Validation of Analytical Laboratory Procedures
This course introduces developers and those individuals involved in validation of analytical methods to the regulatory requirements for the validation of analytical laboratory procedures. After taking...
View ArticleHow to Meet Drug Retention & Stability Testing Requirements
This course is designed to provide the learner with an understanding of the principles of drug stability testing and requirements for maintaining reserve samples. The goal of this lesson is for the...
View ArticleTour of Health Canada
Health Canada touches the lives of virtually every Canadian, every day. This special tour introduces participants to Health Canada's mission and organization. After the brief introduction, the tour...
View ArticleTour of Health Europe
The system in Europe for ensuring safe, effective, and high-quality health products is composed of national authorities in individual countries as well as bodies in the European Union and the Council...
View ArticleCollecting Samples & Establishing Limits for Cleaning Validation
GMP regulations require that the equipment and utensils used in the manufacturing of a drug, medical device, or biologic product be cleaned, maintained, and, as appropriate for the nature of the...
View ArticleQ9: Quality Risk Management
This course introduces the principles of quality risk management (QRM) developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human...
View ArticlePrinciples Sterilization
This course discusses the basic principles of several commonly used sterilization techniques: moist-heat, dry-heat, gas, radiation, chemical, and filtration. It also provides an introduction to the...
View ArticlePrinciples Sterilisation (EU)
This course discusses the basic principles of several commonly used sterilisation techniques: moist-heat, dry-heat, gas, radiation, chemical, and filtration. It also provides an introduction to the...
View ArticleOrientation GMP Compliance
Many people, including those who work in the drug and medical device industries, find regulations confusing. Because FDA regulations have a direct impact on how you do your job, this interactive...
View ArticleDesign & Development Software Used in Automated Process Controls
Both the pharmaceutical and medical device industries automate their manufacturing processes in order to make them more efficient, more accurate, and more consistent. As a result, the use of...
View ArticleUnderstanding GMP Requirements for Facilities & Equipment (EU)
Facilities and equipment GMP requirements impact many aspects of plant operation — from setup to maintenance and cleaning. This interactive programme introduces the general layout and equipment used...
View ArticleApproval Process for New Medical Devices
This course gives an overall view of the development process for admitting a new medical device into the marketplace.$99.95
View ArticleGood Clinical Practices (GCPs) New Product Investigations
This course helps the learner to understand the general requirements of Good Clinical Practice (GCP) and the protection of human subjects, as well as provide information regarding the concepts,...
View ArticleGMP Updates Supply Chain Quality
In this course, you will learn: why supply chain quality has evolved as a critical concern in the medical device and pharmaceutical industries, what challenges face these manufacturers, how regulators...
View ArticleISO 14971 Risk Management Medical Devices
This course is designed to provide you with an overview of the application of Risk Management activities for medical device product safety through implementing the ISO 14971 International Standard for...
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