Dr Ingrid Walther
Freelance Consultant and GMP Expert, Chair of the ECA Cannabis Working Group
Referierende
Markus Multhauf
Consultant Pharmaceutical Engineering
Dr Jan Rau
Dockweiler
Nikolaus Ferstl
Facility Engineering Services
Dr Jean-Denis Mallet
Former Head of the French Inspection Dpt.
Dr Markus Keller
Fraunhofer Institute for Manufacturing Engineering and Automation (IPA)
• Regulations in the Technical GMP Environment
• GMP-compliant Facility and Equipment Design
• GMP Requirements for Cleanrooms, HVAC and Clean Media Systems
• Retaining the GMP Status: Renovation, Maintenance & Calibration
All participants receive ECA’s Guide on GMP-Design of Equipment
Zielgruppe
This course is directed at staff in pharmaceutical engineering departments, technicians, engineers, planners, as well as plant constructors and equipment suppliers who are involved in tasks related to engineering work in a cGMP Environment.
Zielsetzung
Technical compliance in pharmaceutical engineering spans the full manufacturing lifecycle and goes beyond meeting GMP/FDA guidelines: it also includes expectations from filings, ISO standards and established industry good practices.
This course focuses on key compliance topics in the technical GMP environment, including technical QA systems (change control, deviations), GMP-compliant facility and equipment design (layout, cleanrooms, HVAC, materials/certificates) and qualification strategy based on risk analysis. It also addresses current lifecycle expectations such as Annex 15 and practical aspects of maintaining the qualified state in routine operation (maintenance, calibration, repairs and renovation).
This course focuses on key compliance topics in the technical GMP environment, including technical QA systems (change control, deviations), GMP-compliant facility and equipment design (layout, cleanrooms, HVAC, materials/certificates) and qualification strategy based on risk analysis. It also addresses current lifecycle expectations such as Annex 15 and practical aspects of maintaining the qualified state in routine operation (maintenance, calibration, repairs and renovation).
Programm
QA Systems with Technical Relevance
Part 1:
Change Control, Technical Changes
- Regulatory Requirements
- Identification of „Changes“ – What has to be handled under Change Control?
- CC-Workflow and pitfalls
- Change Management in Routine Operations vs. Project work
- Marketing Authorisation – Regulatory Affairs for Engineers
Part 2:
Deviations, CAPA & Malfunctions
Deviations, CAPA & Malfunctions
- Deviations in the technical Environment
- Documentation in logbook and higher-level Systems
- Evaluation of technical deviations
- When does a deviation require CAPAs?
- Handling of Alarms
- Correlation between changes, deviations, repairs and maintenance
- Examples
Risk Analysis
- Managing risks in the technical Environment
- Project risks
- Equipment risks
- Product risks
- Risk management Tools
- Examples
GMP Zone Concepts (sterile/non-sterile/highly potent)
- Basic GMP requirements for materials & pharmaceuticals handling
- Physical requirements (areas) vs Dynamic requirements (HVAC)
- Finding the correct requirements depending on the manufacturing Operation
- Defining an appropriate layout and air lock Concept
- Defining personnel & material flows
- Product vs Personnel Protection
- Product Protection concepts, types of air flows
- Avoiding Cross Contamination: the EMA idea
- The future of barrier systems (Isolator and RABS)
GMP Class Requirements (HVAC and Barrier Systems)
- Some HVAC system concepts (e.g. fresh air / recirculated air)
- Understanding the main parameters (volumes, pressure, cleanliness, etc.)
- GMP Classification and ISO standards, and their interaction
- The basics of air filtration and flushing air circulation
- Particle testing depending on the cleanroom Zone
- Microbiological monitoring in a cleanroom
- Requirements on construction of floors, ceilings and walls
- Classification, Qualification, Requalification of Cleanrooms
GMP-compliant Design, Commissioning & Qualification
- GMP-Design: it depends on risk and product characteristics
- Special cases & parts: e.g. heat exchanger, sampling valves, clean-room-screw
- Pest control during construction & maintenance
- SME, CQA & CPP: Keys for Commissioning & Qualification - Process
- What to include in an URS - & what not
- Documentation & Training in Projects: GEP vs. ALCOA++
- IT-life-cycle for GMP-Equipment
- Cleanability, turbulent flow & surfaces, biofilm
- Drawings: PID-Symbols & 3D-rule
Basic Aspects of Hygienic Design and Material Selection
- Risk-based approach for the selection of suitable materials
- Equipment-specific definition of the hygiene-critical area
- Open & closed Equipment
- Construction aspects
- Cleanability
- Drainability
- Pipe Connections
- Screw Joints
- Inner corners and angles
Process Contact Surfaces: Specifications and Surface Treatments
- Definitions of surface qualities
- Surface quality requirements
- Surface treatment methods
- Mechanical Treatment
- Chemical Methods
- Electrochemical treatment
Requirements and Components for Hygienic Tubing Systems, Welding & Weld Examination
- Piping & Tubing Standards
- Cleanability & Dead Legs
- Detachable Connections
- Welding Technology & Welding Quality Criteria
Requirements for the Process Environment: the Clean Room
- Clean Room standards and classes
- Selection and procurement – factors influencing the selection of components
- Wall and ceiling Systems
- Acceptance tests for wall and ceiling
- Requirements for clean room doors
- Floor systems
- Acceptance tests for Floors
- Critical clean room interfaces
- Application of components for different cleanliness classes
Upgrading, Re-Construction and Renovation of Facilities
- Required as built documentation to start
- What to consider in re-construction projects?
- Upgrade of an HVAC System
- How to protect the ongoing manufacturing operations
- Protection of products
- Protection of equipment, rooms and HVAC
- Flow concepts and control of external personnel
- Access control, pest control, cleaning
- Documentation of protective measures
- Examples from recent projects
GMP Utility Systems (Water / Steam / Gases)
- Generation: From Source Review to Purified Water, WFI, Pure Steam
- Components: working principles (Softener, EDI, RO, UF...)
- Storage and Distribution concepts
- Sanitisation principles
- Automation, Instrumentation, Trending
- Specification & Design for Compressed Air
- Safety for Nitrogen-Systems
- API contaminated waste water
Maintenance & Calibration
- Life-cycle model of pharmaceutical Equipment
- How to set up and maintain a maintenance/calibration system
- Definition and control: frequencies, activities, tolerances, acceptance criteria, etc.
- Timing of activities
- Documentation & labeling
- Data integrity
Weitere Informationen
Venue
Heidelberg Marriott Hotel
Vangerowstr. 16
69115 Heidelberg
Heidelberg Marriott Hotel
Vangerowstr. 16
69115 Heidelberg
+ 49 6221 908-0
info.heidelberg@marriott.com
info.heidelberg@marriott.com
Fees (per delegate plus VAT)
Non-ECA Members EUR 2,490
ECA Members EUR 2,290
APIC Members EUR 2,390
EU GMP Inspectorates EUR 1,245.-
The conference fee is payable in advance after receipt of invoice and includes conference documentation, get-together on the first day, lunch on all days and all refreshments.
VAT is reclaimable.
Non-ECA Members EUR 2,490
ECA Members EUR 2,290
APIC Members EUR 2,390
EU GMP Inspectorates EUR 1,245.-
The conference fee is payable in advance after receipt of invoice and includes conference documentation, get-together on the first day, lunch on all days and all refreshments.
VAT is reclaimable.
Get-Together
On 01 June 2027, you are cordially invited to a Get-Together. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
On 01 June 2027, you are cordially invited to a Get-Together. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG after registering for the course. Reservations should be made directly with the hotel. Early booking is recommended.
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG after registering for the course. Reservations should be made directly with the hotel. Early booking is recommended.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on-site and that there will not be any opportunity to print the presentations on-site. After the event, you will automatically receive your certificate of participation.
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on-site and that there will not be any opportunity to print the presentations on-site. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
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
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
Datum & Uhrzeiten
Tue, 1 June 2027, 09:00-17:15 h
(Registration and coffee 08:30-09:00 h)
Wed, 2 June 2027, 08:30-17:30 h
Thur, 3 June 2027, 08:30-14:45 h
(Registration and coffee 08:30-09:00 h)
Wed, 2 June 2027, 08:30-17:30 h
Thur, 3 June 2027, 08:30-14:45 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
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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