13. December 2021 to 14. December 2021

Course: GMP requirements for Computer Systems & Data Integrity

A review of FDA and EU requirements and interpretations relating to computer systems (CS)

Course objective

The aim of the course is to increase participants’ knowledge of:

Existing GMP and EU requirements and interpretations relevant to CS
Validation of various types of CS, using a risk-based approach
Requirements and actual interpretations relating to Electronic Records and Electronic Signatures, based on 21 CFR, Part 11
Warning Letters issued in the area of Data Integrity and CS Validation
Data Integrity and IT Security

The courses are held in collaboration with Key2Compliance® - and subject to copyright

Prerequisites:

Basic training/knowledge in GMP / Quality systems.
You should have at least 6-12 months experience from working in GMP regulated industry.
You must have completed the basic course 4113se or have equivalent basic knowledge of GMP

If you are unsure of your GMP basic knowledge, you can buy and do an online test here:
» SmartGMP® (Trin 1)

Course content

Day 1 – THEME: General requirements/CS validation

Background for CS validation
Relevant GMP requirements, FDA
Relevant GMP requirements, EU
The “life-cycle model”, risk and CS testing
Off-the-shelf software
Presentation of validation information for the FDA and the EU

Day 2 – THEME: Part 11 – Electronic Records/Electronic Signatures (ER/ES)

Part 11 – Background and Scope
Archiving and copying of ER and ES
User Access – User Rights
Audit Trail, Operational checks and Device checks
ES

Day 2 – THEME: Data integrity

Background: Definition of Data Integrity (ALCOA)
IT Security
Protect your data!
Electronic Records or hardcopy?
IT behaviour
Examples of Data-Integrity Warning Letters
Wrap-up

Both course days also include a review of relevant warning letters.

Genau Talks

John Lee, Executive Director of Pharmaceutical Compliance Associates, and Henrik Johanning, CEO Genau & More discuss Computer Systems Validation and Part 11. When do you have electronic registrations and signatures and thus need to be in compliance with Part 11? When you press the enter button and you save data to a hard drive or USB drive, of course depending on whether or not you have to follow predicate rules (predicate rules interpreted as GMP).

Genau Talks is a series of videos that focuses on questions and tendencies within compliance. We would like to share these with you.

Tutor

Henrik Johanning

Language

English

Course date

13. December 2021 to 14. December 2021

Location

DGI Byen

Tietgensgade 65

1704 København V

Contact

For yderligere information kontakt underviser Henrik Johanning

Customized courses?

We offer courses based on your needs and equipment.

Our trainers have many years of experience in the pharmaceutical industry and have all participated in inspections and internal audits.

Find out more about the possibilities for you.

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