Md. Saddam Nawaz

16 Abonné

A pharmaceutical and biopharmaceutical professional with 12 years of practical expertise in the development, integration, management, and improvement of quality management systems for GMP and technical processes. Having a thorough understanding of how quality systems can govern and improve lean, efficient, and productive GMP operations. Successive increases in responsibilities and multi-disciplinary duties allow me to have a broad perspective of manufacturing capabilities, global compliance standards, and how to integrate the two within an efficient and effective Quality System.

md saddam nawaz pharmaceuticals fda ich ep bp usp method validation method development quality risk management quality by design q10 q9 q8 pharmaceutical process validation 21 cfr r&d ich q2 technology transfer pat quality management good manufacturing practice gmp linearity precision accuracy particle size distribution analyzer usp 1092 dissolution fmea fta cpp cqa life cycle drugs ema pharmaceutical development quality qualification validation continued process verification verification eu annex 15 ispe astm e2500 pharmaceutical qualification and validation equipment utility facility

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Md. Saddam Nawaz

PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS

Method Development and Validation : Laser diffraction particle size analyzer (PSD)

Dissolution procedure development and validation, USP 1092

21st Century Regulatory Step by Step Compliance Part-1

21st Century Regulatory Step by Step CompliancePart-2 Facility, Utility, Equipment, Qualification