3. December 2019 til 4. December 2019

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 held in collaboration with Key2Compliance® - and subject to 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 testhere »

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.

Underviser

Peter Nyborg

Sprog

English

Kursusdato

3. December 2019 til 4. December 2019

Lokation

Scandic Copenhagen

Vester Søgade 6

DK - 1601 Copenhagen

Kontakt os

For more information please contact tutor Peter Nyborg

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