Laboratory (Analytical, Microbiology, Nonclinical)


Analytical Laboratory - GMP

Out of Specification & Atypical Results

Lesson Code: PGL-500. Discusses Out of Specification (OOS) and Atypical results. It includes their possible causes, the investigation process and preventive measures.

Laboratory GMP

Lesson Code: PGL-610. GMP in the laboratory, from sample receipt, testing and recording of results to result approval.

Analytical Laboratory - Validation

Method Validation Parameters

Lesson Code: PVL-310. Method Validation in terms of analytical parameters. Parameters discussed include standards, LOD, LOQ, precision and accuracy.

Laboratory Equipment Qualification

Lesson Code: PVL-700. Explains what is involved in laboratory equipment qualification. Includes DQ, IQ, OQ and PQ.

Analytical Laboratory - Practices

Introduction to HPLC

Lesson Code: PPL-830. Describes the basic theory and practice of HPLC. Particular focus is given to reverse phase HPLC. The components of a HPLC are described in detail and significant consideration is given to the explanation of results and peak shape. Analytical considerations of special relevance to HPLC are also presented.

HPLC Troubleshooting

Lesson Code: PPL-831. Describes the troubleshooting of common HPLC equipment problems. Examples include leaks, column frit blockages, baseline noise and detector malfunctions. The Lesson also describes the approach to troubleshooting these commonly encountered problems, and will be an invaluable resource to anyone working with HPLC on a regular basis.

Weighing

Lesson Code: PPL-500. The importance of good weighing techniques to analytical results. The main types of balances used in the laboratory and procedures for their use.

Glassware

Lesson Code: PPL-501. Choosing the correct glassware for preparing and storing solutions in the laboratory. How to read and use volumetric glassware correctly.

Solution Preparation

Lesson Code: PPL-1202. How to accurately prepare quantitative solutions from solids and liquids. This includes organization of work area, choosing correct grade of materials, quantitative transfer, dissolving solids and topping up.

Understanding Dissolution

Lesson Code: PPL-710. The influence of pH, temperature and stirring on how well a solid will dissolve in a liquid. How a drug dissolves in the human body and how in vitro dissolution testing can be used.

In Vitro Dissolution

Lesson Code: PPL-711. The stages of in vitro dissolution testing and the equipment used.

Dissolution Equipment Set-Up

Lesson Code: PPL-712. How to prepare dissolution media, standards, apparatus and sampling equipment prior to dissolution testing.

Dissolution Testing

Lesson Code: PPL-713. How to program the dissolution equipment, carry out media temperature checks, add dosage forms and remove samples. How to calculate dissolution results and when to retest.

Microbiology Laboratory - Practices

Principles of Good Aseptic Technique

Lesson Code: PPM-700. The importance of good aseptic technique and the major steps involved in applying it to microbiological testing.

Basic Microbiological Techniques

Lesson Code: PPM-710. The techniques used frequently by microbiologists including media preparation, pure culture techniques and the pour plate technique.

Introduction to Microscopy

Lesson Code: PPM-711. The importance of microscopy in microbiology. The main components of a microscope and microscopic techniques.

Introduction to Staining

Lesson Code: PPM-712. How to prepare and heat fix a smear correctly. Introduction to three main categories of staining i.e. simple, differential and structural.

Staining Techniques

Lesson Code: PPM-713. Explains the different staining techniques commonly used in a microbiology laboratory.

Unknown Bacterial Identification

Lesson Code: PPM-730. Introduces the concept of unknown bacterial contamination and the morphological and cultural tests carried out to identify these unknowns.

Microbiology Laboratory - GMP

GMP for Microbiology

Lesson Code: PGM-700. The importance of GMP in a microbiology laboratory and the rules and guidelines for handling infectious material.

Nonclinical Laboratory Studies

GLP Introduction

Lesson Code: PGL-520. Describes what GLP is, the areas covered by GLP, where nonclinical laboratory studies fit into the overall drug approval process, why GLP was developed and the main GLP terms used.

GLP - Working in the Laboratory

Lesson Code: PGL-521. The function of the laboratory for nonclinical testing. Focus on GLP as it relates to sample receipt, preparing for testing, testing, recording of results, and result approval.