Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners
FDFPH4005A Mapping and Delivery Guide
Participate in validation processes
Version 1.0
Issue Date: May 2024
Qualification | - |
Unit of Competency | FDFPH4005A - Participate in validation processes |
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Description | The unit is targets content outlined in Annex 15 of the Australian Code of Good Manufacturing Practice for Medicinal Products and should be read in conjunction with this document. It covers the skills and knowledge required to participate in validation processes. | ||
Employability Skills | This unit contains employability skills. | ||
Learning Outcomes and Application | This unit provides an overview of validation processes used to support Good Manufacturing Practice (GMP) in the pharmaceutical sector.The unit covers the skills and knowledge required by production/packaging line managers or supervisors to participate in validation processes. This person would not typically have responsibility for validation but would require an understanding of the purpose, procedures and responsibilities for different types of validation.This unit applies to people working in a supervisory or line management role. Their involvement in validation would typically be as part of a multi-disciplinary team. | ||
Duration and Setting | X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting. |
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Prerequisites/co-requisites | |||
Competency Field |
Development and validation strategy and guide for assessors and learners | Student Learning Resources | Handouts Activities |
Slides PPT |
Assessment 1 | Assessment 2 | Assessment 3 | Assessment 4 | |
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Elements of Competency | Performance Criteria | |||||||
Element: Participate in qualification processes for new or modified facilities, systems or equipment |
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Element: Participate in validation processes for new or modified facilities, systems or equipment |
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