- Introduction
- Basics of GxP Training Management
- Modern Training Methods
- Training Metrics
- Continuous Improvement
Welcome to the course "GxP Training Excellence using Modern Training Methods (VR, AR and other)".
The objective of this presentation is to share key notes on GXP Training Excellence using modern training methods.
This course is mainly focused for employee training at GxP industries such as manufacturers of Active Pharma Ingradient, Finished Durg Product, API Intermediates, Medical Devcies, Biologics, Food Products. This can be used at contract laboratories, clinical laboratories and all other areas where GxP requireemnts are applicable.
This course covers the following:
Basics of GxP Training Management:
Basic types of GxP Training- knowledge based training and skill based training
GXP Training program- ADDIE(Analysis, Design, Development, Implement and Evaluate) model
Learning principles-
Brief about Pedagogy (Child Learning Model)
Overview of Andragogy (Adult Learning Model)
Adult learner characteristics vs Training design
Learning and Sensitivity Strategies
Introduction and Usage of Modern Training Delivery Methods for GXP Training
Training delivery methods
Modern training delivery methods
Video method
Interactive simulation/ gamification (Computer based) method
Virtual reality (Interactive Simulation) method
Augmented reality (Simulation) method
Mixed reality (Interactive Simulation) method
Selection of training delivery methods
Training Metrics and Continuous Improvement
Training evaluation levels
Blooms taxonomy 2001 levels of cognitions- for training Evaluation
Other Training metrics
Continuous improvement
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A seasoned professional, ASQConnex Expert, Trainer, Auditor, Data Scientist and Consultant providing consulting services to Pharmaceutical/ Medical Devices/ Food Products/ Other GxP industries. Founder & Director of SHAARKVIEW CONSULTANCY.
A Certified Manager of Quality/ Organizational Excellence (CMQ/OE), Certified Pharmaceutical GMP Professional (CPGP), Certified Quality Auditor (CQA), Certified Medical Device Auditor (CMDA), Certified Software Quality Engineer (CSQE) and Certified Six Sigma Green Belt (CSSGB) by American Society for Quality (ASQ), Regulatory Affairs Certified (RAC-Drugs and RAC- Devices) holder from Regulatory Affairs Professional Society (RAPS), Certified Project Management Professional (PMP) by Project Management Institute (PMI) and Certified ISO 13485 Internal Auditor by DQS (Deutsch Quality Systems) having over 20 years of experience in the areas of Production & Quality Assurance in GxP Industry.
Previously worked with major companies such as Abbott, Ipca, Dr. Reddy's, Mylan (Viatris), Alembic and Aurobindo.
Accomplished MS in Data Science from Eastern University, USA in 2024; M. Sc. in Chemistry from MP Bhoj (Open) University, India in 2006; and B. Sc. in Chemistry from Andhra University, India in 2002.
Purpose of Career: Learning Unknown, Helping Community & Earning Respect
Seetharam Kandarpa,
PMP, ASQ ConnEx Expert, ASQ CMQ/OE, ASQ CQA, ASQ CMDA, ASQ CSQE, ASQ CPGP, ASQ CSSGB, RAC Drugs, RAC Devices
Founder & Director- Shaarkview Consultancy (OPC) Private Limited