Training Services

REGULATORY RELATED TRAINING SERVICES

Certification Program

i) Internal Auditor Certification program in ISO 9001/ISO 13485
ii) Certified Risk Management Professional(RMP)program as per ISO 14971 requirements.

Awareness Training Program:

i)QSR 21 CFR Part 820 requirements
ii) ISO 13485:2003/EN ISO 13485:2012 requirements
iii)Computer System validation(21 CFR Part 11)
iv)IEC 62304 Medical Device Software Development Life Cycle(SDLC)
v) GMP
vi)GAMP

MODERN MANAGEMENT CONCEPTS RELATED TRAINING SERVICES

i)TPM Concepts, Implementation of 5”s”& KEIZEN Concepts
ii)Implementation of TQM tools
iii)Mistake proofing(POKA YOKE)
iv) DR & FMEA Concepts v) Training on Total Employee Involvement(TEI)

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