The Phama audit excellence training series

Time:October 03-05, 2013

Country&Region: India

Venue:Mumbai, India

Organizer:UBM India

Only for Pharmaceutical and API manufacturing companies.

483’s and Warning letters from regulatory authorities are on the rise and as the Indian pharmaceutical industry prepares itself for more stringent laws and inspections, we at CPhI want to ensure the continued sustainability of the industry. For this we have developed a unique first-time ever training course focused on helping you overcome the challenges around regulatory inspections, 483 observations and addressing warning letters received.

This two-day intensive course will cover training on :

Technical writing – to help you improve your timely response to a 483 observation
Quality Risk Management
Failure investigation – What makes a good inspection, carrying it out, Root cause analysis and CAPA

And will also have workshops covering

Latest warning letter case studies

What went wrong
What went right
Key lessons

Key do’s and don’ts

Smart best practices

Overview of key expectations from the global regulators

The Phama audit excellence training series will be made available for the following departments of pharmaceutical manufacturing companies

Quality Assurance
Qualiy Control
Regulatory affairs
Audits
Production / Manufacturing

Contact:UBM India

Tel:+91 (022) 61727001 / 022 61727272

Website:http://www.pharmaauditexcellence.com/

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