"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
GDocP – Good Documentation Practices
The GDocP – Good Documentation Practices – Training is designed as a classroom session and contains 5 lessons. We use practical case examples to provide insight in the practical application of GDocP. Questions are included to check understanding, and participants are encouraged to ask questions or share comments with the audience. Participants are welcomed to provide examples of “daily business documentation”, in order to discuss them during the session.
- Provides overall awareness about GDocP.
- Helps to understand why GDocP is important.
- Explains the application of Good Documentation Practices.
- Provides knowledge on how to generate regulatory compliant documents and records.
- What are Good Documentation Practices (GDocP)?
- Conventions in Documentation
- Signatures and Electronic Signatures
- Completing Documentation Correctly
- Knowledge-Check / Exam
Who should attend:
All individuals who have a direct or potential impact on the documentation related to products and processes (= the Quality Management System).
Evidence of Completion:
Each participant will have the option to complete a final knowledge-check where 80% of the answers must be correct to get an Evidence of Completion Certificate. Each participant will receive a Certificate of Attendance.
This course does not cover US FDA 21 CFR Part 11 compliance or technical writing skills.
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 »
Bring 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.
Pharmaceuticals and Medical Device
Mr. Joachim Paap
Date, location and venue:
28 May 2019, Copenhagen CANCELLED
This course is offered in-house.
Click here for more info and inquiry form.
08.30-16.30 (Registration 08.00-08.30)
7 830 DKK (€ 1 050)
incl. course material (pdf), lunch 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 for the same course we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
Quantity disconts can not be combined with other discounts or offers.
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.
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.