GMP for Quality Control for Pharmaceuticals
GMP for Quality Control for Pharmaceuticals
Basic Level | Course | English | Pharma | 57 minutes
Corresponds to ½ day of teacher-directed learning
Description
This introductory course provides a basic understanding of Good Manufacturing Practice for Quality Control Laboratories in the pharmaceutical industry. You'll learn about the role and responsibilities of the QC organisation at a manufacturing site and you will get a broad understanding of work procedures, authorities' expectations, and best practices within the QC area.
The course includes a high-level overview on the applicable regulations in the EU and US. Enhance your skills to ensure your pharmaceutical products meet the quality requirements to ensure safe and efficient products for patients.
This training has been developed by the experts at Key2Compliance®. The films are animated and designed to enhance understanding and perception of the presented concepts and are presented by an AI-generated speaker.
The training is divided into 2 modules: a general presentation and short exam. After the successful completion of both modules, you will receive your Certificate of Completion.
Content
- Key concepts and requirements for GMP Laboratories including Raw material lab, Microbiological lab and In Process and Final Container Labs.
- Introduction to QC relevant regulations and guidelines in EU and US, including EudraLex, CFR, ICH, and Pharmacopoeias.
- Requirements and common practices when conducting analytical measurements including sampling and testing, risk-based work methods, handling of chemicals, reagents and standards, as well as purpose and handling of reference and retention samples.
- Validation of analytical methods and qualification and maintenance of instruments.
- Assuring data integrity through robust documentation and reporting practices as well as management of Out of Specification (OOS) and Out of Trend (OOT) results and CAPA management.
Course module
1. GMP for Quality Control for Pharmaceuticals
This course offers a foundational understanding of Good Manufacturing Practice (GMP) for Quality Control in pharmaceutical labs, covering key regulations in the EU and US. You'll learn about QC roles, procedures, and best practices to ensure high-quality, safe products for patients.
Trainer: Virtual character
Duration: 57 minutes (Total duration of the course: 57 minutes)
Course material
There is no additional course material for this course.
Notes
If you want to save your notes for this course, you first need to purchase it and be signed in.
Training organisation
Key2Compliance AB
Key2Compliance AB is an independent international organization providing its training and services to a variety of functions in the Life Science industry, from development to market in terms of Quality Systems and Regulatory compliance.
By helping organizations to comply with regulatory expectations, to enhance workforce knowledge and motivation and to promote a correct attitude towards quality, we believe we contribute to the supply of safe health care products - and in a wider perspective we save lives.
Trainer
Virtual character
This training is created by Key2Compliance AB and uses a digital avatar to convey the presented concepts, which enhances clarity and understanding of the content.
The course results in a diploma that shows that you have the skills required.
All prices shown exclude VAT.
Save time
Online education is faster than traditional education. We make the same courses and content accessible in just under a third of the time normally required.
The efficiency gain is due to the fact that there are no lunch breaks, no commute, no group discussions, and no breaks. However, the total time spent teaching always remains intact.
1 h - Equivalent to a half-day course
2 h - Equivalent to an all-day course
4 h - Equivalent to a 2-day course
6 h - Equivalent to a 3-day course
Please note that the duration specified does not include time for breaks or revision. Don't forget to set aside time for any workshops and time to take the tests of the course, which is required to earn a diploma.
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