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Data Integrity and Electronic Records Training for Pharmaceutical Companies (ALCOA+ and FDA 21 CFR Part 11)

 

Provide FDA with what it expects by learning how to maintain electronic records, electronic signatures, and the data integrity of software systems.

FDA is changing its approach to regulating software in quality systems. Simply following their guidance has not been enough for the pharma industry to guarantee the high quality of systems that FDA expects. Manufacturers will now be responsible for determining their own controls and justifying their effectiveness to regulators rather than following explicitly proscribed guidance.

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. This course specifically focuses on appropriately maintaining electronic records, electronic signatures, and the data integrity of software systems used in the pharmaceutical industry.

 

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) 11/01/2022 2 $1495.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 03/02/2023 2 $1495.00 Add to Cart CONTACT US

What Will You Learn

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

  • Describe 21 CFR Part 11 requirements for electronic records and signatures
  • Describe US regulatory expectations and guidance for data integrity ALCOA+
  • Examine how to implement risk-based and critical thinking to apply the best approach to a specific system

 

Who Should Attend

Anyone in a pharma organization responsible for managing procedures, approvals, and data in electronic form. All RA/QA professionals and other cross-functional team members.

 

Virtual Half-Days: 2
In-Person Full-Days: 1
CEUs: 0.8

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 two 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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