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Presentation on ICH Guideline

Presentation on ICH Guideline

ICH Design Space Key Messages

ICH Development

ICH Inspection

ICH Introduction to the new paradigm

ICH Manufacturing Implementation

ICH Pharma Quality System Key Messages

ICH Control Strategy Key Messages

ICH Presentation on Q8 9 10

ICH Q1E Presentation

ICH Q3D Module 0 – Overview

ICH Q3D Module 1 – Developing Acceptable Levels for Other Routes of Administration

ICH Q3D Module 2 – Justification for Exceeding a PDE

ICH Q3D Module 3 – Developing Acceptable Levels for EI not in Q3D

ICH Q3D Module 4 – Considerations for Large Volume Parenterals

ICH Q3D Module 5 – Risk Assessment

ICH Q3D Module 6 – Controls on Elemental Impurities

ICH Q3D Module 7 – Calculations Options

ICH Q3D Q-IWG_Web_Basic_training

ICH Q3D Q-IWG_Web_Case_Study

ICH Q3D Q-IWG_Web_Key_Messages

ICH Report on Q IWG Activities

ICH The Case Study


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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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