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Life Sciences GMP: Deviation Investigation and Regulatory Requirements

NQR Code:NM-5-LS-04436-2025-V2-LSSSDC

  • Old Code: NM-5-LS-04436-2025-V2-LSSSDC

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About this Qualification

Job Description

The Deviation Investigation and Regulatory Requirements Program equips life sciences professionals with foundational knowledge and practical skills in auditing within the life sciences sector, focusing on common audit failures, differences between CDSCO, FDA and European audits, and essential auditor qualifications. Participants will learn to conduct root cause analyses, compare regulatory audit styles, and align auditor competencies with GMP and ISO 19011 standards through practical activities and personal development planning.

Eligibility Criteria

Criteria 1 Criteria 2 Experience Training Qualification
Completed 2nd year of 3-year/ 4-years UG In relevant field No Experience None
Pursuing 2nd year of 3-year/ 4-years UG In relevant field No Experience None
Pursuing 2nd Year of 2 year diploma after 12th In relevant field No Experience None

Progression Pathway

  • Not Available

Learning Module In Job Role/Qualifcation

National Occupation Standards (NOS)/Module NOS Code Mandatory/ Optional Estimated size (Hours) Nos Credit Level
Life Sciences GMP: Deviation Investigation and Regulatory Requirements LFS/MCr-0024 Mandatory 7.5 0.25 5