Chapter Day 2009 June 17, 2009



The NJ Chapter of ISPE is proud to present a day of symposia on various topics including several talks regarding standards followed by the pharmaceutical industry. This year we have moved the location of this event to allow us to present five different technically related sets of informative seminars. The five areas to be covered include- New Happenings in Automation, Electronic Communication including Wireless and Batch Reporting, Design of Pharmaceutical Equipment, New Happenings in Validation and Regulatory, and Safety and Environmental Practices in the Pharmaceutical Industry. Two sessions are given by representatives of our partner for this event- The International Society of Automation.

ISPE NJC offers the most broadly based day of seminars we have ever offered. Dean Ford of Maverick Technologies describes a paperless plant operation in the pharmaceutical production industry. He will describe how real time data is sent from a manufacturing execution system to an ERP effort, the company CFO and other decision makers.

 Sam Herb, a veteran of the instrument and control industry has much experience at Moore Industries and Invensys.  He will enlighten us on how wireless technology is developing in this post 9/11 world. Encryption codes are getting safer and safer (harder to decode). The savings on wire and conduit that wireless operation leads to will be shown to be significant.

 We will have a thorough overview of recent developments in Biological Downstream processing by Steve Orichowskyj, of CDI Life Sciences. The challenges of purifying the higher titers and volumes of today’s bioreactors will be covered, as will the implementation of new technologies. Nick Andreopolous and Graham Wrigley will relate a case study regarding the implementation of the principles of ASTM A2500 at Pfizer,  an industry leader in implementing PAT among other cutting edge methods.

 Peter Blok of Pharma Team USA will cover Supply Chain Safety considerations, particularly as applied to drug shipment originating outside the US. RFID technology is used to track material movement, and certify products as authentic, in the age when an attack can come at any time from terrorist counterfeiters and tamperers.

 A different type of study will be offered by Cindy Lawton regarding the Ergonomics of Performing work in Isolators. Cindy is from Skan and will go over typical injuries that result from this type of work and how to address them.This years Chapter Day features some unique presentations which you won’t want to miss. Tom Moon, a veteran field construction safety professional from Torcon, will describe some of the issues OSHA brings up when they visit your construction site, and how to avoid serious financial and legal consequences through proper planning. Alex Habib of Maverick Technologies will describe how a small investment in process controls and automation can give big improvements in productivity. Return on Investment can be as short as one year for these expenditures,.illustrating how even cash strapped companies can improve their bottom line.

CANCELLED - Ramu Veerapan of Lifecycle Technologies, will speak on Understanding the changing landscape of EPC regulations and developing Track & Trace solutions . This topic is related to global supply chain integrity and anticounterfeiting, regulatory compliance, and packaging.  It is an area of growing concern for the FDA, industry and the nation’s supply of safe and efficacious drugs.  

Joe Smith of ABB will explain how to justify the use of usually high-priced real time process analyzers to document product quality. Technologies such as NIR and FTIR can conceivably eliminate many trips to the analytical laboratory and sometimes be integrated into a firm’s PAT strategy. Paul Melamud , an experienced field validation person, of Q Pharma will give a comprehensive history of our current GMP regulations, including up to the minute additions in 2009. 

Doug Petrone of Frazier Brothers will introduce us to the various types of warehouse material handling systems and storage media which are commercially available. He will cover when each is used and compare the relative merits and costs of each. Concepts of how to design a structure to optimize stage and retrieval will be touched upon also.

Our presenters are leaders in their fields. Among them are four personnel from Pharmaceutical Manufacturing firms, ten suppliers of equipment to the industry, and fourteen consultants including several architect- engineering firms. Specific areas to be discussed include PAT/Quality by Design, Can Wireless be Secure?, Downstream Processing, Conflicts between GMP and Green practices, and Plant Modernization Using Automation.
     New Member Orientation will be offered from 9:00am - 10:00am in the Imperial Ballroom and a Career Center will be available all day. Please email your resume or candidates qualifications to the originating author of this message.
     Please email your resume or candidates qualifications to
  • Selected vendors will be on hand to display and discuss their related products in a tabletop venue.
  • Registration at the Bridgewater Manor begins at 8:00am.  Pre-Registration is strongly recommended, as space is limited for sessions.
  • Lunch will be served buffet style from 12:30pm - 1:30pm, and refreshments will be available throughout the day 
  • Cocktails and hors d'oeuvres from 4:30pm – 6:00pm. (Cash bar)
  • Registration Forms must be received no later than June 16, 2009. The form is set up to enable you to choose 1st and 2nd choices for the sessions you prefer.
  • Fees are $125 for ISPE or ISA members and $150 for non-members (of ISPE or ISA).  (Non-members: if an ISPE membership application is included with payment the price will be discounted to the $125 member rate).
For additional information please contact Ron Dunn, NJ ISPE Chapter Manager at

Track 1



Equipment Design

Track 2

Imperial Ballroom

Validation Regulatory

Track 3

Hunterdon Room

Electronic Communication

Track 4

Somerset Room


Track 5

Warren Room

Safety/ Green Design Issues





9:00am - 10:00am

Session A1

Split Butterfly Valve Technology

Thomas Smith

GEA Pharma Systems

Session B1


Session C1

Wireless Communications

Bruce Manthe


Session D1

Packaging Automation

Murugan Govindasamy


Session E1

Intro to ISPE Sustainability

Paul Malinowski

Becton Dickinson





Session A2

Warehouse   Material Handling  

Doug Petrone

Frazier Industrial Co.


Session B2

History of GMP Regulations

Paul Melamud

Q Pharma 

Session C2

Enterprise Integration Systems

Dean Ford

Maverick Technologies 



 Session D2

Plant Modernization using Automation

Alex Habib

Maverick Technologies

Session E2

Ergonomic Efforts to Reduce Isolator Worker Injuries

 Cindy Lawton




Session A3


 Steve Chenal

Getinge USA

Session B3


Alex Brindle

 NNE Pharmaplan

Session C3



Josh Davies


Session D3

PLC/DCS/PC and Hybrids

Mike Andres-Gomez


Session E3

 Surrogate Testing Downflow Booths

John Kremer




                          Lunch Buffet & Tabletops (Imperial Ballroom)                    



Session A4

Developments in Downstream Processing

Steve Orichowskyj

CDI Life Sciences

Session B4

ASTM 2500 Case Study

Nick Andreopoulos

Graham Wrigley


Session C4

  Can Wireless be Secure?

Sam Herb


Session D4

RFID Pedigree & Authentication

Peter Blok

Pharma Team USA

Session E4

IAQ Based Control in Labroatories

Gordon Sharp




                                        Break & Tabletops (Imperial Ballroom)                       



Session A5

   BPE Update   

Dave Marks

DME Alliance

Session B5

Process Validation

   Chris Ames  

Catalent Pharma Solutions

Session C5

Batching Reporting

Bob Engel


Session D5

Justification   of Process Analyzers 

Joe Smith


Session E5

Chilled Beams

Barry Barnet



Session A6

GMP/Green Conflicts

Bruce Eckman

WBE Consulting

Session B6

Instrument Calibration/


Simon Lauffler



Session E6

Top 5 OSHA Red Flags

Tom Moon

Torcon, Inc.



                           Cocktail Hour & Tabletops (Imperial Ballroom)                    


Table Top Sponsorship Opportunities Available Please register above 

  • Please complete the Registration above to reserve your space.
    Registration must be received NO LATER THAN June 16th, 2009

    Cancellations received after 12:00 p.m. on June 16th, 2009 and "no shows" will still be billed.

  • Tickets
    Name Sales End Price
    Member Ended $125
    Non-Member Ended $150
    Late Entry Attendee (4:30pm to 6:00pm) No education sessions Ended $15
    Student - Member Ended Free
    Student - Non-member Ended $25
    Table Top Display Ended $400
    Super Tabletop (2 Connected Tables) Ended $650
    Event Sponsor (w/ TableTop-purchased separately) Ended $500
    Event Sponsor (w./ Tabletop Display) Ended $1000
    Lunch Sponsor Ended $500
    Cocktail Hour Sponsor Ended $250
    Beverage Break Sponsor Ended $100

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