How to Survive the FDA Design Control Inspection: Common Problems and Risk mitigation

This webinar will explain Design Control, what it means, and how to incorporate it into the design and construction of a new facility or a renovation.

Why Should You Attend:

It is never good to be unprepared. This is especially true when you are not prepared to respond to an FDA investigator. During the first FDA inspection of a new manufacturing facility, a part of the inspection will involve something called 'Design Control'. There is very little written about this subject and most of the design firms do not spend time on this.

Areas Covered in the Seminar:

• Product Flow.
• People Flow.
• Air Flow.
• Air Quality Zones.
• Architectural Finishes.
• Water Qualities Required; treatment, storage, and distribution.
• Gasses required; treatment, storage, and distribution.
• HVAC requirements & design.
• Steam requirements; treatment and distribution.

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel:

• Engineering
• Manufacturing
• Quality assurance
• Regulatory Affairs
• Validation