MTP – Modular Plants, Seamless Compliance - Live Online Training
How the MTP standard is revolutionising smart manufacturing and data integrity in the GxP environment
16 June 2026
Course No. 22923
Speakers
Thomas Makait
MTP4Pharma®
Target Group
Pharmacists / Qualified Persons (QPs)
Technical Compliance Responsible
Computerised Systems Validation Responsible
Equipment Qualification Responsible
Commissioning & Qualification (C&Q) Responsible
Persons responsible for validating manufacturing processes
Suppliers (automation systems, Process Orchestration Layer (POL), Process Equipment Assemblies (PEAs)
(Engineering) service providers in the above-mentioned areas
Objectives
You will learn
a risk-based approach to ensuring compliance in the procurement process for pre-qualified Plug & Produce equipment in a pragmatic way, whilst conserving resources;
how to integrate pre-qualified Plug & Produce equipment into modular systems in a regulatory-compliant manner: physically, functionally and organisationally;
how to efficiently demonstrate the qualified status of the overall (modular) system;
how to identify the relevant stakeholders and critical issues, and derive essential training topics and measures.
be aware of the relevant topics that you should implement step by step to ensure the regulatory compliant implementation of Quality & Compliance by Design (Q&CbD) for Plug & Produce in GxP-regulated smart manufacturing facilities.
Programme
Modular Plants in the GxP Environment
Introduction and rationale
Why modularisation now?
Benefits of modularisation
Why base it on the MTP standard?
Benefits & challenges
Key concepts
Understanding products and processes
Key components of modular plants
Extending Established CSV and C&QV Practices for Modular Plants
Differences between conventional plants, modular plants and modular plants based on the MTP standard
Developing and qualifying suppliers so that they are capable of supplying pre-qualified equipment
Maximising the benefits of modular plants from a QA/CSV/C&Q perspective.
Supplement the Validation Master Plan (VMP) and Qualification Master Plan (QMP) for modular plants to
Minimise data integrity risks
Increase CSV efficiency => integrated approach to validating computerised systems, including equipment qualification
Establish flexible change/deviation management
CSV Validation Plans including Equipment Qualification
For the (entire) modular plant system
For the key components of modular plants
Control level: Process Orchestration Layer (POL)
Automated equipment: Process Equipment Assemblies (PEAs)
Flexible integration of pre-qualified (mobile) PEAs
Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
FAT plan / protocol for pre-qualified automated modules
SAT plan / protocol for pre-qualified automated modules
Initial and recurring for mobile modules
Qualification of the modular plant system comprising POL and pre-qualified modules (PEAs), up to and including the completion of the Site Acceptance Test (SAT) and handover to the manufacturing process validation
Further Information
Technical Requirements Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees Non-ECA Members 690 EUR ECA Members 590 EUR APIC Members 690 EUR EU GMP Inspectorates 490 EUR The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
You cannot attend the Live Event? Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
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