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Managing Risks in Combination Products and Drug Delivery Systems

Learn how to apply ISO 14971:2019 and ICH Q9 risk management from both a combination product focus and a process focus. The course also discusses how to select and apply risk management tools through all phases of a combination product’s life cycle. Use the course to keep up to date on global regulations and trends in risk management.
 
 
 
 

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (Eastern Time) 11/14/2022 5 $3295.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 02/13/2023 5 $3295.00 Add to Cart CONTACT US

What You Will Learn

At the end of this workshop, you will be able to:

  • Identify integration of risk into the US FDA Quality System Regulation (QSR)
  • Identify similarities between the ICH series and ISO 13485 in quality risk management
  • Describe the key concepts of ISO 14971 and ISO/TR 24971, including the definitions for benefit, state of the art, and reasonably foreseeable misuse, and the expanded requirements for production and postproduction activities
  • Describe the risk management process, including planning, analysis, evaluation, control, benefit-risk, and residual risk analysis, risk management review and reporting, and production and postproduction activities
  • Identify production and postproduction risk management requirements, including corrective and preventive action (CAPA) activities and postmarket surveillance processe
  • Describe how to use the process and risk-based approach of ISO 13485 and ICH Q9 to ensure the continued suitability, adequacy, and effectiveness of your risk management process
  • Apply risk management to product safety using ISO 14971 by creating a risk management plan, applying tools for risk assessment and risk control, conducting a benefit-risk analysis, and creating a risk management report
  • Describe the key concepts of ISO 14971 and ISO/TR 24971, including the definitions for benefit, state of the art, and reasonably foreseeable misuse, and the expanded requirements for production and postproduction activities

Who Should Attend

Anyone from the pharmaceutical and medical device industry involved in development of combination products, including regulatory personnel. Recommended for design managers and engineers; manufacturing, service, quality assurance, reliability, research and development, internal auditors, and regulatory affairs professionals; and other cross-functional team members in combination product manufacturing. All attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485.

Virtual Half-Days: 5
In-Person Full-Days: 3
CEUs: 2.4

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:00-5:00 p.m. ET. Seminars run on Eastern Time unless otherwise noted in the Location field.

Auditor classes that require a final exam start at 11:30 a.m. on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

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