Laboratory (Analytical, Microbiology, Nonclinical)

Analytical Laboratory - GMP

Out of Specification & Atypical Results

Lesson Code: PGL-1200. This e-Lesson is aimed at personnel who require an overview of 'Out Of Specification' (OOS) and Atypical Results in the analytical laboratory, including how they are investigated, and how they can be prevented.

 

Laboratory GMP

Lesson Code: PGL-1210. This e-Lesson is aimed at personnel who require knowledge of analytical laboratory GMP requirements and, in particular, how these requirements relate to the role of the laboratory analyst.

 

Laboratory Information Management System (LIMS)

Lesson Code: PGL-1206. This e-Lesson is aimed at personnel who require an overview of the purpose and mode of operation of a Laboratory Information Management System (LIMS), with a focus on how samples are processed, from initial receipt in the laboratory through approval of results and batch release.

 

Analytical Laboratory - Validation

Method Validation Parameters

PVL-1210. This e-Lesson is aimed at personnel who require an overview of method validation in the analytical laboratory, including why it must be performed and the various parameters that must be examined.

 

Laboratory Equipment Qualification

Lesson Code: PVL-1200. This e-Lesson is aimed at personnel who require an overview of Laboratory Equipment Qualification, why it is done, the stages and activities involved, and the key role of documentation and other support activities.

 

Analytical Laboratory - Practices

Introduction to HPLC

Lesson Code: PPL-1130. (PREMIUM LESSON) 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-1131. (PREMIUM LESSON) 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-1200. 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-1201. This e-Lesson is aimed at laboratory personnel who require an understanding of how to choose the correct glassware for preparing and storing solutions in the laboratory and 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.

 

Wet Chemistry

Lesson Code: PPL-1206 This e-Lesson is aimed at analytical laboratory personnel who require an overview of necessary wet chemistry skills including use of pipettes and burettes, quantitative transfer of materials, and making dilutions.

 

Instrumentation - Error Prevention

Lesson Code: PPL-1205. This e-Lesson is aimed at analytical laboratory personnel who require an overview of common errors associated with using spectrometry (AA, UV/VIS, IR) and pH measurement techniques and how these errors can be avoided.

 

Understanding Dissolution

Lesson Code: PPL-1210. This e-Lesson is aimed at personnel who require an overview of dissolution testing, including the factors that affect dissolution, and how a solid dosage drug form is absorbed into the bloodstream. 'In Vivo' and 'In Vitro' analyses are explained and typical 'In Vitro' dissolution tests are described.

 

In Vitro Dissolution

Lesson Code: PPL-1211. This e-Lesson is aimed at personnel who require an overview of how in vitro dissolution is performed in the laboratory. The various stages of the dissolution testing process are described along with the components of a dissolution apparatus and the equipment used for both manual and automatic sampling.

 

Dissolution Equipment Set-Up

Lesson Code: PPL-1212. This e-Lesson is aimed at personnel who require an overview of how solutions and equipment are prepared for a dissolution process. It includes the preparation of media and typical dissolution apparatus setup checks that are performed. Manual and automatic sampling operations are also included.

 

Dissolution Testing

Lesson Code: PPL-1213. This e-Lesson is aimed at personnel who require an overview of how dissolution testing is performed in practice. It includes setting of operational parameters, preparation and addition of dosage forms, sampling, generation and treatment of data, and checking of results against specifications. Criteria for retesting are also explained.

 

Microbiology Laboratory - Practices

Principles of Good Aseptic Technique

Lesson Code: PPM-1200. The importance of good aseptic technique and the major steps involved in applying it to microbiological testing.

 

Basic Microbiological Techniques

Lesson Code: PPM-1210. This e-Lesson is aimed at personnel who require an overview of techniques frequently used in microbiology laboratories including media preparation, handling stock cultures, and pure culture techniques.

 

Introduction to Microscopy

Lesson Code: PPM-1211. This e-Lesson is aimed at personnel who require an overview of microscopy in microbiology, including microscope components and functions, different lens types, and various microscopy techniques.

 

Introduction to Staining

Lesson Code: PPM-1212. This Lesson is aimed at personnel who require an overview of bacterial staining, including how to prepare a good bacterial smear on a glass slide, how to fix bacterial smears, and the different categories of bacterial stains.

 

Staining Techniques

Lesson Code: PPM-1213. This e-Lesson is aimed at personnel who require an overview of the techniques used to stain and identify organisms. The types of staining dyes used are detailed and a number of staining techniques are explored, namely: Simple Staining, Negative Staining, Gram Staining, Acid-Fast Staining, and Spore Staining.

 

Unknown Bacterial Identification

Lesson Code: PPM-1230. This Lesson is aimed at personnel who require an overview of the laboratory techniques commonly used to determine the morphological and cultural characteristics of unknown bacteria.

 

Microbiology Laboratory - GMP

GMP for Microbiology

Lesson Code: PGM-1200. This e-Lesson explores "why" and "how" GMP is applied in the microbiology laboratory in areas such as handling of samples, preparing work areas, labeling items, and dealing with spills.

 

Nonclinical Laboratory Studies

GLP Introduction

Lesson Code: PGL-1220. 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-1221. This e-Lesson is aimed at personnel who require an explanation of GLP requirements for nonclinical studies and, in particular, how these requirements affect the role of an analyst.