Training Course Syllabus:

Objectives of the Presentation

• Knowledge of regulatory requirements / industry standards


• Strategizing techniques to leverage time, budget and priorities


• Avoiding common mistakes while bringing a facility into operation


• Emphasis on the basics: Mechanical, Electrical, and Architectural design


• Emphasis on additional components such as gasses, ESD, compressed air and backup generator


• FDA´s main / consistent focus with respect to 483´s

Why Should you Attend

In the FDA regulations, very little is said to guide you in what they expect of you with respect to design, construction, commissioning and start-up of facility, utility or equipment operations. Regulations are more focused on the output and operational aspects including the qualification and validation of activities. So many professional societies (PDA, ISPE) have taken the lead to aid practitioners to do the job right. But these are not regulations or even guidance; they are the industry´s interpretation of how to get to the finish line with minimal incidents.


Insight will be provided into companies having a short/limited time to incorporate Facility, Utility, and Equipment compliance with respect to 21 CFR Part 820, Part 211, and International Standards, where construction is dynamic and actual deliverables are not as planned. This is a common situation which puts strain on resources and budget, as a cause of scope creep and deviation from original design plans.


Comparisons will be made between theoretical project plan and common issues that arise during a facility expansion or construction of a new facility.

Areas Covered

• Project Team Planning


• Validation Planning


• Commissioning


• Qualification and Validation


• Plant Start-up


• Handling Scope Creep, Resources, and Budget


• Planned vs. "As-Is" Deliverables and Activities


• Avoiding unnecessary over-qualification


• Strategic Validation Planning for on-site Government Body Inspection

Seminar Summary:

In this Live Webinar, the speaker will walk you through the major areas of a plant, including the facilities, utilities and equipment in a critical manner to link best practices to the overall expectations of the agencies. That is the facilities, utilities and equipment design, construction, commissioning and start-up to the objective of assuring that they will lead to successful operations to yield consistent, reliable production free from cross contamination: the overall objectives of all regulatory bodies. We will focus on the qualification of these systems to assure this contributes to successful operations through the lifecycle of the plant and its operations. We will discuss strategies to operate efficiently, yet compliant in a risk based approach driven by data and scientifically driven means. (see full course description)

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