Help support the ASQ Princeton Section

Do you want to support your local quality orgainzation by sponsoring a dinner meeting? Contact us today to find out how you can get involved and become part of the the local Quality Community.

ASQ Unemployed or Underemployed Members

Any ASQ member who is unemployed or underemployed is eligible to receive a 50% discount on any course offered in the Fall of 2010 and the Spring of 2011. Check out the Education Page page for more details.

ASQ is also offering membership at a discount of 50% for unemployed members looking to renew. Please CLICK HERE to visit the ASQ National page for more details.

Pricing

Early Bird Pricing $250 ends 12/15/2011

Regular Pricing $300 ends on 1/18/2012

Walk-in Pricing $330 day of event.  We will accept credit cards, cash, and/or checks the day of the event.

Agenda

NOTE: The final agenda will be posted after final confirmation of all speakers

AGENDA DRAFT

TIME   

TOPIC

SPEAKER

7:00 – 8:00

Registration; Continental Breakfast and
Vendor Displays

Food and Vendor Booths

8:00 – 8:02

Welcome and Announcements

  Robert D. Seltzer,
Chair & Moderator, ASQ NE Pharma GMP Conf; 
Reg Compl Mg’r, GSKCH

8:02 – 8:15

ASQ FD&C Division & Princeton Section Programs and Educational Offerings

Alice Krumenaker &
Richard Herczeg

8:15 – 9:20

Swabbing Protocols for Cleaning Validation

Lara Soltis,
Mid-Atlantic Sales Manager, Texwipe an ITW Company

9:20 – 10:25

Toxicological Risk Assessment in Pharmaceutical Cross-Contamination and Impurities Issues

Robert G. Sussman, Ph.D., DABT, Managing Principal–
Eastern Operations

SafeBridge Consultants, Inc.

10:25 – 10:40

Morning Break

Food and Vendor Booths

10:40 – 11:45

 Drug contamination with halogenated anisole compounds, such as 2,4,6-tribromoanisole (TBA)

Robert A. Johnson,
President, PDA Metro Chapter

11:45 — 1:00

Standing Lunch & Networking

Food and Vendor Booths

1:05– 2:00

A Dose of Safety–
Keeping Contaminants Out of Your Product;
Tablet Metal Detection and X-Ray Technology

Ray Spurgeon, Jr.,
Product Manager of X-Ray Systems, Eriez Manufacturing Company

2:00 – 3:05

Managing Microbiological Risks from Product Development to Commercial Manufacture

Linda Skowronsky,
Sr Development Microbiologist, GlaxoSmithKline Consumer Healthcare R&D

3:05 – 3:20

Afternoon Break

Food and Vendor Booths

3:20 – 4:25

Corporate Challenges to the Quality Unit

Thomas Arista,
Office of Regulatory Affairs (ORA) Field Investigator National Expert Cadre, FDA

4:25 – 4:40

Concluding Remarks, Certificates of Attendance, and Door Prizes

Speaker Bio

Speaker Bio’s will be updated shortly.

Conference History

The Northeast Pharmaceutical GMP Conference (NEC), held annually in Central New Jersey, was first chaired by Anthony Carfagno (Tony)  approximately nineteen (19) years ago.  For 15 of those years, Tony guided this conference and invited numerous FDA officials, including famous field investigators among the usually 6 speakers per conference.

Tony passed the reigns of chairmanship of this conference to Robert Seltzer (Bob), a fellow member of ASQ’s Food Drug & Cosmetic Division (FD&C) and champion/founder of the ASQ Certified Pharmaceutical GMP Professional Exam.  The NEC, upon Bob’s entry as chair, began a joint sponsorship between the FD&C Division and the Princeton Section, ASQ (Note, in 2009, PDA Metro was a third co-sponsor—one year only).  This partnering of the FD&C Division ASQ with the Princeton Section ASQ has brought national and local strength to a great pharmaceutical GMP conference.

Our conference knows only the sky as its limit, and endeavors to invite current or past high-ranking officials Pharma and allied industries, from FDA, and from other competent authorities.  We have resisted the idea of multiple track conference in favor of a single pharmaceutical GMP track with a unique theme each year, this starting in 2009.   The conference is economically priced at $300 through the 19-Jan-2012 event at the Somerset, NJ Holiday Inn.

The NEC Planning Committee has prided itself on providing perhaps the best value conference anywhere in the world, especially when factoring in the location cost of catering/rental in Central NJ.   New Jersey is, historically, the world capital of the pharmaceutical industry, and deserves such a world-class annual conference.