The quality control (QC) laboratory is the nerve center of the pharmaceutical company — if analyses are incorrect, product may be erroneously released for sale and people can die.Faced with this stark reality, FDA and other worldwide regulatory agencies expend a great deal of time and effort inspecting QC labs and operations to assure that analyses are performed well and that the data generated is trustworthy. Since 1997, citations involving the QC lab have formed the largest single group of GMP deficiency citations generated by FDA, and are the cause of more companies failing FDA inspections than any other.This course is designed to assure that the testing performed in your laboratories is beyond reproach (by regulatory inspection agencies such as FDA and your clients), and that the results generated are trustworthy, believable, robust and GMP compliant. The process of acquiring sound, scientifically based data requires analytical methods that have been properly validated; tests being performed by qualified, trained personnel; and equipment that has been properly qualified. As science and technology become more exact, quantifiable and precise, the ability to perform competent analysis daily becomes more of a challenge. This course is designed to ensure that healthcare manufacturer’s laboratories operate in an efficient, GMP compliant manner. This course does not delve into the science behind laboratory testing, but into assuring that the laboratory meets its regulatory compliance requirements and the product of testing is reliable
Laboratory Management
Laboratory Analyst Training
Method Development
Method validation
Method Transfer
Reference Standards
Instrument Calibration and Qualification
This course is designed for all staff involved with pharmaceutical quality control laboratories — chemical, physical and microbiological. This course will be of particular interest and applicability to QC lab managers, QA managers and QA auditors, analytical development lab managers and anyone involved with the healthcare manufacturing and research industries
The presentation is generally appealing to me. The dedication & devotion of the instructor are both laudable & admirable.Mohammed F. AlotaibiSabic
Really this course is important for any inspector, so I will recommended it for our employees. And thanks a lot!Ahmed Al-YamiSabic
You are doing excellent bringing such very talented instructor. Please keep it up.Ahmed AfifiAl-Zamil CoolCare
I would like to appreciate you as well as the instructor for a good training due to the fact that the helping to gain new information about the types of valve with advantages and disadvantage as well. Many thinking.Zaki Ali AldawoodSabic
This course was very beneficial and helpful to understand one of the Major NDT method. I encourage ITC to continue with this performance.Talal Saad AlHasawiSabic
ITC service was in overall excellent. Thanks.Wael M. MorsyMobily
This course was good and a nice guide to the PMP exam. Thanks.Yazeed Mohamed MrekiGeneral Authority of Civil Aviation (GACA)
It was good course & good preparation with excellent instructor. Thanks a lot.Faisal Mahdi Al-QahtaniSabic
It was a nice course to have. I suggest taking this course with the same instructor to other people. Thanks for the instructor for his kindness & helfull during the course.Abdul-Moniem Al-HumoudSabic
It is very important course, which enable us to improve our knowledge to work approaching our big account and can be recall us the key account. This is will support us to active result for the best of the Co.Mohammed AmjadAl-Suwadi Services
The instructor is highly and technical knowledgeable in explaining all the subject in the course taken. Noel V. GaranColdstorec Group Of Saudi Arabia
Instructor was well prepared and knowledgeable I gain lot of useful information.Gulam KhanSaudi Aramco
It was a good learning experience. Got to know the concept involved in key account.Muthuraman NachiappanAl-Suwadi Services
The instructor Mr. Ahmed Sabry has a very nice spirit.Salam FakhouryAl Khodari Company
It is very useful to us and increase our knowledge.Mohammed Rashed AfifiAl Khodari Company
The course is excellent and helpful. It help me in organizing the work in more safe manner.Muzammil HayatAl Khodari Company
The instructor is very knowledge and hard working, his way of teaching is very good.Ibrahim DarwishAl Khodari Company