DIA- WHO-EDQM Quality of Active Pharmaceutical Ingredients

Venue: Hotel The Park

Location: Hyderabad, India

Event Date/Time: Sep 15, 2011 End Date/Time: Sep 17, 2011
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This conference is organized in cooperation with World Health Organization
(WHO), The European Directorate for the Quality of Medicine & Health Care
(EDQM) and Drug Information Association (DIA). The major focus of this
conference will be on the current regulatory requirements for the quality of
API, Compliance with GMP Standards from Global Regulatory Authorities
Perspective. The conference will also focus on the current issues of Pharmacopoeial
Monographs, as well as API Certifi cation and WHO Prequalification requirements.

• Regulatory requirements with relevance for quality of API Compliance of API manufacturers with current GMP Standards
• Current issues and challenges in the development of Pharmacopoeial Monograph
• API Certification and WHO Prequalification Program

Learning Objectives:
At the conclusion of this meeting, participants should be able to:
• Describe the regulatory issues of API manufacturing and compliance
• Explain the current compliance issues of API
• Discuss the requirements of the API under the WHO Prequalification Programme
• Outline the procedures for Certification of Suitability (CEP)

Target Audience:
? Government Regulators
? Regulatory Affairs Associates from Industry
? Chemistry Manufacturing and Controls
? Analytical Development Chemistry
? Formulation Development
? Technical Services, QA, QC

Event Code: