Drug Compliance Training
Achieve Excellence in Pharmaceutical Regulatory Standards
Gain critical knowledge in FDA compliance, GMPs, and drug safety protocols. Our comprehensive training prepares you for every step of drug development, manufacturing, and market approval.
Variations to Marketing Authorizations in Europe
Learn about variations to drug marketing authorization processes in Europe.
The Regulatory Pathway to Approval of Follow-on Biologics (Biosimilars) in the USA
Learn about the regulatory pathway to approval of Follow-on Biologics (Biosimilars) in the US.
The New Drug Application (NDA) for Marketing Approval in the USA
Learn the requirements to submit a New Drug Application (NDA) for Food and Drug Administration (FDA) approval
Mutual Recognition Procedure (MRP)
Learn when and how to use the Mutual Recognition Procedure (MRP) for medicinal products.
The European Centralized Procedure (CP)
Learn about the Centralized Procedure (CP), a single application to the European Medicines Agency (EMA)whose goal is to obtain marketing authorization in member states of the European Economic Area (EEA)
The Decentralized Procedure (DCP)
Learn about the process that permits the authorization of medicinal products in participating European countries.
The Biologics License Application (BLA) for Marketing Approval in the USA
Learn how to complete a Biologics License Application (BLA) to request the Food and Drug Administration (FDA) to license the sale and marketing of a biological product in the US.
The 505(b)(2) Application for Marketing Approval in the USA
Learn the scenarios in which to use a 505(b)(2) New Drug Application and their pathways.
Preparing Submissions in the Common Technical Document Format
Learn how to prepare the Common Technical Document for marketing authorization applications
Intro to Good Manufacturing Practice for Medicinal Products
Learn how to use Good Manufacturing Practices for medicinal products to protect and uphold the quality of products and the health of consumers.
Good Practice GxP in Drug Development and Manufacturing
Learn good practices for drug development and manufacturing in this entry-level course.
How to Gain Approval to Market a Generic Drug in the USA
Learn the regulatory requirements for gaining approval to market a generic drug in the US.
Good Manufacturing Practice in Processing Medicinal Products
Learn how to perform processing operations that comply with Good Manufacturing Processes for medicinal product manufacturing
Good Manufacturing Practice in Packaging Medicinal Products
This course provides essential training for all personnel who work on the packaging of medicinal products. Other staff working in a manufacturing environment in the pharma/biotech industry will also benefit from this module.
Good Manufacturing Practice in Cleaning and Sanitation
Learn to comply with Good Manufacturing Practices by reducing contamination with proper cleaning and sanitation practices for the drug industry.
Good Manufacturing Practice for the Warehouse
Learn the requirements for complying with Good Manufacturing Practices in a medicinal manufacturing warehouse setting.
Essentials of EU and US Regulatory Affairs for Human Medicinal Products
Learn about regulatory affairs in both the US and EU. Solidify the key topics by participating in challenges and answering sample questions.
Introduction to 21 CFR 11
Learn about Part 11 of Title 21 of the Code of Federal Regulations, which establishes the United States Food and Drug Administration (FDA) regulations for electronic records and electronic signatures.
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