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GMP:READY - GMP for Engineers Online Course 12 D

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Maintenance and Operational Support

How do you deal with deviations and changes?
Are your systems in a qualified condition?
Do you have data integrity under control?

In this e-learning course you will learn more about preventive maintenance, the procedure for deviations, changes and CAPA and the topics of re-qualification and GMP-compliant documentation during plant operation.


Online Course

Delivery time 2-3 Workdays

Quantity Unit price netto Unit price incl. VAT
To 9 €99.00 €117.81*
From 10 €89.00 €105.91*
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How do you deal with deviations and changes?
Are your systems in a qualified condition?
Do you have data integrity under control?

In this e-learning course you will learn more about preventive maintenance, the procedure for deviations, changes and CAPA and the topics of re-qualification and GMP-compliant documentation during plant operation.
Even with a pharmaceutical manufacturing facility, it is necessary to take regular action to avoid wear and tear and to carry out necessary modifications and maintenance work to maintain the target condition. Only regularly maintained systems and equipment fulfil the intended purpose, i.e. are in a qualified condition.
A maintenance concept should contain an optimal mixture of failure elimination, preventive, condition-oriented, predictive and risk-based maintenance in order to ensure maximum availability.
Data integrity is also a central element of the pharmaceutical quality assurance system. The importance is reflected in regulatory documents of the WHO, MHRA, EMA and FDA and is summarized in this course unit.

Learning Goal: Learn about preventive maintenance, the procedure for deviations, changes and CAPA and the topics of requalification and GMP-compliant documentation during plant operation.

Processing Time: Approx. 45 min.

Personal Certificate: After successfully completing the final test
 

Content: 9 chapters, 2 integrated exercises, summary, final test

  • Chapter 1: Introduction
  • Chapter 2: Preventive Maintenance
  • Chapter 3: Calibration and Recalibration
  • Chapter 4: Requalification
  • Chapter 5: Deviations, Changes and CAPAs
  • Chapter 6: GMP Compliant Documentation
  • Chapter 7: Traceability
  • Chapter 8: Limitation of Liabilities
  • Chapter 9: Key Points at a Glance and Final Test

 

There are 4 additional courses available on this topic. Together - all 5 courses are available at a special bundle price:
GMP:READY - GMP for Engineers (Bundle 12 A-E)

 


ADVANTAGES

With GMP:READY you can train yourself and your employees in an uncomplicated, high-quality and flexible way.

 

Advantages for your company:

  • Cost savings due to reduced training times
  • Guaranteed and documented learning success
  • Personal Certificate
  • Easy to organise
  • Follow-up training
  • Validatable software
  • Complies with the obligation to provide evidence in accordance with Article 7(4) of Directive 2003/94/EC

 

Advantages for your employees:

  • Learn anytime, anywhere
  • Self-paced learning
  • Select the learning modules you need
  • Multimedia learning
  • Continuation of the course unit without data loss after interruption
  • More learning motivation through animated interaction
  • Effective knowledge transfer with hands-on examples

 

The online learning program offers full flexibility:

  • Self-paced learning
  • Access via user name/password
  • Browser based application
  • No software installation required

 

Target group:

  • Project managers
  • Technicians and engineers responsible for planning, operation or for qualification
  • Operators
  • Quality assurance

 

>>> Learn more about GMP:READY...

 

Contact us:

Annette Crawford
crawford@gmp-publishing.com
Phone: +49 7622 66686-74

Stefan Bühn
stefan.buehn@gmp-publishing.com
Phone: +49 7622 66686-871

Available downloads:

Course content of Maintenance and Operational Support


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You can easily access the e-learning tool GMP:READY - GMP for Engineers on the internet via user name/password.

Important: User name and password will be set up for the designated trainee. End-user has to be specified when placing the order!

The course is displayed on the internet via FIT² Coach. The following system requirements apply:

Browsers:

  • Microsoft Internet Explorer 10 or 11
  • Google Chrome (from version 52)
  • Mozilla Firefox (from version 47)
  • Microsoft Edge (Version 20 or higher)
  • Safari (from version 9)
  • or other HTML5-enabled browsers

 

Read here the Data Privacy Statement of our e-learning partner.


The GMP Compliance Adviser was used as the basis for these learning units. Some of the texts and examples were adopted.

Would you like to train a larger number of employees with this tool?

Please contact us to obtain more information about our services and products.
We will provide an individual quotation tailored to your specific requirements.

Annette Crawford 
crawford@gmp-publishing.com 
Phone: +49 7622 66686-74

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