Preparation Phase of GMP Equipment Management

Preparation Phase of GMP Equipment Management

Version 1.0

Released on 12/11/2024

Learn essential steps in GMP equipment qualification, including documentation, stakeholder coordination, and risk mitigation, to ensure compliance and efficiency in pharmaceutical operations.

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Preparation Phase of GMP Equipment Management

Version 1.0

Released on 12/11/2024

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Pharmuni certificate
Preparation Phase of GMP Equipment Management

Released on 12/11/2024

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  • + Certificate
  • Available on app
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  • Shareable certificate of completion

About the Preparation Phase of GMP Equipment Management

Preparing for GMP Equipment Qualification is designed to guide professionals in the pharmaceutical industry through essential steps in GMP equipment qualification. This course covers critical preparatory actions, such as collecting and organizing required documentation, ensuring equipment readiness, managing stakeholder coordination, and implementing risk mitigation strategies. By aligning with regulatory standards like EU GMP and FDA guidelines, learners will gain insights into developing compliant qualification plans and maintaining version control for documents. The course emphasizes best practices for both new and existing equipment, offering strategies for thorough pre-qualification checks and compliance success. Participants will leave equipped with practical knowledge to support efficient, compliant equipment qualification processes and meet industry standards.

TUV Certificate

ISO 9001

Quality Management System
Certificate Registration No.: 12 100 60610 TMS
Completion with

Pharmuni Certificate

Certificates issued by

Zamann Pharma Support GmbH

a TÜV-certified company in

Personnel qualification in the field of pharmacy, medical technology and quality assurance.

Consulting service in the field of pharmacy, medical technology and quality assurance.

Your Learning Objectives

This course has been desgined with learning objectives at the heart of it, so you can be assured to walk away with a valuable new knowledge set. After completing this course, you will be able to:

  • Learning Objective 1

    Identify key documentation required for the preparation phase of equipment qualification, such as user manuals, SOPs, and regulatory guidelines.

  • Learning Objective 2

    Describe the process of equipment registration, including assigning unique IDs and maintaining accurate records for tracking equipment.

  • Learning Objective 3

    Determine the key stakeholders involved in the qualification process and describe their roles in ensuring successful preparation and coordination.

  • Learning Objective 4

    Outline basic risk management strategies for minimizing potential delays during the qualification process.

  • Learning Objective 5

    Identify critical pre-qualification checks, such as verifying equipment readiness and securing equipment with locking mechanisms to prevent unauthorized use.

Benefits of this Course

Get valuable resources, and ISO backed certification through our assessment of your knowledge and access global jobs only for Pharmuni alumni.

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