Managing the QC Laboratory in a GMP Compliant Manner
Assure that your laboratory stays out of trouble
with FDA
On this page...
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 |
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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 |
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.
Course Langauge
English
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.
Course Outline
| Laboratory Management |
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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 |
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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 |
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Method development planning
Assay simplicity and robustness
Assay economics
Analytical method life-cycle |
| Method validation |
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FDA expectations for analytical method validation
Accuracy, precision, linearity
Range, specificity, robustness
ICH guideline requirements |
| Method Transfer |
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Method transfer from analytical development to method
user
Objective assessments of successful method transfer
Lab-lab method transfer; analyst-analyst method transfer |
| Reference Standards |
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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 |
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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