Course Number: 203

Facilities and Equipment – Linking the Latest FDA , EMA and Other Regulatory Bodies' Regulatory Expectations With Respect to Design, Construction, Start Up and Commissioning of Facilities and Utilities to Best Practices

Live, Interactive Training Webinar

Date: Thursday April 11, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Peter Calcott Ph.D. Biography>>>

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In the FDA, EMA and most 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.

In this Live Webinar, we will walk 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.

Learning Benefits:
-The expectations of the FDA and EMA and other regulatory bodies with respect to design, construction, start up and commissioning of facilities and utilities.
-How to maximize the output of your validation and qualification activities for your facilities, utilities and equipment yet minimize the input or work involved.
--How to tie the qualification processes to routine operations in an efficient and compliant manner including calibration and maintenance and periodic assessments of the qualified state of systems.
-Where companies fail to deliver a compliant systems putting their operations and compliance state at risk.

Webinar outline and time breakdown:

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM What exactly are the agencies requiring: what do the regulations mean?,
Linking design, construction and procurement to operations,
The linkage of Quality, cost and time – which two do you want?
Mechanically complete – an oxymoron,
Common pitfalls at the juncture of qualification,
11:30 AM Break
11:40 AM A critical look at facility qualification,
Challenges with utility qualification,
One size fits all for equipment qualification,
Conclusions,
12:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance Personnel
  • Quality Control Personnel
  • Supply Chain and Logistics Managers
  • Regulatory Affairs Professionals
  • Process Development Scientists and Management
  • Manufacturing Management and Scientists
  • Project Managers working in the CMC arena
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Instructor: Peter Calcott Ph.D.

Peter H. Calcott, Ph.D. is President, Calcott Consulting which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance and enterprise e-solutions. He is also an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs. Prior to this he was VP at the executive team level at PDL BioPharma where he was responsible for development and implementation of Quality & Compliance strategy across the corporation… Full Bio>>>

 

 

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland