Slide 1 Good Documentation Practice The 1972 Devonport, UK, incident resulted in at least five deaths when drug products designed to be sterile became contaminated and recipients…

WHO Technical Specifications and Pre-Qualification UNICEF Vaccine Pre-Tender 2010-2012 Copenhagen Denmark 10 December 2008 Dr. Nora Dellepiane, Scientist WHO/IVB/QSS Carmen…

1. Qualify Facilities, HVAC andWater SystemsJerry LanesePh.D.The Lanese Group, Inc. 1 2. Credits : GAMAL AMER, PH. D. PRINCIPALPREMIER COMPLIANCE SERVICES, INC.2 3. Critical…

1. DOCUMENTATIONPresented By- Shivani Gupta M.Pharm (pharmacology)1 Sem I.P.S. College of pharmacy 2. OBJECTIVEThe objective of this presentation to emphasis the importance…

1. Doc. 080 issue 00CDG Certification• ISO 9001:2008Quality Without Complexity• ISO 14001;2004• ISO 22000:2005• ISO 13485:2003• OHSAS 18001:2007• CE MARKING CDG…

DESIGN QUALIFICATION DESIGN QUALIFICATION 1 Facilitator:- Dr. Gangadhrappa, Asst professor, Dept of pharmaceutics, JSSCP, Mysuru. Submitted by:- Ram Mohan S.R. 1st M pharm…

Slide 1 Top Tactics for Maximizing GMP Compliance in Blue Mountain RAM Jake Jacanin, Regional Sales Manager September 18, 2013 Slide 2 Presentation Objectives  Convey…

Slide 1 Quality Control Testing in Procurement Helene Möller, M.Pharm, PhD Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme…

Slide 1 1 International API Inspection Pilot Program Olivier Gross Scientific Administrator EMEA DIA International Conference Quality of Active Pharmaceutical Ingredients…

Slide 1 Slide 2 1 Auditing for Compliance It is important to periodically do self-inspections to assure that your policies, practices, procedures, etc. meet the minimum cGMP…