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QA/RA Consulting, Auditing & Training

FDA 21 CFR Part 11 Training: Pharmaceutical Data Integrity, ALCOA+, and Electronic Records

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.

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Brief Overview of This Course on Data Integrity for Pharmaceutical Manufacturers

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Class Content

In-Depth

Class Duration

2 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

0.8

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered in 1 day.

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Training Classes on Part 11 Compliance for Pharma Manufacturers

SkillsLab $1495

SkillsLab $1495

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Class on Part 11 Compliance for Pharma Manufacturers

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 prescribed guidance.

Course Overview

SkillsLab Class

Regulatory Basis for Computer Systems and Applications

Regulatory requirements for quality management system (QMS) software systems and GxP
Risk-based approach for manufacturers
US FDA emphasis on computer system controls and data integrity

Data Integrity in Electronic Records

Regulatory focus on data integrity
21 CFR Part 11 electronic documents and records
Assessing software used in the QMS

Exercise! Assessing the QMS or PQS for Gaps

Exercise! Assessing Systems for GxP Applicability

Exercise! Assessing Part 11 Gaps

Implementation and Applications

Data integrity culture
Evaluating and controlling data
Implementing controls

Exercise! Evaluating Raw Data

Exercise! Assessing Systems

Preparing for Regulatory Review

Electronic records in regulatory submissions
Part 11 enforcement
Management and risk-based control of Part 11-compliant systems

What You Will Learn

At the conclusion of this training class, you will be able to

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Describe FDA 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.

Procedures Managers
Approvals Managers
Data Managers
RA/QA Professionals
Cross-Functional Team Members

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