the Components and Systems
- Gathering the Data of the Systems to GMP Standards
- Commissioning
- Initial Operation Testing
- Validation
- Continued Operation
Overview of the webinar
Pharma cGMP Water Systems are very critical to the safe production of medicines for patients. Several Departments are required for continued High-Quality operations. These include Quality, Manufacturing, maintenance and Validation on a daily basis. This presentation will cover several elements of the details involved in the success of the operations and the satisfaction of the FDA.
Who should attend?
- All employees of pharmaceutical companies
- All employees of contract manufacturing companies for pharmaceuticals
- Anyone contemplating starting a pharmaceutical manufacturer
Why should you attend?
- This presentation is designed for pharmaceutical and biopharmaceutical professional Teams to provide the knowledge that will keep their cGMP Water Systems in operation for products production. Learning the fundamentals of Systems installation, qualification and Validation is essential.
- This presentation will also help non-engineering personnel understand the fundamentals of day-to-day systems operations, as well as provide necessary basics of criticality of these systems to the quality of pharmaceutical and biopharmaceutical processes and products.
- Additional training of the most critical points to consider will improve the operation, optimization, qualification, Validation standards and reliability of the Systems.
Faculty - Mr.Peter T. Vishton, P.E.
Peter is an Independent Pharmaceutical Water Systems Consultant working with several Pharmaceuticals. He completed his Bachelor’s and his Master of Environmental Management from Drexel University. He has 25 plus years of experience in the Pharmaceutical area which includes 15 years with Pharmaceutical Water Systems. He has been involved in numerous Water Systems and gained the knowledge and ability to resolve problems quickly.
Peter’s experience includes being a member of GMP Teams to Design / Construct / Start Up /Commission and Qualify new or expanded pharmaceutical facilities. These were GMP Production spaces, Manufacturing Equipment, Utilities and their Control Systems. Among the assignments were Parenterals, Biologics, OSD, their Pharmaceutical production rooms and equipment. The utilities and facilities Validation documentation were included and lead to the completion of Validation and initial production batches