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Compliance Seminars®

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GDocP – Good Documentation Practices

Course description:

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.

This course:

  • 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.

Course content:

  • What are Good Documentation Practices (GDocP)?
  • Conventions in Documentation
  • Falsification
  • Signatures and Electronic Signatures
  • Completing Documentation Correctly
  • Summary
  • 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.



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Course facts

Course no:
Pharmaceuticals and Medical Device


Joachim Paap
Mr. Joachim Paap

Date, location and venue:

Preliminary May/June 2020, Stockholm, Sweden

This course is offered in-house.
Click here for more info and inquiry form.

1 day
08.30-16.30 (Registration 08.00-08.30)

Price (excl. local VAT):
€ 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 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.

Course material (Handouts)  
No printed course material will be provided on our courses*.
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.
3-7 days prior the course you will receive a download link for the course handouts as a PDF.
Note pads and pens will always be provided at the venue.

Cancellation policy - Compliance Seminars®  

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 14 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.