Good Manufacturing Practices in 21st Century By :Ady Sadek M.Sc. , P.Chem. proGamma Science Corporation 2011 proGamma Science Corporation About Us proGamma Science Corp:…

Abstract Purpose – Information security is a growing concern in society, across businesses and government. As the offshore IT services market continues to grow providing…

Our Motto Our Motto “Start to Finish “Start to Finish Every Thing in Between”Every Thing in Between” J. RamniwasJ. Ramniwas Our Motto : “Start to Finish, every…

PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PE 009-9 (Annexes) 1 September 2009 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL…

FDA Update on Implementation of Quality by Design (QbD) The New Jersey Pharmaceutical Association For Science and Technology September 17, 2009 Richard (Rik) Lostritto, Ph.D.…

The New Quality Paradigm Introduction Drug Regulations 1 “Risk-based” concepts and principles Drug Regulations 2 Pharmaceutical Development (Q8) Changed Paradigm Past:…

PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PE 009-9 (Part I) 1 September 2009 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS…

SUPLEMEN I PEDOMAN CARA PEMBUATAN OBAT YANG BAIK 2006 FIRST SUPPLEMENT FOR GUIDELINES ON GOOD MANUFACTURING PRACTICES 2006 Badan Pengawas Obat dan Makanan RI National Agency…

Understanding the Philosophy of Quality by Design (QbD) Tom Sam Global Regulatory CMC Organon, part of Schering-Plough Corporation What is Quality? Quality Requirements =…

1. RISK MANAGEMENTTopic: Managing Quality Risk through control chartPresented By:Ritesh AgarwalSunam Pal1 2. Is Risk a symbol of danger or symbol of opportunityAnswer:…