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Individual e-Learning



Managing the QC Laboratory in a GMP Compliant Manner

Assure that your laboratory stays out of trouble with FDA

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Benefits of attending for you and your company

At the end of the course you will...

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

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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.

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Course Langauge


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Course Overview

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.

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Course 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
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
Compendial 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

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Previous Participant Testimonials

I enjoyed the course very much. It was very complete. Taking into account that one day is quite a short time to give a general overview of such an extended topic, I must say you reached the objective amply.
Anna Ripoles, Laboratorios Esteve

Excellent job on the training. I feel like I have a better handle on the topic.
Keith F. Kyle, Blue Mountain Quality Resources

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