Dr Hans-Joachim Anders
Novartis Pharma Stein
Referierende
Arjan Langen
MSD
Axel Schroeder
Concept Heidelberg
Dr. Stefanie Bayer
Labor LS
Highlights
- Acquire a Basic Knowledge in Microbiology
- Develop an Understanding for the Meaning of Microbiology for the Quality of Medicinal Products
- Get familiar with typical microbiological Tests in the Pharmaceutical Industry
- Learn to interpret microbiological Data correctly
- Case studies on Deviations and Trouble Shooting
- Develop an Understanding for the Meaning of Microbiology for the Quality of Medicinal Products
- Get familiar with typical microbiological Tests in the Pharmaceutical Industry
- Learn to interpret microbiological Data correctly
- Case studies on Deviations and Trouble Shooting
Zielgruppe
This course is aimed at anyone who is
- looking for an initial overview of pharmaceutical microbiology
- a key member of staff in production, quality assurance, regulatory affairs or engineering who needs to make decisions, approve products and take action based on microbiological data
- a representative of a regulatory authority or an auditor who requires a basic understanding of microbiological QA and QC
Zielsetzung
Microbiological safety and control are crucial for ensuring the quality and efficacy of medicinal products. A solid understanding of microbiological principles is therefore essential not only for dedicated microbiology experts, but also for many other roles within a pharmaceutical company.
This includes, among others, the Qualified Person (QP) involved in product release, the heads of Quality Control (QC) and Quality Assurance (QA) when evaluating test results, personnel responsible in production, the HVAC engineer responsible for the maintenance of ventilation and filtration systems, and the purchaser in charge of sourcing laboratory materials, culture media, disinfectants, and related supplies.
It is the aim of this course to familiarise responsible personnel from production, quality assurance and engineering with microbiological questions. The participants learn how to interpret microbiological data and which consequences these have for the production.
This includes, among others, the Qualified Person (QP) involved in product release, the heads of Quality Control (QC) and Quality Assurance (QA) when evaluating test results, personnel responsible in production, the HVAC engineer responsible for the maintenance of ventilation and filtration systems, and the purchaser in charge of sourcing laboratory materials, culture media, disinfectants, and related supplies.
It is the aim of this course to familiarise responsible personnel from production, quality assurance and engineering with microbiological questions. The participants learn how to interpret microbiological data and which consequences these have for the production.
Programm
The Characteristics of Microorganisms
- Fungi
- Bacteria
- Mycoplasma
- Viruses
- Cellular organisation, function
- Products, toxins, endotoxins, antibiotics, enzymes
Microbial Growth
- How it occurs
- What is required for growth?
- Growth kinetics – laboratory culture versus nature
- Effect of stress factors on growth
Microbial Identification Techniques
- What is the significance of a name?
- Distribution of microorganisms in nature, raw materials and water
- Distribution of microorganisms in pharmaceutical facilities
Detection Methods and their Limitations
- What can be detected by:
- The sterility test
- The bioburden test in its various forms
- Membrane filtration, pour plate, spread plate, MPN
- The test for specified organisms
- The endotoxin test - Limits of detection and factors effecting limits of detection
Microbiological Methods: Suitability Test vs. Method Validation
The difference between a Method Suitability Test (MST) and a Method Validation will be explained using selected examples:
- The practical realization of a MST of a Microbial Enumeration Test (Ph.Eu. 2.6.12 / USP <61>) and a Sterility Test (Ph.Eu. 2.6.1/ USP <71>) is presented
- The Method Validation of a Rapid Sterility Test according to Ph.Eu. 5.1.6 / TR33 / USP <1223> is shown
Cleaning, Sanitation, Disinfection
- Why cleaning before disinfection?
- The difference between cleaning and disinfection
- Disinfectants and their efficacy
- Methods of disinfection
- Disinfection validation
Environmental Monitoring
- Sampling techniques
- Air sampling
- Surfaces
- Settle plates - Technical limitations and interpretation of results
- Is there a relationship between high results and contaminated product?
Case Studies on Monitoring and Hygienic Deviations
Pharmaceutical Water - Microbiological Control and Deviation Management
- Regulatory requirements
- Warning and action Limits
- Measures to be taken when warning and action Limits are exceeded
- Repeated non-conforming results
- Examples of warning and action limit exceedance
- Source of microbial contamination, biofilms
Sterilisation Methods
- Principles and kinetics of sterilisation
- Selection of sterilisation method
- Types of sterilisation methods
- Validation of the sterilisation process
How to Handle Microbiological OOS Results
- Typical Out-Of-Specification results
- Sterility testing | Bioburden | Endotoxin testing
- Cleanroom monitoring - Investigation of causal Connection
- Laboratory failure investigations
- Sampling/process/production failure Investigation
- Type of microorganisms
- Deviations/incidents/assessment
- Deviation/investigation report - Retesting/Reanalysis/Resampling
- Definitions
- Calculation of mean values
- Rejection/Release
Trouble Shooting - Examples and Case Studies Sessions
The aim of these special sessions is to provide participants with practical experience of the basics of microbiological deviations and trouble shootings and the difficulties associated with evaluation. On the basis of real cases, sources of contamination, possibilities of root cause analysis and the determination of corrective and preventive measures are shown.
The aim of these special sessions is to provide participants with practical experience of the basics of microbiological deviations and trouble shootings and the difficulties associated with evaluation. On the basis of real cases, sources of contamination, possibilities of root cause analysis and the determination of corrective and preventive measures are shown.
Weitere Informationen
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona, Spain
Phone +34 (93) 503 53 00
sants@barcelo.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
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 fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days, and all refreshments. VAT is reclaimable.
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.
Get-Together
On the evening of the first course day, you are cordially invited to a Get-Together including dinner. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Contacts
Questions regarding content:
Mr Axel Schroeder, +49 6221 84 44-10, schroeder@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald, +49 6221 84 44-51, strohwald@concept-heidelberg.de
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona, Spain
Phone +34 (93) 503 53 00
sants@barcelo.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
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 fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days, and all refreshments. VAT is reclaimable.
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.
Get-Together
On the evening of the first course day, you are cordially invited to a Get-Together including dinner. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Contacts
Questions regarding content:
Mr Axel Schroeder, +49 6221 84 44-10, schroeder@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald, +49 6221 84 44-51, strohwald@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 03 June 2027, 09:00 - 18:00 h
(Registration and coffee 08:30 - 09:00 h)
Thu, 04 June 2027, 08:30 - 16:00 h
(Registration and coffee 08:30 - 09:00 h)
Thu, 04 June 2027, 08:30 - 16:00 h
All times mentioned are CEST
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
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 Microbiological Laboratory Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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