Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
Instructor:
John R Godshalk
Product ID: 704841
Training Level: Intermediate
- Duration: 60 Min
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.
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.
Learning Objectives:
- 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
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
John R Godshalk
Senior Consultant, Biologics Consulting Group
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.
John has developed and given training programs for the FDA and regulated industry on pharmaceutical water, processing and instrumentation, lyophilization, cleaning methods and validation, and facilities for cell and gene therapy. He contributed to formulation of FDA policy as a member of the committee writing the Guidance Document for the Facilities and Controls for Cellular and Gene Therapy Product Manufacturing Operations.
John has served as chair in the review of the Chemistry Manufacturing and Controls (CMC) sections of Biologics License Applications and Supplements for both novel and licensed biological products at CBER. He has trained CBER staff on the scientific and regulatory review and evaluation of these applications and supplements.
Prior to joining FDA, John was a research engineer in industrial biotech. He also used his business experience and MBA as a consultant in the areas of business planning, marketing, information technology and strategic planning, financial modeling and analysis, budgeting, business process engineering, project management, and management consulting.
More Training By Experts
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