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Validation

course code : vad 001

course hours : 24 hours

PREREQUISITE: N/A

Course Description

Validation is an essential part of Good Manufacturing Practice (GMP) that provides a high degree of assurance that the equipment and or process will consistently perform as intended and stated in the pre-determined specifications. Validation work is mandatory and is regulated by the international organization such as FDA, EU and WHO guidelines. The course includes three main areas namely: Area (1) General Regulatory Guidance on Process Validation comprises: Validation terminology defined: key to communication - Effective Process validation based on the “Quality by Design” concept will lead to more in-process controls/continuous quality verification and the reduction of post-release testing - Cost of non-compliant process validation - Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. Area (2) Overview of new pharmaceutical facility qualification/validation covers: How to validate the following parameters as a pre-request for product validation raw materials - facility – equipment – environment. Area (3) Validation process includes: critical importance of corporate commitment to validation - Process Validation PV Policy/Program - The Validation Master Plan (VMP) Pre-Requisites: Facility/Utilities/Equipment Qualification: DQ/IQ/OQ/PQ.

Learning Outcomes

By the end of the course, the participant will be able to:

  • Value the importance and underlying principles of validation
  • Understand the new/revised concepts as stated by the FDA’s new Draft Guideline on Process Validation and its impact on how process validation activities are carried out
  • Understand the new FDA perspective of a “Process Validation Life-Cycle” that starts at the Process Design phase (Process/Product Development) and continues through Process Qualification (Confirmation) and Continued Process Verification (Monitoring and Assessment of the process effectiveness)
  • Able to set up project validation Master Plan (VMP) and process validation protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
  • Prepare the process validation approach/ program and avoid costly delays and rejections by regulatory agencies
  • Define the process validation approach/ program and avoid costly delays and rejections by regulatory agencies
  • Develop a Facility/Equipment Design Qualification protocol DQ
  • Implement a Facility/Equipment Design Qualification protocol DQ
  • Prepare and define the process validation approach/ program and avoid costly delays and rejections by regulatory agencies
  • Develop an Equipment Installation Qualification protocol IQ
  • Implement an Equipment Installation Qualification protocol IQ
  • Develop Equipment Operational Qualification Protocol OQ
  • Implement Equipment Operational Qualification Protocol OQ
  • Develop Equipment Performance Qualification Protocol
  • Implement Equipment Performance Qualification Protocol
  • Develop Process Validation Protocol
  • Implement Process Validation Protocol

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