20. November 2017 til 21. November 2017

Kursus: 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 organized under license agreement with Key2Compliance®

- and are subject to any copyright

Course description / Who should attend:

This course focuses on GMP requirements as they relate to CS, as well as interpretations of and compliance with these requirements. The course is aimed at QA staff and anyone else involved in qualifying/validating CS. The course is also suitable for support staff with a need to familiarize themselves with the IT-specific GMP requirements.

Participation prerequisites

Basic training/knowledge in GMP / Quality systems.
You should have at least 6-12 months experience from working in GMP regulated industry.

If you are uncertain about your level of basic GMP knowledge, you can buy and take an online test here »

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

Anna Lundén, training director and part owner, Key2Compliance® and Henrik Johanning, CEO Genau & More discuss tendencies and developments to be found in observations and warning letters.

Genau Talks er en række videoer, der stiller skarpt på spørgsmål og tendenser indenfor compliance. Dem vil vi gerne dele med dig.

Underviser

Peter Nyborg

Sprog

English

Kursusdato

20. November 2017 til 21. November 2017

Lokation

DGI-byen

Tietgensgade 65

1704 København V

Kontakt os

For yderligere information kontakt underviser Peter Nyborg

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