Risk-Based Approach for Commissioning, Qualification & Validation in Pharmaceutical Industries/project (ASTM 2500 and ISPE Baseline Guide for Commissioning and Qualification 2019)-

Engineering and Validation

3 days (2 days can be customized)
Course fee

Program Description

Topics to be covered with this training includes:

  • Introduction: History of Commissioning and Qualification in the Pharmaceutical industry
  •  Introduction to Qualification & Validation
  •  Introduction to Risk-Based Q&V approach
  •  Qualification & Validation and Regulatory Requirements (User Requirement Specifications “RS”, Risk Assessment “RA”, Factory Acceptance Test “FAT”, Site Acceptance Test “SAT”, Installation Qualification “IQ”, Operation Qualification “OQ”, Performance Qualification” PQ”
  •  Risk-Based Qualified equipment Management (Requalification, Change Control)
  •  Discussion FDA inspection findings and warning letters

Target Level

  • Validation and Qualification scientists, Supervisor and Manager
  • Engineering Department Staff (Maintenance, Project Management, Utilities Engineers)
  • Profession0061ls from service organizations and vendors who serve pharmaceutical clients
  • Quality Department (QA, QC, Regulatory Affairs and Compliance)
  • Regulatory bodies involved in pharmaceutical industries
  • Internal/External Auditors and consultant
  • Production Manager or supervisors


Objectives and Expected Results

  • The participant will take Idea about the new and updated godliness for development the Qualification and Validation Protocol utilizing Risk Based approach, and how can save time, cost and increase the compliance
  • Participants will understand all cGMP's trends required in handling all Qualification & Validation (Q&V) activities in both Sterile and non-Sterile pharmaceutical manufacturing Facilities.
  • Participants will understand how all Qualification & Validation (Q&V) activities will interact together within the same department or among different departments to achieve an ideal team-work spirit and integrity.
  • The trainee will understand the regulatory basics for equipment Qualification, Validation, and Engineering Requirements in the pharmaceutical industry field.
  • Participants will be familiar with Q&V related topics for European, US FDA, and other international requirements expectations and how they are reflected and implemented on the field.
  • The participant will have an idea about Equipment/System lifecycle starting from setting User Requirement Specifications (URS), handling Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification(PQ) including protocols execution, implementation, and system development, in addition, to implement  Requalification, Change Control system and finally System Retirements.
  • Participants will be able to make an evaluation for the acceptable and the best practices applied on Equipment/Systems in terms of Qualification & Validation Activities within a firm.
  • Participants will be able to maintain the qualification status for Equipment/Systems and equipment during operation.
  • The participant will harmonize the Quality System and its coherence with other departments especially Qualification/Validation activities as well as engineering ones.
Participants will be able to discuss and handle Q&V/Engineering product quality attributes impact with inspectors from both Local and International authorities.

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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