Rocky Mountain Regulatory Affairs Society (RMRAS)


ROCKY MOUNTAIN RAS JUNE 25 MEETING

3:30 pm – 4:00 pm                    Registration and Networking

 4:00 pm – 5:00 pm                    Chemistry Manufacturing Controls

 Front Range Community College 

Library – Room L-211

Westminster, Colorado

Please RSVP to rmras@themattgrp.com

 Rocky Mountain RAS is very pleased to present Robert Kasubick as our June 2008 speaker focusing on the topic of the Chemistry Manufacturing Controls section, practical advice for submissions and pitfalls to avoid.

 Based on our 2008 membership survey, this topic was the first choice under the Pharmaceutical topics, so we hope it is of interest to our members.

 Speaker Bio

Robert Kasubick’s career of over 20 years includes extensive experience as an executive in top-performing pharmaceutical, health and beauty products and leading operations from start-ups to mature organizations. With an entrepreneurial-ownership attitude, he is skilled at contract manufacturing, reorganizations, turnarounds, process improvements, FDA negotiations, international expansions, and new facilities designs.  Most recently Robert Kasubick was Chief Operating Officer of ABS Corporation that serves independent and Fortune 500 Companies.  With a manufacturing budget of $17 million, management of three manufacturing plants and a staff of 42 within five departments, he was the key executive for increasing international presence for the start-up pharmaceutical, nutraceutical company (servicing cosmetics, supplements, proteins, vitamins and veterinary products for the companion animals industries). He utilized full strengths of operation, manufacturing, and compliance as well as launched APHIS and organic certification projects, statistical process improvements, and four new product launches.

Directions from Denver

Take I-25 to Hwy 36 toward Boulder

Take Hwy 36 to Sheridan Blvd, exit north

Stay on Sheridan to 112th Avenue, turn east

Go ½ mile and Front Range Community College will be on your left

Turn left into the first street into the parking lot and enter the building at the main entrance.

Take a left, go through the Library and Room L-211 is on your left.

[For further directions, call 303-404-5539]

Directions from Boulder

South on Highway 36 to 104th Avenue (Church Ranch Blvd) exit

East on 104th Avenue one mile to Sheridan Blvd

North on Sheridan Blvd to 112th Avenue

East on 112th Avenue, go .5 mile – Front Range will be on your left.

Turn left into the first street into the parking lot and enter the building at the main entrance.

Take a left, go through the Library and Room L-211 is on your left.

[For further directions, call 303-404-5539]