CATEGORY TYPE: Quality & Auditing

COURSE NAME:Quality Control in Testing laboratories


This course can be scheduled at your convenience, to request this course please click here


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

  • understand why an efficient laboratory is typically a compliant laboratory
  • know the key hot button issues FDA notes in QC laboratories
  • learn the top ten issues FDA finds fault with laboratories during their inspections
  • understand what it takes not to have negative FDA observations about your laboratory
  • recognize the concept of being in control and what it takes to perform FDA acceptable investigations


Laboratory Management

  • Managing for laboratory efficiency
  • Standard analytical times
  • Staffing requirements
  • Laboratory space requirements
  • Electronic records (21CFR11) — current status of FDA regulations and their impact on the lab
  • Spreadsheet validation — what is required and how to do it
  • Laboratory deviations, incidents and being in control
  • Performing effective, acceptable out-of-specification (OOS) investigations and getting to root causes


Laboratory Analyst Training

  •   The 13 core laboratory SOPs all analysts must know before beginning work
  • Laboratory mathematics, manipulations and records
  • Systematic errors
  • Pharmacopoeias
  • USP — mandatory elements, voluntary elements
  • ICH guidelines
  • FDA and their role in laboratory testing
  • GMP/GLP requirements of laboratories and analysts
  • Handling out-of-specification situations
  • Handling out-of-trend situations
  • FDA warning letters — tools for training


Method Development

  •   Method development planning
  • Assay simplicity and robustness
  • Assay economics
  • Analytical method life-cycle


Method validation

  •  FDA expectations for analytical method validation
  • Accuracy, precision, linearity
  • Range, specificity, robustness
  • ICH guideline requirements


Method Transfer

  •   Method transfer from analytical development to method user
  • Objective assessments of successful method transfer
  • Lab-lab method transfer; analyst-analyst method transfer


Reference Standards

  •  Primary standards
  • Characterization of standards
  • Working (secondary) standards
  • Compendia standards
  • Reagents and buffers — formulations and expiration dating


Instrument Calibration and Qualification

  •   Instrument calibration fundamentals
  • Calibration of pH meters, balances, incubators, refrigerators,
  • IQ/OQ of laboratory water systems, stability chambers, GCs/HPLCs, spectrophotometers
  • Instrument qualification explained




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

    • 5 Day(s)

    The presentation is generally appealing to me. The dedication & devotion of the instructor are both laudable & admirable.
    Mohammed F. Alotaibi

    Really this course is important for any inspector, so I will recommended it for our employees. And thanks a lot!
    Ahmed Al-Yami

    You are doing excellent bringing such very talented instructor. Please keep it up.
    Ahmed Afifi
    Al-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 Aldawood

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    Talal Saad AlHasawi

    ITC service was in overall excellent. Thanks.
    Wael M. Morsy

    This course was good and a nice guide to the PMP exam. Thanks.
    Yazeed Mohamed Mreki
    General Authority of Civil Aviation (GACA)

    It was good course & good preparation with excellent instructor. Thanks a lot.
    Faisal Mahdi Al-Qahtani

    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-Humoud

    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 Amjad
    Al-Suwadi Services

    The instructor is highly and technical knowledgeable in explaining all the subject in the course taken.
    Noel V. Garan
    Coldstorec Group Of Saudi Arabia

    Instructor was well prepared and knowledgeable I gain lot of useful information.
    Gulam Khan
    Saudi Aramco

    It was a good learning experience. Got to know the concept involved in key account.
    Muthuraman Nachiappan
    Al-Suwadi Services

    The instructor Mr. Ahmed Sabry has a very nice spirit.
    Salam Fakhoury
    Al Khodari Company

    It is very useful to us and increase our knowledge.
    Mohammed Rashed Afifi
    Al Khodari Company

    The course is excellent and helpful. It help me in organizing the work in more safe manner.
    Muzammil Hayat
    Al Khodari Company

    The instructor is very knowledge and hard working, his way of teaching is very good.
    Ibrahim Darwish
    Al Khodari Company