Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
Duration: 60 Minutes
This webinar will cover what is important in facility design from the FDA and regulatory standpoint. You will understand what FDA looks for during a facility inspection. You will be able to minimize possible design errors which are difficult and expensive to fix post-build. Understand what FDA looks for in reviewing the facility design and the flow patterns.
Objectives of the Presentation
Why Should you Attend
- Best design practices for pharmaceutical facilities
- Best design practices for biologics facilities
- Regulatory compliance for Pharma and biologics facilities design
- Flow patterns and cross contamination controls
- Design criteria for fixtures and finishes
- Examples of good design
- General specifications for different classification zones
- Examples of design specs for cleanrooms
This course explores some of the best practices of pharmaceutical and biologics facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements will be discussed and the reasoning behind them. Examples of floor plans and flows (people, product, etc.) will be examined and discussed. Specifics for fixtures, finishes, HVAC and other design aspects of cleanrooms will be discussed in terms of current practices and GMP requirements.
Examples of design choices for pressurization, flows and HVAC zones will be given along with their possible application. Design specifications for both open and closed systems will be discussed along with current standards.
Who will Benefit
The following professionals from the pharmaceutical and biologics industries will benefit from this training:
- Compliance Manager
- Facility Manager
- Validation Manager
- Regulatory Manager
- Design Team/Architects
- Building Contractors, Validation Engineers, Quality Engineers, Quality Systems Engineers, Quality Managers, Quality Directors, and VP of QA