Good Engineering Practice for Pharmaceutical Companies and Suppliers
1-3 June 2027, Heidelberg, Germany
Course No. 22969
Speakers
Dr Ingrid Walther
Freelance Consultant and GMP Expert, Chair of the ECA Cannabis Working Group
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
Target Group
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.
Objectives
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).
Programme
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 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
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.
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.
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.
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.
Conference language The official conference language will be English.
Testimonials
