Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Practical Approach Webinar training seminars presented by Online Compliance Panel register now on FindaSeminar.com
findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Practical Approach Webinar  
 Email information about this seminar Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Practical Approach Webinar by Online Compliance Panel to yourself your manager or associates Email this event... View and register for other training seminars like Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Practical Approach Webinar by Online Compliance Panel on FindaSeminar.com Find similar training.. Find and register for other training seminars by Online Compliance Panel on FindaSeminar.com Other seminars from Online Compliance Panel

By:

Online Compliance Panel   

For:

Cost:   
see Registration info for seminar cost, group discount etc.

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)
 

 Seminar / Training class dates & locations

 
 SORT RESULTS BY:

 DATE

LOCATION

SELECTED VENUE DETAILS

Facility Name: 
Address:





Registration Information:

Event cost:  $USD

class times and cancellation policy

 
 




 From 
 To 
 Click to register by Register by fax for Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Practical Approach Webinar training seminar Register by mail for Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Practical Approach Webinar training seminar Register by phone to attend Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Practical Approach Webinar training seminar

Print payment approval request form Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Practical Approach Webinar training seminar

Pre-Registration questions? Find answers in our registration FAQ or Request information about upcoming training seminars workshops and conferences in   and other cities listed on FindaSeminar.com Submit a support request

 
 

 

share this page 

print the agenda print agenda for the Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Practical Approach Webinar seminar

 

 

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)

print this agenda print agenda for the Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Practical Approach Webinar training seminar

 view dates and locations for this seminar

 

  

 

Custom Search