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ISPE India Foundation

ISPE India Annual Conference 2024

Revised Schedule M Critical Requirements for Manufacture of Biological Products

Understanding Computer System Validation requirements as per revised Schedule M

Revised Schedule M Practical approach to implement Quality Risk Management

Qualification of Analytical Instruments Schedule M, WHO,USP and EU Requirements

P W Systems compliance to India , US , EU Pharmacopeia using QRM & PAT

Master Revised Schedule M – New Critical Requirements for Manufacture of Oral Solid Dosage Forms

Qualification and Validation principles to meet revised schedule M requirements

Understanding Revised Schedule M Part II Ensuring Compliance in Sterile Product Manufacturing

' GMP's for Modern Pharmaceutical Water

Rouging in Pharmaceutical Water System

OECD GLPs for in vitro studies

Lesson learnt on FDA citations on cleaning, disinfection and sterilization’

FDA’s Quality Management Maturity and Quality Ratings Program

Application of Artificial Intelligence AI & Machine Learning ML in pharmaceutical Industry

Revised Annex 1 GMP for sterile products

GMP Requirements for Pharmaceutical Gases and Clean Compressed Air

Determination of Metal Impurities in Pharmaceutical Products

Risk Based approach in CSV

Inspection of Injectable Products for Visible Particulates FDA Guidance

Good Practices for computerised systems in regulated ‘GxP’ environments

Smart Robotic Solutions for Pharma Applications – Opportunities and Challenges

Microbiological Quality Considerations in Non sterile Drug Manufacturing per FDA’s Guidance

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