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ISPE NJC January 21 2009 GMP HVAC Training Class

East Syracuse, NEW YORK 13057
ISPE NJC January 21 2009 GMP HVAC Training Class

Ticket Information

Ticket Type Price Fee Quantity
Member $500.00 $0.00
Non Member $750.00 $0.00

Event Details

ISPE NJ EDUCATION COMMITTEE PRESENTS:

 

The first in a series of one-day classes on critical issues for engineers in the Pharmaceutical / Biotech and Medical  Device industry:

 

GMP HVAC Design for Bio/Pharmaceutical and Medical Device Facilities

 

Good operational practices may be the key to good cGMP operations,  but a poor facility design can hamstring even the best operations.  Learn the real cGMPs of HVAC for facilities across the global market place. Explore common misconceptions with a special focus on misunderstood and often overlooked issues. Identify the hallmarks of good HVAC design and the tell-tale signs of underlying problems. 

 

The program focuses in three core areas:

·         Cleanroom Theory – Discuss critical factors in cleanroom design, such as filter mechanics, dilution vs. displacement, airflow vs airchange and how they relate to product protection.

 

·         Regulations – Review HVAC related regulations from around the world, with special focus on FDA and EMEA cGMPs.

 

·         Design Process, Considerations and Typical Designs – Review the design process and tradeoffs HVAC designers must make, along with common solutions organized by facility type.

 

“ISPE will provide continuing education units (ISPE CEUs) for training courses. This course will provide .60 CEUs. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of receipt of evaluation materials."

 

DATE:                    Thursday January 21 – 8:30am – 5:00pm

LOCATION:         PS&S – Building “A”, 67A Mountain Boulevard Extension, Warren, NJ 07059

INSTRUCTOR:    Norman Goldschmidt, Principle and VP Genesis Engineers

Member Price                   $500.00

Non-Member Price          $750.00

 

 

 

COURSE DESCRIPTION:

This course is an excerpt from the popular three-day ISPE “HVAC for Pharmaceutical Facilities” class. In our one day program we will cover:

 

Cleanroom Theory – Discuss critical factors in cleanroom design and how they relate to product protection

·         filter mechanics

·         dilution vs. displacement

·         airflow vs airchange

·         Effective Ventilation Rate

·         Particle Generation sources and rates

 

Regulations – Review HVAC related regulations from around the world

·         FDA

·         EMEA

·         WHO

·         PIC/S

·         TGC

 

Design Process, Considerations and Typical Designs – Review the design process and tradeoffs HVAC designers must make, along with common solutions organized by facility type.

 

·         Risk Assessment

o   Discuss how this approach cuts through the masses of machinery and documentation to focus efforts for greatest benefit to patient and public.

 

·         Cross-contamination control

o   Learn common Potent Compound handling evaluation techniques and equipment and how they relate to cross-product contamination.

 

·         Energy Savings vs contamination control

o   discuss methods for conserving energy and the associated risks/rewards.

 

 

Learning Objectives:

This is an intermediate / advanced class, it is assumed that all participants will have a solid background in HVAC principles and terminology, basics will not be covered.  The HVAC course explores these concepts more fully.

1.       Regulations

a.       Review the language in regulation as it applies to HVAC

b.      Compare cGMPs from different jurisdictions

c.       Discuss the conflicts between cGMP and other regulations

2.       Cleanroom Theory

a.       Gain an understanding of basic cleanroom theory including:

b.      Types of cleanrooms and flows

c.       Effect of people on room cleanliness

d.      The relationship between filter rating vs mass and particle count efficiency

3.       Design Process and Considerations

a.       Understand the HVAC design process in our industry

b.      Understand some critical issues that HVAC designers face Bio- pharmaceutical company

c.       Understand the relationship between product potency vs. cross-contamination and resultant facility design features.

d.      Review typical designs for HVAC by facility type

e.      Discuss common energy saving practices, their pros and cons

 

Instructor:

Norman Goldschmidt is a Principle and VP of Engineering at Genesis Engineers, Inc. a full-service Engineering, Design/Build and CQV firm based in Plymouth Meeting PA.  Prior to joining Genesis Mr. Goldschmidt founded Pharma Engineering Advisors, a consultancy specializing in sustainability, facility compliance and capital portfolio management practices within the life sciences industry.

 

Norman has over two decades of experience in the life sciences, having served as Senior Director in Global Engineering at Bristol-Myers Squibb (BMS) for 20 years. At BMS his organization was responsible to conceive, plan and design every facet of facilities necessary to deliver drug products to market, from Discovery and Development through Manufacture, Packaging and Delivery of all types of Drug Product.

 

Mr. Goldschmidt studied mechanical engineering at the University of Buffalo and business at Empire State College. He holds four patents for innovations in HVAC and Pharmaceutical Processing, is a member and author on several ISPE, ASHRAE and ISO technical committees, was team lead for the recent ISPE HVAC GPG and is a frequent guest lecturer for ISPE, ASHRAE and others.

 

GMP HVAC Design for Bio/Pharmaceutical and Medical Device Facilities

Thursday January 21 – 8:30am – 5:00pm

PS&S – Building “A”

 

 DIRECTIONS TO

PAULUS, SOKOLOWSKI AND SARTOR, LLC

67A Mountain Boulevard Extension
Warren, NJ 07059
(732) 560-9700

 

 

From Western NJ:     Rt. 78 east to Exit 36 and turn right at exit.  Proceed to Mountain Boulevard (approx. 3 miles).  Make right at light.  Go ¼ mile down on the right, see sign which reads  “Paulus, Sokolowski and Sartor.”  Make first right into parking lot.  Make next right to Building 67A.  See first floor Receptionist.

 

From Eastern NJ:      Rt. 78 west to Exit 36 (Basking Ridge/Warrenville).  Turn left and proceed 3 miles to Mountain Boulevard.  Make right at light.  Go ¼ mile down on the right, see sign which reads  “Paulus, Sokolowski and Sartor.”  Make first right into parking lot.  Make next right to Building 67A.  See first floor Receptionist.

 

From Rt. 22 West:   Going east on Rt. 22 from Somerville to Warrenville Road.  Take jug handle turn across Rt. 22.  Go right up Warrenville Road (hill) approx. 2.5 miles to 1st traffic light.  Make left onto Mountain Boulevard Extension.  Go ¼ mile down on the right, see sign which reads “Paulus, Sokolowski and Sartor.” Make first right into parking lot .  Make next right to Building 67A.  See first floor Receptionist.

 

From Rt. 22 East:     Going west on Rt. 22 to Warrenville Road.  Go right up Warrenville Road (hill) approx. 2.5 miles to 1st traffic light.  Make left onto Mountain Boulevard Extension.  Go ¼ mile down on the right, see sign which reads “Paulus, Sokolowski and Sartor.” Make first right into parking lot.  Make next right to Building 67A.  See first floor Receptionist.

 

From South Jersey:    Take Route 287 North to Exit 14 and take Route 22 East.  Exit at Route 527 North for Mountain Boulevard North.  At T junction take right turn on Washington Valley Road.  Look for Paulus, Sokolowski and Sartor sign on left side about ½ mile down the road.  Take left turn into the parking lot and go to Building 67A on right side.  Go to Receptionist on first floor for the Mechanical Department.