HVAC Cleanroom Design Concepts for Pharmaceutical cGMP - Course 10020

HVAC Cleanroom Design Concepts for Pharmaceutical cGMP

Attributes
  • Time: 1:00 p.m. - 5:00 p.m.
Coordinator Tamara Mandell     email: tmandell@cerhb.ufl.edu     phone: 386.462.6397
Description

HVAC Cleanroom Design Concepts for Pharmaceutical cGMP

Topics described and discussed in this lecture-based course include, but are not limited to, the following:

  • Interactive Classroom design of Oral Solid Dosage (Non-Potent)
  • Interactive Classroom design of Oral Solid Dosage (Potent)
  • Design differences between Single Product vs. Multi Product
  • Design differences between Potent and Non Potent
  • Temperature and Humidity requirements
  • ACH vs. Class vs. Application
  • HVAC Risk Assessment
  • Developing Proper User Requirement Specifications
  • FDA vs. EU Requirements
  • Class A, B, C, D and CNC Requirements and Applications
  • Class 100, Class 10,000 and Class 100,000 Requirements and Applications
  • ISO 5, 7 and 8 Requirements and Applications

We will have an interactive discussion about common design and maintenance issues which will allow attendees to address their specific challenges.

Registrants are encouraged to email any specific topics that they would like to see addressed to Tammy Mandell: tmandell@cerhb.ufl.edu.

                    

INSTRUCTOR BIOGRAPHY:

David Bess is the owner and principal of Advanced Systems Engineering, Inc. in Clearwater, Florida, and is in charge of all aspects of engineering and administration. David has extensive experience in providing mechanical engineering services for multiple industry sectors: LEED projects, State and Local Governments, Healthcare, Pharmaceuticals/Industrial, and Commercial. With over 24 years of experience in the industry, David is an expert in all aspects of Mechanical engineering and has a passion for working with complex mechanical systems. David is currently licensed in 15 states throughout the US and is a member of ASHRAE, ISPE, BioFlorida, and ASPE. 

HVAC Cleanroom Design Concepts for Pharmaceutical cGMP

Topics described and discussed in this lecture-based course include, but are not limited to, the following:

  • Interactive Classroom design of Oral Solid Dosage (Non-Potent)
  • Interactive Classroom design of Oral Solid Dosage (Potent)
  • Design differences between Single Product vs. Multi Product
  • Design differences between Potent and Non Potent
  • Temperature and Humidity requirements
  • ACH vs. Class vs. Application
  • HVAC Risk Assessment
  • Developing Proper User Requirement Specifications
  • FDA vs. EU Requirements
  • Class A, B, C, D and CNC Requirements and Applications
  • Class 100, Class 10,000 and Class 100,000 Requirements and Applications
  • ISO 5, 7 and 8 Requirements and Applications

We will have an interactive discussion about common design and maintenance issues which will allow attendees to address their specific challenges.

Registrants are encouraged to email any specific topics that they would like to see addressed to Tammy Mandell: tmandell@cerhb.ufl.edu.

Instructor: David S. Bess, P.E., Advanced Systems Engineering, Inc.