Why Cleanroom Training?
Do you have staff new to the world of cleanrooms? Does your team need a refresher on cleanroom protocol, and specifically documentation processes? Are you seeing a high rate of product failures? Do you need to maintain compliance with EU-GMP regulations? Each operator has the power to reduce the risk to manufacturing processes, and so training from Angstrom Technology gives operators the tools and confidence to ensure their documentation process is always compliant.
Good Documentation Practice (GDocP) Training
Good documentation practices are required to comply with Good Manufacturing Practice (GMP and cGMP).
When operating a cleanroom, accurate and complete documentation is required to ensure traceability of all manufacturing and quality control testing activities. Not only this, having accurate documentation at all times allows regulatory inspectors and auditors to assess the overall quality of operations within a company and their final medicinal product.
The Good Documentation Practice course includes modules covering wide-ranging subjects, all with the aim of helping attendees understand what good documentation practice is, why it’s required and how non-compliance can impact the quality of end products.
Who is Good Documentation Practice (GDocP) Training For?
The course is intended for those responsible for the cleaning and/or maintenance of GMP cleanrooms, including but not limited to:
- GMP Cleanroom Operators
- GMP Cleanroom Supervisors and Managers
- GMP Quality Staff
- GMP Cleanroom Engineers
GMP Documentation Course Content
This informative course is predominantly theoretical and classroom based, and will include the following subject areas:
- What is Good Documentation Practice?
- Why and where is Good Documentation Practice important?
- ALCOA+
- Corrections
- Dates and times
- Recoding data
- Rounding
- Electronic data
- Dos and don’ts
- What to do when Good Documentation Practice isn’t followed
- Assessment
Learning Outcomes
The learnings to take away from the GMP Documentation course will be to understand what Good Documentation Practice is, why it is required, how it impacts your role and how non-compliance could impact the quality of the final product.
Training can be conducted in person or online for your convenience.
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Our cleanroom training courses are designed to help users control the introduction, generation and retention of particles in line with EU GMP and ISO 14644 standards. You can choose from one of our popular courses or we can create tailored cleanroom courses and structure the modules to suit your requirements.
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