- 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
Target Group
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
Objectives
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.
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
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.
Further Information
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.
Testimonials
