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Masteclass Training

Pharmaceutical Microbiology in Production Facilities

Meet your prominent trainer

  • Frank Mertens
  • Laboratory Consultant
  • Germany
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154771507746239302

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Course Description

Microbial purity is an important parameter for pharmaceuticals, and not only for those that are deemed to be sterile. The risk of introduction and proliferation of microorganisms needs to be managed at all steps of the production process. This is done by appropriate hygiene measures to avoid contamination of the product during manufacturing as well as by testing for microbes at different production steps. A sound understanding of regulations, specific risks and the test methods are needed to smoothly integrate the microbiological topics into the site-specific contamination control strategy.

Key Topics

Validation of aseptic processes

Microbial limit & environment testing

Regulations for sterile manufacturing

Microbiological testing and lab operations

Bacterial endotoxin test

Preservative efficacy test

Identification of micro-organisms

The sterility test and parametric release

Key Takeaways

Gain

a solid understanding of the role of microbiology in the production process

Learn

to recognize and deal with microbiological risks and issues

Understand

the science and principles behind microbiological aspects in manufacturing and lab testing

Improve

integration of microbiology in site-specific contamination control strategy

Manage

and evaluate the data of microbiological test results

Training Features

Individual case by case consultancy with the trainer

Comprehensive printed and digital course documentation

Networking with industry experts

Case studies from the trainer's experience

Certification of Completion issued by the Trainer

REGISTRATION

Delegate Fee

from 2396 € Buy

CUSTOMIZE THIS TRAINING TO YOUR COMPANY NEEDS

Based on your requirements, we will build a practical training including content tailored to your specific needs, our cutting edge methodologies and relevant modules from our training portfolio.

Request in-house training

Learn | Plan | Implement | Consult

 

88-512

Core Training course

The know how from the experts

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Action Plan building Session

Effective step-by-step + Q&A

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4-week Implementation Phase

a: Breaking into smaller tasks and getting started

b: Deployment: "Small steps for a professional, a big step for a company"

c: Analyzing early development and identifying first challenges

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LIVE: Online consulting session

Brind your individual challenges to the table and follow up on your implementation progress

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