cGMP Water Systems – Are You Ready for the FDA Inspection?

All Pharmaceutical products and R & D require USP and FDA Pharmaceutical Grades of Water. It is used as an ingredient, cleaning manufacturing equipment, a key ingredient for Quality tests and sold in containers. If a company cannot meet, maintain and demonstrate the Water Standards legally required, they cannot sell their products. Pharmaceutical employees are required to be knowledgeable about Pharma Water requirements to assure they produce safe products.

The knowledge includes the principles of producing and maintaining the Pharmaceutical grades of water required to established minimal standards and storing it in quantities to meet production needs, distributing it to several points of use while maintaining the minimal chemical and microbial requirements. All Pharma Water Systems will be inspected by the FDA to determine if ALL STANDADS required are met. Pharma employees should be prepared to discuss the Water Systems with the FDA Inspectors.

Areas Covered in the Session :

• What is a 505(b)(2) NDA
• What products qualify for submission under 505(b)(2)
• Examples of data and information that may be referenced
• Requirements for studies to be conducted
• Submission content requirements
• Limitations to and benefits of a 505(b)(2)

Who Should Attend:

• Regulatory Affairs Departments
• Quality Departments
• Manufacturing Departments
• Engineering Departments
• Technical Operations Departments
• Supply Chain Departments

Course Director: PETER VISHTON

Peter is an Independent Pharmaceutical Water Systems Consultant working with several companies. He has 25 years of experience in the Pharmaceutical area which includes 10 years with Pharmaceutical Water Systems. 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 and 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. Peter completed his Bachelor’s Degree and his Master of Environmental Management Degree from Drexel University. He is an active ISPE member that participates in current and new technology publications and forums assuring current knowledge of industry practices in GMP Manufacturing, Clean Utilities, Quality and FDA guidance. He has been a contributing author on all the ISPE Communities of Practice Publications for GMP Pharmaceutical Water, Steam and Compressed Gasses where he worked with Industry Experts.