american medical association conference and clinical research trials, GMP certificate, ISO certificate, GCP certificate
GCP
Basic Training Good Manufacturing Practices (GMP)
Basic Training Good Manufacturing Practices (GMP)
Basic Principles of GMP
Introduction to the training course
Quality management
Sanitation and hygiene
Qualification and Validation
Complaints and recalls
Contract production and analysis
Self-inspection and Quality Audits
Personnel
Premises
Equipment
Materials
Documentation
Good Practices in Production and Quality Control
Sterile production
Active Pharmaceutical Ingredient
GMP Inspection Process
Introduction
The role of the inspector
Preparation for an inspection
Types of GMP inspection
The inspection
The following documents have been used as the basis of the course material:
Quality assurance of pharmaceuticals – A compendium of guidelines and related materials Volume 1, Geneva, World Health Organization, 1997
Quality assurance of pharmaceuticals – A compendium of guidelines and related materials Volume 2: Good manufacturing practices and inspection, Geneva, World Health Organization, Updated edition, 2004
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-Ninth Report, Geneva, World Health Organization, 2005 (WHO Technical Report Series, No. 929)
Annex 2: Good Manufacturing Practices: requirements for the sampling of starting materials (amendment)
Annex 3: WHO Good Manufacturing Practices: water for pharmaceutical use
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fortieth Report, Geneva, World Health Organization, 2006 (WHO Technical Report Series, No. 937)
Annex 2: Supplementary guidelines on GMP for heating, ventilation and air-conditioning systems
Annex 3: Good manufacturing practices: supplementary guidelines on GMP for the manufacture of herbal
medicines
Annex 4: Good manufacturing practices: validation
Additional Reading Material
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-third Report, Geneva, World Health Organization, 1993 (WHO Technical Report Series, No. 834)
Annex 3: Good Manufacturing Practices for biological products
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth Report, Geneva, World Health Organization, 1996 (WHO Technical Report Series, No. 863)
Annex 7: Good Manufacturing Practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for studies (clinical trials) in humans
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-sixth Report, Geneva, World Health Organization, 2002 (WHO Technical Report Series, No. 902)
Annex 8: Quality systems requirements for national good manufacturing practices inspectorates
Our Partners:
Sheraton Hotel Montazah
1) Quality of our services confirmed by audits.
2) International level of GCP / GMP / ISO trainers and auditors.
3) You can check at any time any GCP / GMP / ISO certificate for authenticity.
06 July 2014
Current GDP Audit - contract research organization (CRO)
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