Combination Products (Drugs, Devices & Biologics) – Part 2
Description: This course will provide an in-depth explanation of combination products, including regulatory definitions,...
Course Code: ELM-146
by: Graham O'Keeffe
Macro-learning
How Deviations (Non-Conformance’s) Should be Handled from a Regulatory Perspective
Description: This course focuses on defining the term deviation (nonconformance) and further discusses the...
Course Code: ELM-712
by: Graham O'Keeffe
Macro-learning
An Introduction to Good Manufacturing Practices (cGMP)
Description: Good Manufacturing Practices (GMP) are a set of principles that systematically minimize risks...
Course Code: ELM-722
by: Graham O'Keeffe
Macro-learning
Pharmaceutical Microbiology and Industry Considerations
Description: This course focuses on defining pharmaceutical microbiology and includes further discussion on microbial...
Course Code: ELM-711
by: Graham O'Keeffe
Macro-learning
The Basic Principles of Isolator Technology
Description: As technology is transforming from conventional clean room concept to barrier technology for...
Course Code: ELM-707
by: Graham O'Keeffe
Macro-learning
An Introduction to Good Clinical Practices (cGCP) – Part 1
Description: Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided...
Course Code: ELM-901
by: Graham O'Keeffe
Macro-learning
How to Write an Effective Equipment User Requirement Specification (URS)
Description: User requirements should be the starting point of any project you are working...
Course Code: ELM-127
by: Graham O'Keeffe
Macro-learning
Introduction to Risk Based Equipment Qualification
Description: This course describes how to assess the risks to product quality in the...
Course Code: ELM-121
by: Graham O'Keeffe
Macro-learning