FAQs Archiv - Page 2 of 4 - QP-Engineering

Q: Do I receive a certificate after completing the training?

Yes, every participant receives a certificate of attendance upon successful completion of the training, confirming the topic, scope, and dates of the course.

Q: Can I also attend the training online?

We prefer to deliver our training in person. That said, we can also train your team online by arrangement.

Q: How is the GMP training delivered?

Our GMP training is led by experienced trainers and combines theoretical knowledge with practical examples. The courses are designed to be interactive, supporting the learning process and ensuring a genuine connection to real-world practice.

Q: What are the learning objectives of the GMP training?

Participants gain in-depth knowledge of GMP guidelines and practices. This covers the fundamental principles, current trends, and best practices in the industry. Participants also learn how to apply this knowledge effectively in their daily work.

Q: Who is the GMP training and professional development suitable for?

[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" hide_on_mobile="small-visibility,medium-visibility,large-visibility" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" border_style="solid"][fusion_builder_row][fusion_builder_column type="1_1" type="1_1" background_position="left top" border_style="solid" border_position="all" spacing="yes" background_repeat="no-repeat" margin_top="0px" margin_bottom="0px" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="no" hover_type="none" min_height="" link=""][fusion_text] Our GMP training is ideal for professionals in the pharma industry, especially for those who want to deepen or refresh their knowledge of Good Manufacturing Practice (GMP). This includes quality managers, production managers, quality engineers, and everyone working in regulated production environments. [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Q: What is the biggest challenge in GMP qualification and validation?

One of the biggest challenges is the scientifically sound preparation and presentation of the results of a GMP qualification and validation. Another challenge is the correct and GMP-compliant documentation of the tests. Extensive protocols have to be maintained to trace the steps and outcomes of the processes. On top of that, compliance with regulatory requirements is critical — and these requirements can vary from country to country and change over time. QP-Engineering carries out the GMP-compliant qualification and validation carefully on your behalf, so you can focus on the success of your business.

Q: Why is GMP qualification and validation important for my company?

GMP qualification and validation is essential in regulated industries to ensure the safety and efficacy of products and to meet regulatory requirements. It also strengthens trust among consumers and across the industry. Qualification and validation are an integral part of the quality management system in these industries, and they help your company operate successfully, safely, and sustainably.

Q: What is PQ validation?

Performance Qualification (PQ) is documented evidence that all production processes meet GMP requirements in operating conditions. PQ validation is based on predefined acceptance criteria that specify which quality parameters must be met for the process to be considered validated. These criteria are normally documented in the validation plans and protocols.

Q: Was ist die größte Schwierigkeit bei der GMP-Planung?

Die Komplexität und stetige Aktualisierung der GMP-Richtlinien erfordern eine umfangreiche und vor allem detaillierte Dokumentation der GMP-Planung. Unternehmen müssen zudem ständig in Schulungen und Qualifikationen für Mitarbeiter investieren und sicherstellen, dass diese die Richtlinien genau umsetzen. Darüber hinaus erfordert die Implementierung von GMP eine tiefgreifende organisatorische und kulturelle Anpassung, wobei die fortwährende Überwachung und Durchsetzung der GMP-Standards zusätzliche Ressourcen bindet. QP-Engineering unterstützt Sie bei diesem Prozess, damit Sie sich auf Ihr Unternehmen konzentrieren können.

Q: Who needs GMP qualification and validation?

GMP cleanrooms, facilities, and equipment must be qualified, while GMP-compliant processes must be validated. Documented qualification and validation are typically carried out using the V-Model. This is particularly important for suppliers — any company that wants to supply pharmaceutical customers needs to have its production qualified for GMP manufacturing, along with the products themselves.