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.
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Intro to Good Manufacturing Practices (GMPs) for Drugs & Medicinal Products
In this Compliance Training, learn about GMPs for Drugs and Medicinal Products in a specialized intro course designed by top industry experts.
Good Practice (GxP) in Drug Development and Manufacturing
Learn the basics of GxP for drug development and manufacturing in this compliance training designed by leading industry experts.
Cleaning and Sanitation GMPs (Good Manufacturing Practices)
Learn how to comply with Good Manufacturing Practices (GMPs) in proper cleaning and sanitation practices for the drug industry.
Warehouse GMPs (Good Manufacturing Practices)
Learn the requirements for drug and medicinal manufacturing warehouse GMPs in this compliance training crafted by leading industry experts.
Good Manufacturing Practices in Processing Medicinal Products
Learn the essentials in processing medicinal products according to proper GMPs in this compliance training designed by leading industry experts.
Packaging GMPs for Drugs & Medicinal Products
Learn packaging GMPs for drugs and medicinal products. Learn from leading industry experts in this self-paced compliance training.
Essentials of EU and US Regulatory Affairs for Human Medicinal Products
Learn about regulatory affairs in both the US and EU in this self-paced compliance training for Human Medicinal Products.
ANDA: How to Gain Approval to Market a Generic Drug in the USA
Learn the regulatory requirements for the Abbreviated New Drug Application (ANDA) and gaining approval to market a generic drug 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 in convenient compliance training.
Variations to Marketing Authorizations in Europe
Learn about variations to the drug marketing authorizations processes in Europe, a critical process in drug development.
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Understanding the Decentralized Procedure (DCP)
Learn about the Decentralized Procedure, a 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 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 4 pathways for applying for marketing approval in the US, with a focus on how/when to use the 505B2 application.
The European Centralized Procedure (CP)
Learn about the Centralized Procedure (CP), a single application to the European Medicines Agency (EMA) in this Compliance Training.
Preparing Submissions in the Common Technical Document Format
Learn how to prepare Common Technical Document submissions in this Compliance Training created by leading industry experts.
Mutual Recognition Procedure (MRP)
Learn the essentials of Mutual Recognition Procedure in the pharmaceutical industry with this compliance training created by leading industry experts.
The Regulatory Pathway to Approval of Follow-on Biologics (Biosimilars) in the USA
Learn everything you need to know about follow-on biologics (biosimilars) in this compliance training created by leading industry experts.
Introduction to 21 CFR 11
Learn the essentials of the 21 CFR 11 and ensure your compliance with electronic records and signatures in this convenient compliance training.
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