Go Back

COURSE ID 2900

Computer System Validation and Part 11 Compliance

AVAILABLE On-demand
90 Minutes

On-Demand

Offering Price
$ 295
Register Now

You will be redirected to our secure system.

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

Learn more

Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

ACCREDITATION CEU's - 0.2 IACET
View Course Outline

Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.

This 90-minute accredited ON DEMAND training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing.

These vendors are not regulated, and therefore, this course will enable regulated companies to ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters.

who should
attend?

LEVEL
Introductory
INTERESTS
Biotechnology / Biopharmaceutical Cosmetics / Personal Care & Skin Care Medical Devices / Diagnostics Pharmaceutical Science & Technology

This course is intended for professionals from the Pharmaceutical, Biologics, Medical Device and related industries who work in the following areas:

– Quality Assurance/Quality Control

– Project Management

– Information Technology

– System Validation

– Engineering

– Manufacturing

Anyone from the above departments that enters data in a computer system, that pulls reports from a computer system, that operates equipment that stores data, engineers, QA and QC analysts, equipment operators, maintenance personnel will find this course beneficial.

 

 

course instructor

Joy McElroy
Consultant to the Pharmaceutical and Biotech Industries

Joy McElroy’s Courses
Joy McElroy, has 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies. Ms. McElroy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2019 Ms McElroy started her own company, McElroy Training and Consultancy. She currently works with Easi.

related courses

90 Minutes

The QbD Toolbox: Resources That Help New QbD Programs

12 Hours

Cosmetic Ingredients: From Science to Practical Use

90 Minutes

Best Practices for Investigation Deviations and Non-Conformances

90 Minutes

Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations