GMP Documentation Training Course
On request!
Good Manufacturing Practice documentation is essential when you are working under GMP. In this course you will learn what the practices, requirements and (legal) guidelines are for pharmaceutical GMP documentation.
- Duration
- 2 day training course
- Course fee
- € 1700 (excl. VAT)
Short description
This course is only available for group registrations of 6 trainees or more. Please contact us at info@biotechtrainingfacility.nl to arrange a date.
What can you expect from this GMP Documentation Training?
Well written Good Manufacturing Practice documents ensure that procedures are understood and closely followed. They simplify the production of pharmaceutical products and QC analyses, reduce mistakes and improve the safeguarding of data integrity.
Constructing well written documents is a skill that needs to be trained. During this course you will learn how to write GMP documents through the use of practical examples. By alternating theory and practice, the theory is immediately practised and applied in practice!
The main focus is on writing procedures, work instructions, batch production records (BPRs) and analytical sheets - preformatted forms which are filled in during the execution of quality control tests.
The following documentation aspects will be part of the theoretical sessions:
- Purpose of GMP documents
- Information that should always be included in procedures, batch production records and analytical sheets
- Legal requirements for GMP documentation
Instructions for writing clear, unambiguous and easy-to-read documents
- Practical tips for drafting high-quality documents or increasing the quality of existing documents
- How to prevent a writer's block
Objectives
This GMP documentation course will increase awareness, skills and knowledge of the following topics:
- Importance of well written GMP documentation
- Legal requirements with regard to GMP documents
- Content requirements for writing procedures, batch production records (BPR), analytical methods and analytical raw data.
- Capability to write the following GMP documents: procedures, batch production records and analytical sheets.
Target group
Whho should follow this GMP documentation course?
- Quality Assurance (QA), Quality Control (QC) or Operations staff who are involved in writing, editing, reviewing and/or approve GMP documents.
- Management and staff who feel the need to increase their knowledge of quality documentation used for working under GMP
- Reviews of participants: "I would recommend this course because there are really good points being discussed and the knowledge is very high".
Program
Day 1
Documentation in GMP - Theory• GMP documentation requirements and guidelines |
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Documentation in GMP - Practice Within the context of pharmaceutical and biotech companies: |
Day 2
Documentation in GMP - Theory• Legal requirements for GMP documentation |
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Documentation in GMP - Practice in the context of the pharmaceutical and biotech industry: |
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Related courses
Interested in signing up a group of people for this course?
Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100
Need help? Have a question or a suggestion maybe?
Drop us a line below or call us on
+31 (0) 88 283 01 00.