CATEGORY TYPE: Quality & Auditing

COURSE NAME:Quality Control in Testing laboratories


UPCOMING EVENTS


START DATE END DATE CITY/COUNTRY PRICE Request
This course can be scheduled at your convenience, to request this course please click here
INTRODUCTION:

 

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

OBJECTIVES:
  • 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
OUTLINE:

 

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

 

WHO SHOULD ATTEND:

 

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

DURATION:
    • 5 Day(s)
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    The presentation is generally appealing to me. The dedication & devotion of the instructor are both laudable & admirable.
    Mohammed F. Alotaibi
    Sabic

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    Sabic

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    Al-Zamil CoolCare

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    Sabic

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    Sabic

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    Wael M. Morsy
    Mobily

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    Yazeed Mohamed Mreki
    General Authority of Civil Aviation (GACA)

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    Faisal Mahdi Al-Qahtani
    Sabic

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    Sabic

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    Al-Suwadi Services

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    Coldstorec Group Of Saudi Arabia

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    Saudi Aramco

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    Al-Suwadi Services

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    Al Khodari Company

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    Mohammed Rashed Afifi
    Al Khodari Company

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    Al Khodari Company

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    Ibrahim Darwish
    Al Khodari Company