International Workshop on Regulatory Affairs and Quality Management System

International Workshop on Regulatory Affairs and Quality Management System

04 Dec 2017   To   08 Dec 2017    Hyderabad, India

• Get an insight of the fundamentals of pharmaceutical quality in PSM and international commerce (from manufacturing through to patient use)
• Recognize global regulatory harmonization laws, initiatives, and progress till now and how it affects your country
• Determine how to budget for quality assurance activities in the procurement budget - analyse the relevance of pharmaceutical reference standards and their impact on pharmaceutical prices
• Introductory experience in conducting GMP inspection of pharmaceutical manufacturers and gaining hands-on experience in observing and understanding QC
• Introductory experience in working knowledge of various instrumentation required for analytical testing of pharmaceuticals (GLP)

Professionals working with/involved in:
• National Regulatory Authorities in the country
• Registration of Products, GMP inspections, Analytical Testing and other related areas
• Public or private sector quality control laboratories
• Private sector manufacturers: Regulatory Affairs/Quality Assurance Department

• Pharmaceutical Regulation & its Importance
• GMP Inspection - in Theory & Practice
• Good Laboratory Practice (Analytical Testing)
• Pharmaceutical Product Quality (Product Quality Standards)
• National QA Plans and Manual
• Rational QA System (Risk Assessment, Risk Management & Three Tier System Approach)

Course fees: US $2000 which includes:
• 1 week face-to-face workshop in Hyderabad + 2 weeks preparatory work
• Certificate from Empower School of Health
• One-year technical assistance
• Local transportation for field visits

Does not include – International travel, airport transfers, food and accommodation

*Group Discounts Available

Registration deadline: 20th November, 2017

To apply, please fill the form or please email us at:

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