This training is aimed at Production, QA and engineering Departments of pharmaceutical companies to maintain product quality and patient safety in a regulatory compliant and agile production life cycle. Suppliers for the pharmaceutical industry are also addressed in order to better understand the requirements of their customers.
Objectives
This GMP training aims at unveiling possible risks of cross contamination during the production process of pharmaceutical products and APIs. This is especially important for patients’ safety, product quality and to be in compliance with chapters 3 and 5 of the EU GMP regulation. The prevention of cross contamination has to be documented accordingly taking into consideration QRM principles according to ICH Q9.
Learn:
How to detect possible risks
How to avoid cross contamination
How to prove the avoidance of cross contamination
Ho to document a regulatory-compliant strategy
Programme
Regulatory Requirements: Contamination Control Strategy & Cross Contamination
The view of EMA
The view of US-FDA
Shared facilities regulations
Contamination and sterile products
Sources of Contamination – Modes of Cross Contamination – Segregation
Do different sources mean different impact?
Where cross contamination could occur and different likelihoods
The PDE/ADE concept: how much contamination is allowed?
Avoiding cross contamination
Airborne contamination
Contamination of surfaces
Containment verification
Cross-Contamination from the Perspective of a GMP Inspector
GMP inspector's expectations for avoiding cross-contamination (including organizational and technical measures)
How to decide: dedicated or shared facility?
Annex 1 and the requirements for non-product-contact surfaces
Cleaning validation and cross contamination
Cross Contamination through poor Organisation
Organisational points to consider
The human factor
The importance of training and motivation
Cross Contamination through poor HVAC Design
Airborne particles
Pressure / hygienic zones – maintaining over pressure
The clean corridor concept
Simulation and visualisation of air flow
Classification of ventilation systems
Concepts for HVAC systems
Components of AHUs (filters, Duct work, etc...)
Classification and change of filters
Control and monitoring strategies
Cross Contamination through poor Equipment Design
Cleanability of equipment as the key to avoiding crosscontamination
In-line cleanability? – Cleanability for parts that are disassembled?
Importance of drainability (cross contamination by product and detergent residues)
Gap-free and dead-space-free design of system components
Components (connections, valves, pumps, sensors)
Mixing and preparation vessels, bioreactors
Cross contamination due to lack of technical support
Deterioration of surface Quality
Wear of static and dynamic seals
Cleaning & Cleaning Validation
Poor Cleaning – main reason for cross contamination
Dealing with multipurpose strategies in cross contamination control
Cross contamination – main focus of cleaning Validation
Documentation: CCS, HBEL assessment, QRM
Cross contamination control and CCS
HBEL – from the environmental risk to patient’s risk
Cross contamination control – it is all about QRM
Further Information
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the Information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT) ECA Members EUR 1,890 APIC Members EUR 1,990 Non-ECA Members EUR 2,090 EU GMP Inspectorates EUR 1,045 The conference fee is payable in advance after 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.
Testimonials
