CHROMAK RESEARCH, INC.
Pharmaceutical Research, Analytical Research,
Routine Testing, Training and Consulting Services
350 CAMPUS DRIVE, SOMERSET, NEW JERSEY 08873
PHONE: (732) 560-1366FAX: (732) 560-9321
TRAINING & COURSE DETAILS
•Hands on training in HPLC, GC, TLC, UV, IR and Dissolution.
•FDA slide/ Tape Presentation on dissolution.
•Audio video presentation on HPLC, GC, weighing, pipeting and pH.
•Advanced training in methods development, methods validation and report writing.
•Tips on how to minimize retest and resample.
•How to write Investigation Reports.
•Notebook and Record keeping to meet FDA and Patent requirements.
•Video audio presentation on FDA inspection.
Training design is similar to the “Analyst Training and Certification Program” used by the FDA in their division of Drug Analysis to train FDA chemists.
Laboratories are fully equipped with standard laboratory equipment and state of the art analytical instrumentation including HPLC, GC, TLC, UV, IR, Dissolution apparatus, Electrophoresis units, muffle furnace vacuum ovens, stability chambers and HPLC column packing equipment.
Chromak Research laboratories are located in a park like setting in its own 17,000 sf building at 350 Campus Drive, Somerset, corporate business section, near Route 287 in central New Jersey, one hour drive from New York and Philadelphia.
REGISTRATION AND APPROVALS
•Registered with U.S. FDA, Registration No. 2248066
•Approved by New Jersey Department of Education “Laboratory-Hands on Training Program”, Dr. Tomer as Director and instructor.
•New Jersey Department of Consumer Affairs, No. TPO 104400
•U.S. DEA and EPA.
•New Jersey Department of Health.
For further details, please contact Dr. Tomer at:
(732) 560-9321 Fax
A. Theory, Practical and Instrumentation
This course concentrates on theory of separation in HPLC, GC, and operation of HPLC, GC, TLC, UV, IR and dissolution equipment. Hands on training include analysis of tablets, capsules, injections, bulk drug substances, validation of analytical methods, calibration of laboratory instruments and troubleshooting. Additional topics include current Good Manufacturing Practices (cGMP) and FDA audits.
Comparison of gas and liquid chromatography
Modern GC equipment – Packed and Capillary columns
Modern HPLC equipment
Modes of liquid chromatography
2.Practical and Theoretical Principles
Column, pre-column and guard column
Priming and purging the pump
Purpose of gradient elution
5.Liquid Chromatography Instrumentation
6.Gas Chromatography Instrumentation
Pre-columns and guard columns
8.Normal Phase Chromatography
Problems with silica and alumina
9.Reverse Phase Chromatography
Bonded phase preparation
Paired ion chromatography
10.Ion Exchange Chromatography
Separation principles in ion exchange
Ion exchange columns
Gel Permeation vs. Gel Filtration
12.Packed column GC
13.Capillary Column GC
INSTRUMENT – OPERATION
Attendees will operate HPLC, GC systems throughout the entire workshop and perform analysis of the following samples:
In addition to HPLC, four days training, workshop includes longer programs of.
Six week and three month with advanced topics, project work and extensive
AUDIO – VIDEO PRESENTATIONS
-DISSOLUTION; Slide – Tape from FDA
-HPLC, GC; Video – Audio Presentation
-FDA Inspection; Video – Audio Presentation
-Weighing, Pipeting and pH; Video – Audio Presentation
HANDS ON TRAINING IN THE FOLLOWING INSTRUMENTS
1.GAS CHROMATOGRAPHY – GC
2.THIN LAYER CHROMATOGRAPHY – TLC
Instrument set up
4.CURRENT GOOD MANUFACTURING PRACTICES – cGMP
Written and validated test procedures
Calibration and maintenance of equipment
Check and review of raw data, calculations
Retest and re-sample
Each workshop will be limited to only six participants. They are open to all qualified applicants subject to availability of space on a first-come, first-serve basis. Interested candidates are advised to register as soon as possible. Fees include Tuition, Course materials and Instructor’s notes.
8:30AM to 5:30PM Saturdays, 8:00AM to 4:30PM Weekdays.
A tuition fee of $500 for each two days of workshop will be charged to all attendees. All are requested to return the enclosed registration form along with the current resume and check or money order payable to Chromak Research, Inc.
Chromak Research, Inc.
350 Campus Drive
Somerset, NJ 08873
Following the registration, attendees will receive course material for study at home. Course material includes twenty most commonly asked questions and their answers. Student should be able to understand the questions and their answers prior to attending the HANDS ON TRAINING.
For more information:
Call (732) 560 – 1366 Fax (732) 560 – 9321