Alphabetical Index of e-Lessons:

A

Analytical Laboratory GMP

Analytical Laboratory - Method Validation Parameters

Analytical Laboratory Practices - Glassware

Analytical Laboratory Practices - Introduction to HPLC

Analytical Laboratory Practices - Instrumentation - Error Prevention

Analytical Laboratory Practices - HPLC Troubleshooting

Analytical Laboratory Practices - Solution Preparation

Analytical Laboratory Practices - Weighing

Analytical Laboratory Practices - Wet Chemistry

API Contamination Prevention (Basic GMP)

API - Dress Codes for API Manufacturing (Basic GMP)

API Manufacturing - Chemical Reactions - Overview

API Manufacturing - Chemical Reactions - Properties

API Manufacturing - Chemical Reactor Design

API Manufacturing - Crystallization

API Manufacturing - Centrifuges

API Manufacturing - Distillation and Reflux

API Manufacturing - Drying

API Manufacturing - Filtration

API Manufacturing - Process Flow Diagrams

API Manufacturing - Pumps - Reciprocating Pumps

API Manufacturing - Pumps - Rotary and Centrifugal Pumps

API Manufacturing - Valves

API Manufacturing - Validation - Fundamentals of Process Validation

API Manufacturing - Water Types and Testing

API Manufacturing - Water Impurities and Treatment

API Manufacturing - Working with Reactors

API - Records for API Manufacturing (Intermediate GMP)

API - SOPs for API Manufacturing (Intermediate GMP)

Aseptic Processing - Cleanroom Rules, Control Parameters and Testing

Aseptic Processing - Introduction - Basic Microbiology

Aseptic Processing - Introduction - HVAC and Cleanrooms

Aseptic Processing - Introduction - Isolators

Aseptic Processing - Cleanroom GMP - Cleanrooms and Control Technologies

Aseptic Processing - Cleanroom GMP - Concepts and Controls

Aseptic Processing - Cleanroom GMP - Contamination Control

Aseptic Processing - Cleanroom GMP - Decontamination and Sterilization Technologies

Aseptic Processing - Cleanroom GMP - Gowning

Aseptic Technique - Principles - Microbiology Laboratory

Atypical Results - Out Of Specification (OOS) - Analytical Laboratory

Autoclaves - Moist Heat Sterilization

B

Biopharma Manufacturing - Bioreactors in Bioprocessing

Biopharma Manufacturing - Biotechnology and Biopharmaceuticals - Overview

Biopharma Manufacturing - Cell Biology - Recombinant DNA Technology

Biopharma Manufacturing - Cell Culture

Biopharma Manufacturing - Clean In Place

Biopharma Manufacturing - Downstream Processing - Centrifugation

Biopharma Manufacturing - Downstream Processing - Protein Purification - Chromatography

Biopharma Manufacturing - Downstream Processing - Ultrafiltration and Diafiltration

Biopharma Manufacturing - Fermentation

Biopharma Manufacturing - Formulation

Biopharma Manufacturing - Freeze Drying - Lyophilization

Biopharma Manufacturing - Overview

Biopharma Manufacturing - Process Validation - Process Design

Biopharma Manufacturing - Process Validation - Process Qualification and Control

Bioreactors - Biopharma Manufacturing - Bioprocessing

Blending - Finished Dose - Equipment

Buildings and Facilities (Intermediate GMP)

C

CAPA - CAPA for Nonconformities

Cell Biology and Recombinant DNA - Biopharma Manufacturing

Cell Culture - Biopharma Manufacturing

Centrifuges - API Manufacturing

Centrifugation - Downstream Processing - Biopharma Manufacturing

CFR - Introduction to 21 CFR Part 11

Chemical Laboratory Waste - Laboratory Health and Safety

Chemical Reactions (Overview) - API Manufacturing

Chemical Reactions (Properties) - API Manufacturing

Chemical Reactor Design - API Manufacturing

Chromatography - Downstream Processing - Purification - Biopharma Manufacturing

Cleaning of Equipment - Pharma GMP (Intermediate GMP)

Clean In Place - Biopharma Manufacturing

Cleanrooms and Control Technologies - Cleanroom GMP - Aseptic Processing

Cleanrooms and HVAC - Aseptic Processing - Introduction

Cleanroom GMP - Concepts and Controls - Aseptic Processing

Cleanroom GMP - Contamination Control - Aseptic Processing

Cleanroom GMP - Decontamination and Sterilization Technologies - Aseptic Processing

Cleanroom GMP - Gowning - Aseptic Processing

Cleanroom Rules, Control Parameters and Testing - Aseptic Processing - Introduction

Clinical Trials - GCP Essential Documents - Study Protocol - Investigator's Brochure

Clinical Trials - GCP - Anatomy of a Clinical Trial

Clinical Trials - GCP Inspection Readiness - Phase I - Initiate

Clinical Trials - GCP Inspection Readiness - Phase II - Plan - Handling Audit Questions

Clinical Trials - GCP Inspection Readiness - Phase III - Execute and Monitor

Clinical Trials - GCP Inspection Readiness - Phase IV - Close

Clinical Trials - New Drug Development

Clinical Trials - Roles and Responsibilities under ICH GCP

Coater - Finished Dose Equipment - Tablet Coater

Computer Systems - GxP Computerized Systems Validation (CSV)

Computer Systems - Introduction to 21 CFR Part 11

Computer Systems - IT Use in Regulated Industries (Computer Use and Validation)

Contamination Control - Cleanroom GMP - Aseptic Processing

Contamination Prevention - API (Basic GMP)

Contamination Prevention - Finished Dose (Basic GMP)

Crystallization - API Manufacturing

D

Data Integrity - Data Integrity for GxP Regulated Industries

Decontamination and Sterilization Technologies - Cleanroom GMP - Aseptic Processing

Diafiltration - Downstream Processing - Ultrafiltration - Biopharma Manufacturing

Distillation and Reflux - API Manufacturing

DNA - Recombinant DNA - Biopharma Manufacturing - Cell Biology

Downstream Processing - Centrifugation - Biopharma Manufacturing

Downstream Processing - Protein Purification - Chromatography - Biopharma Manufacturing

Downstream Processing - Ultrafiltration and Diafiltration - Biopharma Manufacturing

Dosage Forms - Solid Dosage

Dress Codes for API Manufacturing (Basic GMP)

Dress Codes for Finished Dose Manufacturing (Basic GMP)

Drug Development - Clinical Trials

Dryers - Finished Dose - Equipment

Drying - API Manufacturing

E

Equipment - Cleaning of Equipment (Intermediate GMP)

Equipment Qualification - Laboratory

Errors in GMP Manufacturing

Executive Responsibility in Pharma Manufacturing

F

Facilities - Buildings and Facilities (Intermediate GMP)

Fermentation - Biopharma Manufacturing

Filtration - API Manufacturing

Filtration - Finished Dose

Filtration - Sterile Filtration - Sterilization

Finished Dose - Contamination Prevention (Basic GMP)

Finished Dose - Dress Codes for Finished Dose Manufacturing (Basic GMP)

Finished Dose - Processes - Semisolid Dosage

Finished Dose - Processes - Solid Dosage Forms

Finished Dose - Process Flow Diagrams

Finished Dose - Equipment - Blending

Finished Dose - Equipment - Dryers

Finished Dose - Equipment - Filtration for Finished Dose

Finished Dose - Equipment - Fluidized Bed

Finished Dose - Equipment - Milling

Finished Dose - Equipment - Tablet Press

Finished Dose - Equipment - Tablet Coater

Finished Dose - GMP for Finished Dose Manufacturing (Basic GMP)

Finished Dose - GMP - Records in Finished Dose Manufacturing (Intermediate GMP)

Finished Dose - GMP - SOPs in Finished Dose Manufacturing (Intermediate GMP)

Finished Dose - Validation - Fundamentals of Process Validation

Finished Dose - Water Types and Testing

Finished Dose - Water Impurities and Treatment

Fluidized Bed - Granulation - Finished Dose Equipment

Formulation - Biopharma Manufacturing

Freeze Drying - Lyophilization - Biopharma Manufacturing

G

Gas Sterilization

GCP - Anatomy of a Clinical Trial

GCP - Essential Documents - Study Protocol - Investigator's Brochure

GCP Inspection Readiness - Clinical Trials - Phase I - Initiate

GCP Inspection Readiness - Clinical Trials - Phase II - Plan - Handling Audit Questions

GCP Inspection Readiness - Clinical Trials - Phase III - Execute and Monitor

GCP Inspection Readiness - Clinical Trials - Phase IV - Close

GCP - New Drug Development and Clinical Trials

GCP - Roles and Responsibilities under ICH GCP

Glassware - Analytical Laboratory Practices

GLP - Introduction - Nonclinical Laboratory Studies

GMP - API Contamination Prevention (Basic GMP)

GMP - API - Dress Codes for API Manufacturing (Basic GMP)

GMP - Buildings and Facilities (Intermediate GMP)

GMP - Cleaning of Equipment (Intermediate GMP)

GMP - Executive Responsibility in Pharma Manufacturing

GMP - Errors in GMP Manufacturing

GMP - Finished Dose Contamination Prevention (Basic GMP)

GMP - Finished Dose Manufacturing (Basic GMP)

GMP - Finished Dose Manufacturing - Dress Codes (Basic GMP)

GMP - GMP Goals (Basic GMP)

GMP - Inspections - Inspection Readiness - Interacting with the Inspector

GMP - Laboratory - Analytical Laboratory GMP

GMP - Laboratory - GMP for the Microbiology Laboratory

GMP - Personnel and Training (Intermediate GMP)

GMP - Pharmaceutical Manufacturing - Overview (Basic GMP)

GMP - Regulation of the Pharmaceutical Industry (Basic GMP)

GMP - Records for API Manufacturing (Intermediate GMP)

GMP - Records in Finished Dose Manufacturing (Intermediate GMP)

GMP - Sampling (Intermediate GMP)

GMP - SOPs for API Manufacturing (Intermediate GMP)

GMP - SOPs in Finished Dose Manufacturing (Intermediate GMP)

GMP - Warehousing (Intermediate GMP)

Gowning - Cleanroom GMP - Aseptic Processing

Granulation - Fluidized Bed - Finished Dose

GxP - Computerized Systems Validation (CSV)

H

Health and Safety - Laboratory - Chemical Laboratory Waste

Health and Safety - Laboratory - Safe Work Practices

Health and Safety - Microbiology Laboratory - General Safety Hazards

HPLC - Analytical Laboratory Practices - Introduction

HPLC Troubleshooting - Analytical Laboratory Practices

HVAC and Cleanrooms - Aseptic Processing - Introduction

I

ICH GCP - Clinical Trials - Roles and Responsibilities

Inspection Readiness - GMP Inspections - Interacting with the Inspector

Inspection Readiness - GCP - Phase I - Initiate

Inspection Readiness - GCP - Phase II - Plan - Handling Audit Questions

Inspection Readiness - GCP - Phase III - Execute and Monitor

Inspection Readiness - GCP - Phase IV - Close

Instrumentation - Error Prevention - Analytical Laboratory Practices

Integrity - Data Integrity for GxP Regulated Industries

Investigator's Brochure - GCP Essential Documents - Study Protocol

Isolators - Aseptic Processing - Introduction

IT Use in Regulated Industries (Computer Use and Validation)

IT Systems - GxP Computerized Systems Validation (CSV)

IT Systems - Introduction to 21 CFR Part 11

J

K

L

Labeling - Packaging and Labeling

Labeling - Serialization - Product Tracking - Introduction

Labeling - Serialization - Four Level Serialization Structure

Labeling - Serialization - Serialization and the Supply Chain

Laboratory - Chemical Laboratory Waste - Laboratory Health and Safety

Laboratory Equipment Qualification

Laboratory GMP - Analytical Laboratory

Laboratory - GMP for the Microbiology Laboratory

Laboratory - GLP Introduction - Nonclinical Laboratory Studies

Laboratory - Out of Specification (OOS) and Atypical Results

Laboratory - Safety Hazards in the Microbiology Laboratory

Laboratory - Safe Work Practices

Lyophilization - Freeze Drying - Biopharma Manufacturing

M

Method Validation Parameters - Analytical Laboratory

Microbiology (Basic) - Aseptic Processing - Introduction

Microbiology Laboratory - GMP for the Microbiology Laboratory

Microbiology Laboratory - Practices - Basic Microbiological Techniques

Microbiology Laboratory - Practices - Introduction to Microscopy

Microbiology Laboratory - Practices - Principles of Good Aseptic Technique

Microbiology Laboratory - Safety Hazards

Microscopy - Introduction - Microbiology Laboratory - Practices

Milling - Finished Dose - Equipment

Moist Heat Sterilization - Autoclaves - Sterilization

N

Nonclinical Laboratory Studies - GLP Introduction

Nonconformities - CAPA for Nonconformities

O

Out of Specification (OOS) and Atypical Results - Analytical Laboratory

P

Packaging - Labeling and Packaging

Packaging - Primary Packaging

Packaging - Secondary and Tertiary Packaging

Personnel and Training - Pharma GMP (Intermediate GMP)

Pharmaceutical Manufacturing - Overview - (GMP Basic)

Pharmaceutical GMP - GMP Goals (Basic GMP)

Process Design - Process Validation - Biopharma Manufacturing

Process Flow Diagrams

Process Validation - Fundamentals

Process Validation - Process Design - Biopharma Manufacturing

Process Validation - Process Qualification and Control - Biopharma Manufacturing

Protein Purification - Downstream Processing - Chromatography - Biopharma Manufacturing

Pumps - Reciprocating Pumps - API Manufacturing

Pumps - Rotary and Centrifugal Pumps - API Manufacturing

Q

Qualification - Laboratory Equipment

R

Reactions - Chemical Reactions (Overview) - API Manufacturing

Reactions - Chemical Reactions (Properties) - API Manufacturing

Reactors - Chemical Reactor Design - API Manufacturing

Reactors - Working with Reactors - API Manufacturing

Recombinant DNA - Biopharma Manufacturing - Cell Biology

Records for API Manufacturing (Intermediate GMP)

Records in Finished Dose Manufacturing (Intermediate GMP)

Reflux and Distillation - API Manufacturing

Regulation of the Pharmaceutical Industry (Basic GMP)

S

Safety Hazards - Microbiology Laboratory

Safe Work Practices in the Laboratory

Sampling (Intermediate GMP)

Secondary Packaging

Semisolid Dosage - Finished Dose - Processes

Serialization - Four Level Serialization Structure

Serialization - Product Tracking - Introduction

Serialization - Product Tracking in the Supply Chain

Solid Dosage Forms - Finished Dose - Processes

Solution Preparation - Analytical Laboratory Practices

SOPs for API Manufacturing (Intermediate GMP)

SOPs in Finished Dose Manufacturing (Intermediate GMP)

Sterilization - Gas Sterilization

Sterilization - Moist Heat Sterilization - Autoclaves

Sterilization - Sterile Filtration

Sterilization Technologies and Decontamination - Cleanroom GMP - Aseptic Processing

Study Protocol - GCP Essential Documents - Investigator's Brochure

Supply Chain - Serialization - Product Tracking

T

Tablet Coater - Finished Dose - Equipment

Tablet Press - Finished Dose - Equipment

Tertiary Packaging

Tracking - Serialization and Product Tracking

Tracking - Serialization and the Supply Chain

Tracking - Serialization - Four Level Serialization Structure

Training - Pharma GMP Personnel and Training (Intermediate GMP)

U

Ultrafiltration - Downstream Processing - Diafiltration - Biopharma Manufacturing

V

Validation - Computerized Systems Validation (CSV)

Validation - Fundamentals of Process Validation

Validation - IT Use in Regulated Industries (Computer Use and Validation)

Validation - Method Validation Parameters - Analytical Laboratory

Validation - Process Design - Process Validation - Biopharma Manufacturing

Validation - Process Qualification and Control - Biopharma Manufacturing

Valves - API Manufacturing

W

Warehousing (Intermediate GMP)

Water Types and Testing - API and Finished Dose

Water Impurities and Treatment - API Manufacturing / Finished Dose Manufacturing

Waste - Chemical Laboratory Waste - Laboratory Safe Work Practices

Weighing - Analytical Laboratory Practices

Wet Chemistry - Analytical Laboratory Practices

Working with Reactors - API Manufacturing

X

Y

Z