Holger Fabritz
VeriQum
Referierende
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 – and save 600 EUR for booking both Part I and Part II.
As a participant you will receive ECA’s Guide on GMP-Design of Equipment.
Zielgruppe
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.
Zielsetzung
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.
Programm
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
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)
- Description / objectives of the individual phases
- Use of the results in further qualification steps
- Documentation
- Examples
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
- Description / Objectives and Workflows
- 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
Weitere Informationen
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.
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.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Dr Robert Eicher, +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Sonja Nemec, +49 6221 84 44-24, nemec@concept-heidelberg.de
Dr Robert Eicher, +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Sonja Nemec, +49 6221 84 44-24, nemec@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 26 Oct 2027, 09:00-17:30 h
Wed, 27 Oct 2027, 09:00-17:30 h
Thu, 28 Oct 2027, 09:00-15.30 h
All times mentioned are CEST.
Wed, 27 Oct 2027, 09:00-17:30 h
Thu, 28 Oct 2027, 09:00-15.30 h
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 2290,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Teilnehmerstimmen - das sagen andere über unsere Seminare:
