Pharma-Engineering & Technical Systems - Live Online Training
Part II: Qualification & Manufacturing Technology
26-28 October 2027
Course No. 23302
Speakers
Holger Fabritz
VeriQum
Dr. Norbert Dinauer
Virtopharm
Martin Kisselbach
CSL Behring
Dr Harald Stahl
Romaco
Dr Hans-Joachim Anders
Novartis Pharma Stein
Anthony Cannon
MSD
Complete the “ECA Certified Engineer” Certification with Part II and Part I of Pharma-Engineering & Technical Systems – and get the complete picture of this comprehensive topic. Also register for Part I.
As a participant you will receive ECA’s Guide on GMP-Design of Equipment.
Target Group
This course is directed at staff in pharmaceutical engineering departments, at technicians, engineers, planners as well as plant constructors and equipment suppliers who are involved in tasks related to engineering work in a GMP environment.
Objectives
This intensive training course provides an overview of GMP requirements and their implementation in engineering and technical operations, and equips you with the knowledge needed to act as a competent contact person in a technical GMP environment. The comprehensive programme is suitable for employees of the pharmaceutical industry as well as technical service providers, plant manufacturers, and equipment suppliers. It covers manufacturing processes, project management, facility and cleanroom-related aspects, qualification, and quality assurance topics, providing practical tools for day-to-day routine tasks and specific projects.
The focus of this part is on qualification and the explanation of pharmaceutical manufacturing processes. Part 1 of the course can also be attended after completing Part 2.
Validation / Qualification
Not only GMP regulations but also inspectors consider qualified equipment and validated processes as the prerequisites for producing pharmaceutical quality. The identification of the equipment that has to be qualified is a crucial point. It is essential to define the requirements in a URS based on the associated risks, as this document forms the starting point for all subsequent qualification activities. Therefore, the course covers the full sequence of steps: URS, RA, DQ, FAT/SAT, IQ, OQ and PQ.
Manufacturing Processes
To identify GMP-critical processes, parameters, and quality attributes, it is essential to understand pharmaceutical manufacturing processes. Therefore, the course explains the basics of manufacturing oral solid and sterile dosage forms, as well as the required equipment.
Microbiology & Sterilisation
A prerequisite for establishing sterile processing conditions is the absence of microorganisms. This requires suitable facility and equipment design as well as appropriate process conditions and strict compliance with hygiene requirements. Therefore, the basics of microbiology are an essential part of this course and are also applied in the context of sterilisation and disinfection.
Programme
Programme Highlights o Part II
Qualification – all Steps from URS to PQ
Manufacturing Processes & Equipment for OSD and Sterile Dosage Forms
Fundamentals of Microbiology and Sterilisation
Usage of AI in the Pharmaceutical Industry
Validation / Qualification
Introduction / Overview
Regulatory background / objectives
Differences in EU and US
The Validation Master Plan
Practical session: IMPACT ASSESSMENT
For each process chain, it is necessary to identify systems with an impact on quality (quality impact) and to define the corresponding qualification/validation activities. In this session, we will review typical equipment lists from pharmaceutical manufacturing processes and perform a structured equipment assessment.
Risk Analysis
Objectives and practical implementation
Direct Impact, Indirect Impact, No Impact
FMEA and other Formats
Examples
User Requirements Specification (URS) and Functional Design Specification (FDS)
Guidance for preparation
Division of responsibilities between pharmaceutical manufacturer and equipment supplier
Examples
Practical Session: USER REQUIREMENT SPECIFICATION (URS) / RISK ANALYSIS
Risk analysis is a key element in facility planning and a major driver for qualification. In this session, we will define the user requirements (URS) and, based on these, learn and practise how to prepare a risk Analysis.
Design Qualification (DQ)
Description / objectives
Approaches to performing a DQ
Examples
Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
Linking the URS to the individual qualification phases
Typical test in the individual qualification phases
Fundamentals of Microbiology for Engineers
Relevant microorganisms in pharmaceutical manufacturing and their Habitats
Risks to systems and product, risk to the patient?
Microbiological controls in the manufacturing environment/cleanroom
Hygiene requirements
Detection methods and their limitations
Sterilisation Methods
Sterilisation vs. aseptic processes
Sterilisation, disinfection and sanitisation
Sterilisation methods and Equipment
Gaseous Sterilisation
Thermal and steam sterilisation/SIP
Sterile Filtration
Radiation Sterilisation
Manufacture of Solid Dosage Forms
Fundamentals of granulation and tableting
Requirements for the Equipment
Process Control
Facility concepts
Manufacture of Sterile Medicinal Products
Prerequisites for aseptic bulk manufacturing
Process sequences for the manufacture of pre-filled syringes, liquid vials and lyophilisates
User requirements for the design of a new filling line
Sterile filtration and media fills
100% inspection and packaging
Usage of AI in Pharmaceutical Manufacturing
Definitions of artificial intelligence and machine Learning
Data foundations: data quality, data integrity, and data management for AI
Current applications across QC, QA, Manufacturing, Engineering
Regulatory requirements: EU GMP Annex 1, validation
Concrete application examples from CSL Behring
Limits of AI and Outlook
Further Information
Technical Requirements
Our live online training courses 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 (per delegate, plus VAT)
ECA Members EUR 2,290 APIC Members EUR 2,390 Non-ECA Members EUR 2,490 EU GMP Inspectorates EUR 1,245 The conference fee is payable in advance upon receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Testimonials
