Live Online Training: Contamination Control Strategies
Im Auftrag der ECA Academy

Live Online Training: Contamination Control Strategies Im Auftrag der ECA Academy

Seminar Nr. 18385

All times mentioned are CET.

Kosten

ECA-Member: EUR 1890,--
Non ECA Member: EUR 2090,--
EU/GMP Inspectorates: EUR 1045,--
APIC Member Discount: EUR 1990,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Walid El Azab, Steris Corporation, Belgium
Werner Hofstetter,Octapharma, Austria
Arjan Langen,  GE Healthcare, The Netherlands
Carsten Moschner, Dastex, Germany
Inga Marie Schlägl, Bayer, Germany
Axel Schroeder, Concept, Germany
Robert Schwarz, FH Campus Vienna, Austria
Wolf-Dieter Wanner, Germany

Zielsetzung

In most cases the implementation of appropriate hygiene programmes and measures have been implemented as an essential part for the manufacturing of pharmaceutical products. A series of regulations address the subject of microbiological facility control but GMP requirements are mostly described in more general terms. But how can they be introduced in pharmaceutical companies in a practice-oriented way? What is state-of–the-art? How should detergents and disinfectants be used?

The overall goal of such a system is to prevent microbiological contamination of the pharmaceutical product. But even if such a system has been established, it is of utmost importance that these programmes and measures are understood and followed by all operators who carry out quality-relevant work. Therefore, regulations demand intensive training in hygiene issues.

Against the background of these requirements, this ECA education course is designed to cover all important aspects of controlling microbiological contamination. It ranges from sources of contamination to validation of cleaning and disinfection processes and training of operators. A focus will be on those problems that occur frequently in pharmaceutical production; possible solutions to these challenges will be discussed.

Hintergrund

The lack of control of microbiological contamination is an outstanding integral part of inspection findings.

Between 1995 – 2005, the potential risk of microbiological contamination was the No 2 Critical GMP Deficiency and the No 1 Major GMP Deficiency observed during inspections requested by the CHMP/CVMP of EMEA.
MHRA’s review of the deficiencies 2011/2012 issued 57 deficiencies related to personnel as well as 75 contaminations by chemical/physical and microbial causes.
A Permanent high  number of FDA warning letters with microbiological deviations or issues in cleaning and contamination control:
Fiscal Year 2016 – 23 WL
Fiscal Year 2017 -  24 WL
Fiscal Year 2018 – 16 WL
Fiscal Year 2019  - 32 WL
This actual state clearly demonstrates the importance to concern oneself with this topic in detail.

In pharmaceutical manufacture, cleaning and disinfection measures are important and decisive process steps for fulfilling the quality requirements on the medicinal product. To carry them out properly, personnel needs to be both qualified and motivated.
All national and international pharmaceutical GMP regulations - especially those on sterile manufacturing - call for cleaning and hygiene programmes in the pharmaceutical companies.

Zielgruppe

People who are involved in
  •  Microbial Monitoring
  •  Implementation of Hygiene Programmes
  •  Selection and Qualification of Disinfectants
  •  Handling of microbial Deviations
  •  Training of Operators for Monitoring

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

Provisional timetable, the actual schedule may vary depending on the situation

Day 1 - Module 1: Regulatrory Requirements and Background

09.00 – 09.15 h Welcome/Introduction

09.15 – 10.15 h
  • Basic Principles of Microbiology, Hygiene and
  • Contamination Control
  •  Microorganisms
    • Microbial growth
    • Characteristics
    • Sources
  •  Basic hygienic Actions
  •  Cleaning/disinfecting/sterilization
  •  Way of contamination
10.15 -11.15 h
Regulatory Requirements
  •  General regulatory requirements and guidelines
  •  Prevention of contamination and cross contamination
  •  Requirements for validation
  •  ISO standards
  •  Quality Risk Management
11.15 -11.30 h  Break

11.30- 12.30 h
Sources of Contamination and Preventive Measures
  •  Sources of contamination throughout the facility
  •  HVAC
  •  Water
  •  Raw materials and packaging components
  •  Personnel and clothing
12.30 – 13.00 h
Questions and Answers

13.00 – 14.00 h Break

14.00 - 15.00 h
Effective Training of Operators
  •  Regulatory requirements (EU-GMP, FDA Guidelines, experiences from inspections)
  •  Methods and tools
  •  Measurement and documentation of  training success
  •  Practical approaches
Day 1 - Module 2: Monitoring and Control Strategies

15.00 – 15.45 h
Microbiological Monitoring
 Monitoring of non-sterile processes
  •  Aseptic manufacture:
    •  developing a programme
    •  interpreting data
    •  regulatory requirements
  •  Monitoring methods, air, surface, people
  •  A complete programme for a sterile product
15.45 - 16.00 h  Break

16.00 – 16.45 h
Microbiological Control of Water Systems
  •  Water as raw material
  •  Contamination sources within the water system
  •  Technical aspects
  •  Control methods
  •  Microbiological testing of water
16.45 – 17.30 h
Trending of Environmental Monitoring Data
  •  How do you do it?
  •  What do the results really tell you?
  •  How should you react on the results?
17.30 – 18.00 h
Questions and Answers

Day 2 - Module 3: Personnel Hygiene and Implementation of a Cleaning/Disinfection Strategy

08.30 – 09.30 h
Cleaning and Disinfection of Surfaces
  •  Criteria of selection of disinfectants
  •  Rotation of antimicrobial substances considering their chemical interaction
  •  Cleaning potential of disinfectants
  •  Users acceptance
09.30 - 10.30 h
Qualification of Disinfectants
  •  Different gassing systems
  •  Guidance documents, standards and regulatory requirements
  •  Basis for qualification
  •  Case study for qualification of disinfectants
  •  Efficacy – how to control?
10.30 - 10.45 h Break

10.45 – 11.45 h
Hygiene of Personnel – Cleanroom Behaviour
  •  Contamination from personnel
  •  Classic employee deviance
  •  Gowning procedure
  •  Hand disinfection
11.45 -12.15 h
Questions and Answers

12.15 – 13.15 h Break

13.15 – 14.15
Case Study: Managing Disinfection Programmes
  •  Hygiene programme
  •  Cleanroom concept
  •  Demands on environment, equipment and personnel
  •  Cleaning and disinfection concept
14.15 – 15.00 h
Case Studies: Disinfections Issues
  •  Practical examples of microbial deviations after cleaning and disinfection activities.
  •  Root causes and pitfalls 
  •  Measures for troubleshooting in practice
  •  Preventive measures to avoid errors
15.00 – 15.15 h Break

15.15 – 16.15 h
Handling of Microbiological OOS/OOL  Results
  •  Failure investigation
  •  Following corrective actions and preventive actions
16.15 – 17.15 h
Cleanroom Garment, Requirements, Selection and Laundering
  •  Different fabrics and their characteristics like filtration capacity and wearing comfort
  •  Garment systems oriented by the cleanroom class
  •  Requirements on decontamination and laundering
  •  Outsourcing
17.15 – 18.00 h
Questions and Answers

Day 3

08.30 – 09.30
Validation of a Decontamination System for Production Equipment, Process Devices and Cleanrooms
  •  Technical requirements & Background
  •  Qualification of a fogging system
  •  Validation of a fogging process
Module 4:  Additional Challenges

09.30 – 10.30 h
Cleanroom Consumables - a so called „Cent-Product“ but with Consequences
  •  Definition of cleanroom consumable products
  •  The impact during the daily application
  •  How is that reflected in guidelines?
10.30 – 10.45 h Break

10.45 – 11.45 h
Quality Risk Management
  •  Risk Assessment:
    •  Risk Identification
    •  Risk Analysis
    •  Risk Evaluation
  •  Risk Management
11.45 – 12.45 h
Contamination Control Strategy - An Interdisciplinary and Dynamic System
  •  Formulate a CCS
  •  Implement a CCS and develop a strategic plan to  make the strategy work as intended by mapping/designing the organizational structure, procedures, control processes, distributing resources, developing the decision-making processes, etc.
  •  Evaluate the CCS efficiency to ensure process performance and product quality while improving the CCS level over time.
12.45 – 13.30  h
Questions and Answers

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