Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Practical Approach

Duration: 90 Minutes
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.
Complying with FDA regulations
Instructor: Cezar Lucki
Product ID: 509127
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
Who will Benefit
  • Validation Engineers
  • Quality Engineers
  • Quality Systems Engineers
  • Quality Managers
  • Quality Directors
  • VP of QA
  • Engineering
  • Project Management
  • Commissioning and Qualification
  • Quality Assurance
  • Regulatory Affairs
  • Manufacturing and Operations
  • Building contractors
$375
Recorded Session for one participant
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Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Cezar Lucki has over 22 years' experience working in the FDA/EMEA regulated industry in the area of Medical Devices (Class 1-3), IVD's, Pharmaceuticals (including API and solid-dose), Biotech (Biologics & Vaccines), Cosmeceuticals and Neutraceuticals with over 15 years in CSV's (computerized systems validations & software validations), Equipment, Process, Facility/Utility, Cleaning, and Test Method Validations. As a Project Manager and QE he has brought facilities, manufacturing, laboratory systems, engineering controls, and enterprise systems into compliance for start-up, expanding, in acquisition and companies under consent decree, 483's, and warning letter remediations. He has presented various seminars on the topic of validations and compliance in Philadelphia, Boston, Princeton, San Diego, and Europe.

He has a full understanding and experience working with 21CFR Part 111, 21CFR Part 211 (cGMP), 21CFR Part 58 (GLP), 21CFR Part 820 (QSR), 21CFR Part 11 & Annex 11 (ERES), ANSI/ASQC Z1.4/Z1.9, ICHQ guidelines, EMEA GMP - 91/412/EEC & 91/356/EE, ISO 9001/2/3, ISO13485, ISO 14644, EN45001 / ISO17025, IEC 62304 / IEC 12207 / IEC 15288, 60601-1, ISO 14971, EN 61010, IEC 60812 (FMEA), and ASTM E2500.
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