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Consulting & Auditing

Virtual Instructor-Led Classes

Virtual Instructor-Led Classes

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Consulting

Description here

Training Courses

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!
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.

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. 

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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