Quality Risk Management (QRM) in Pharmaceutical Industry

Engineering and Validation
Laboratory
Operations
Quality
rd
Soft skills
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  1. Program Description
  2. Target Level
  3. Description
  4. Objectives and Expected Results
  5. Others Training Materials
  6. Target group
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Duration
3 days (2 days can be customized)
Course fee
-

Program Description

Topics to be covered in this training includes:

  • Part#1: Introduction (Regulatory requirements (QRM as an integral part of the quality system)
  • Part#2:  Quality risk management process:

Risk assessment (Risk identification, analysis, and evaluation)

Risk control

Risk communication

Risk review

Risk management tools for the pharmaceutical industry

  • Part#3: GMP Case Study

Target Level

  • Validation and Qualification scientists, Supervisor and Manager
  • Production Department
  • Engineering Department Staff (Maintenance, Project Management)
  • Quality Department (QA, QC, Regulatory and Compliance)
  • Regulatory bodies involved in pharmaceutical industries.

Description

Objectives and Expected Results

  • Participants will understand what concept of Risk Management In Pharmaceutical Industry is
  • Participants will understand how Risk Management can be applied within each field
  • Participants will have knowledge of how to build the Risk Assessment Team within the firm
  • Participants will take the idea of how Risk Assessment can lower the cost, save time and increase the compliance
  • The participant will take Idea about Risk Assessment in Qualification and Validation

Others Training Materials

  • Workshop, Sheets and case studies paper will be conducted and implemented during training
  • Documentary Videos will be presented.

Target group

  • -

    Trainer Languages English/Arabic

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
[email protected]
00962 798756232