Seetharam Kandarpa ASQ CMQ/OE, CPGP, CQA

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 Over 15 years of versatile, industrial experience in various functions like Corporate QA/ Site QA/ Global Quality Management / Production for API and Formulation facilities (approved by various regulatory agencies USFDA, TGA, MHRA, WHO etc.) of top pharma companies in India.  Wide experience in complying various cGMP regulations/ standards such as 21 CFR, ICH, WHO guidelines, EMA regulations, PIC/S, EU-GMP, Canada GMP, TGA GMP, ISO 9001, ISO14001, ISO 19011 etc.  Well versed in design of various types of quality management system documentation such as quality manual, SOPs, work instructions, site master file, corporate guidance documents, employee training program, vendor management

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About

Seetharam Kandarpa ASQ CMQ/OE, CPGP, CQA

Presentations

ICH Q10 Pharmaceutical Quaity System

How to conduct an effective internal quality audit?

ICH Q9 Quality Risk Management

Overview of ASQ Certified Quality Auditor (CQA)

Overview of ASQ Certified Pharmaceutical GMP Professional (CPGP)

ASQ CQA Part 1: Auditing Fundamentals

Overview of ISO 19011:2018 Guidelines for Auditing Management Systems

Likes

Professional Development: A Gap Between Bench 2 Bedside

Educating the Next Generation Pharmacist for Industry. The Panjab University Pharmaceutical Science Oration 2014

A platform for assurance & efficiency - Ajaz at USP PCM Mumbai 2017

ISO 9001 2015 Overview presentation

US FDA Process Validation Stage 2 : No. Of Batches Required for Process Performance Qualification.