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TRAINING PROGRAM
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.
•cGMP, cGLP.
•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.
FACILITY
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.
LOCATION
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) 560-1366
(732) 560-9321 Fax
E-mail: tomerchromak@att.net
COURSE OUTLINE
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.
1.Introduction
Historical Perspective
Comparison of gas and liquid chromatography
Modern GC equipment – Packed and Capillary columns
Modern HPLC equipment
Chromatography parameters
Modes of liquid chromatography
Normal phase
Reverse phase
2.Practical and Theoretical Principles
Chromatographic process
Resolution
Capacity factor
Selectivity
Efficiency
Void volume
3.Chromatographic Analysis
Mobile phase
Flow rate
Column, pre-column and guard column
Column care
Priming and purging the pump
Sample preparation
Standard preparation
System suitability
Calculation
4.Gradient Elution
Purpose of gradient elution
Gradient profiles
Applications
Practical considerations
5.Liquid Chromatography Instrumentation
Pump
Injector
Column
Detector
Integrator/Data System
6.Gas Chromatography Instrumentation
Injector
Column
Detector
Integrator/Data System
7.Columns
Column hardware
Pre-columns and guard columns
Stationary phase
Support
Particle size
Pore size
8.Normal Phase Chromatography
Introduction
Retention mechanism
Solvent strength
Problems with silica and alumina
Applications
9.Reverse Phase Chromatography
Basic principles
Bonded phase preparation
Surface structure
Retention mechanism
Column selection
Solvents
Paired ion chromatography
Applications
10.Ion Exchange Chromatography
Separation principles in ion exchange
Ion exchange columns
Mobile phase
11.Size Exclusion
Separation principles
Gel Permeation vs. Gel Filtration
Column selection
Solvents
Calibration
Applications
12.Packed column GC
Support
Stationary phase
Applications
13.Capillary Column GC
Stationary phase
Internal diameter
Applications
INSTRUMENT – OPERATION
Attendees will operate HPLC, GC systems throughout the entire workshop and perform analysis of the following samples:
-Pharmaceuticals
-Food supplements
-Specialty chemicals
-Natural products
In addition to HPLC, four days training, workshop includes longer programs of.
Six week and three month with advanced topics, project work and extensive
Practice
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
Introduction
General procedure
Carrier gas
Capillary column
Packed column
Detectors
Sample analysis
Calculation
Documentation
2.THIN LAYER CHROMATOGRAPHY – TLC
Introduction
General procedure
Solvent system
Stationary phase
Plate development
Plate visualization
Documentation
3.DISSOLUTION
Summary
Principle
Dissolution medium
Apparatus
Instrument set up
Calibration
Sample analysis
Acceptance criteria
4.CURRENT GOOD MANUFACTURING PRACTICES – cGMP
Purpose
Requirements
Document Trail
Analyst Training
Written and validated test procedures
Calibration and maintenance of equipment
Record keeping
Check and review of raw data, calculations
Retest and re-sample
ADDITIONAL INFORMATION
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.
WORKSHOP HOURS
8:30AM to 5:30PM Saturdays, 8:00AM to 4:30PM Weekdays.
REGISTRATION/ TUITION
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
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