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Pharmaceutical RA/QA

Overview

Since 1977, Oriel STAT A MATRIX has been helping companies in FDA-regulated industries to achieve regulatory compliance throughout the product life cycle.

RA/QA training for pharmaceutical and combination products is now available.

Classes are available as in-person or virtual instructor-led trainings. Select a course to learn more or to register.
 
Course Name Public Private
New!   Applying Usability Principles to Drug Delivery Systems with IEC 62366-1:2020
New!   Combination Product Device Supplier Management Training
New!   Managing Risks in Combination Products and Drug Delivery Systems
New!   Validating Software used in Automated Pharmaceutical Manufacturing Processes
New!   Combination Products: From Regulatory Strategy to Postmarket Surveillance
New!   Process Validation in the Pharmaceutical Industry
New!   Data Integrity and Electronic Records Training for Pharmaceutical Companies (ALCOA+ and FDA 21 CFR Part 11)

This course provides an overview of the requirements of IEC 62366-1:2020, including the relationship with the risk management process.

This course will provide your organization with the knowledge and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system for your combination product. As part of this course, you will identify recommendations for writing quality agreements with contract manufacturing organizations (CMOs) and auditing.

 

Learn how to apply ISO 14971:2019 and ICH Q9 risk management from both a combination product focus and a process focus.

This course will provide your organization the knowledge and skills needed to meet the requirements for identifying, validating, and managing the life cycle of non-product software used in automated pharmaceutical manufacturing processes.

Receive an overview of combination products and explore the regulatory challenges of a product that combines a medical device with a drug and/or biologic. 

Get an in-depth look at the entire validation cycle in the pharmaceutical industry, writing protocols, determining key operating parameters, establishing ranges for critical quality attributes, and identifying data analysis strategies.

In this course, you will obtain the knowledge and practical application experience needed to ensure your devices and regulated IT systems maintain or exceed the high level of quality expected by FDA. 

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