"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
GMP requirements for Computer Systems
& Data Integrity
A review of FDA and EU requirements and interpretations relating to computer systems (CS).
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.
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
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
Both course days also include a review of relevant warning letters.
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
- 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 »
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »
This course in-house?
Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?
If so, running the course in-house is probably the best and most cost effective solution.
US and EU
Mr. Peter Nyborg
Date, location and venue:
November 20-21, 2017, Copenhagen, Denmark
(Entrance from Kvægtorvsgade)
This course is also offered in-house.
Click here for more info and inquiry form.
9.00-16.30 (Registration 08.30-09.00)
10 900 DKK (€ 1 460) incl. course material (pdf), lunches and refreshments
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.
For groups registered and invoiced together we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
We do not offer or practice any general company discounts without commitments and/or written agreements.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
* If you still want a printed course handouts binder from us, we charge 50 Euro/pcs (of which 10 Euro to TRINE for clean energy projects)
Cancellation of registration:
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.
Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.