Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects

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.

Why Should You Attend:

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.

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

Instructor Profile:

John R. Godshalk, B.S., MBA, is a Senior Consultant with the Biologics Consulting Group, Inc.

During his tenure at DMPQ, John gained experience with products that include drugs, drug/device combination products, viral and bacterial vaccines, recombinant therapeutic and fractionation products, in vitro diagnostic test kits, and 510K medical devices. His inspection experience includes leading inspections of active pharmaceutical ingredient manufacturers, aseptic filling and finishing facilities, and contract manufacturers. He has performed numerous pre-approval and pre-licensing inspections for biological and biotechnology products. In addition, he has evaluated industry responses both for technical and regulatory merit during FDA regulatory compliance actions, and has assessed these responses and offered alternative solutions to resolve technical issues and regulatory concerns.

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/pharmaceutical-and-biologics-facility-design-fds-and-regulatory-aspects-webinar-training-704841-prdw?channel=sciencedz