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FDA renews training contract for 2025

in-person

Mar 16, 2026

Hands-On Essentials of Automation for Biomanufacturing

Obtain knowledge and hands-on experience with industry-relevant process control instrumentation, hardware, and software, and documentation for control/automation of biomanufacturing operations. Engage in hands-on experiences with process sensors/equipment and their integration…

Mar 16, 2026

Artificial Intelligence in FDA-Regulated Manufacturing: From Foundations to Implementation

This intensive hands-on workshop bridges the gap between AI capabilities and regulatory reality in life sciences manufacturing. Participants will gain practical knowledge of how large language models work, learn to…

Mar 16, 2026

PAT for Real-time Culture Monitoring and Closed-Loop Process Control

In this three-day, hands-on course, you will gain familiarity with and applied insight into the functionality of control equipment and instrumentation, and how to integrate Process Analytical Technology (PAT) into…

Mar 16, 2026

Applied Principles and Techniques of Depth Flow Filtration (DFF) and Tangential Flow Filtration (TFF) for BioPharm Purification

By participating in this comprehensive four-day filtration course, you will gain a solid understanding of the core principles and best practices for both depth filtration (DFF) and tangential flow filtration…

Mar 16, 2026

Cell Culture Engineering

Learn key concepts and practical skills in bioprocess development and cell culture engineering in biomanufacturing. Lectures focus on cell culture media and feeding strategies, operational modes (batch, fed-batch, perfusion), bioreactor…

Mar 16, 2026

Design of Experiments for Biomanufacturing

This workshop aims to introduce participants to the principles and applications of Design of Experiments (DoE) in the analysis of bioprocesses. Through a combination of lectures, hands-on use of JMP…

Mar 16, 2026

Hands-On Biomanufacturing of Vectors for Gene Therapy

Obtain hands-on training in the production of vectors for gene therapy products using an AAV2-GFP model system in both HEK293 cells and Sf9/Baculovirus systems. Engage in pilot/manufacturing-scale upstream operations (adherent…

Mar 16, 2026

Hands-On CGMP Biomanufacturing Operations

Obtain a basic knowledge of biomanufacturing operations and how CGMP requirements are implemented at commercial scale. Engage in pilot-scale laboratory experiences that examine process utilities, media and solution preparation, bioreactor…
Participants operate the control panel of a 30 L bioreactor.

Sep 19, 2024

FDA renews training contract for 2025

Continuing a program that began in 2008, the U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) has renewed its training contract with BTEC for 2025. From March to…