CPhI Announces 'Unannounced Audits' Workshop for the Pharma Industry

MUMBAI and AHMEDABAD, July 24, 2015 /PRNewswire/ --

Indian pharmaceutical companies are on the radar of FDA's observations. The pace of ever-evolving standards havs led to decry of this industry. State of 'import alerts', export bans and warning letters (Form 483) over the last two years have unexpectedly increased. And these were issued mainly during surprise audits conducted by the global regulatory authorities. Indian Pharma accounts for the highest number warning letters issued by the USFDA at the same time it also accounts for nearly 40% imports by the US market.

     (Photo: http://photos.prnewswire.com/prnh/20150724/10127435)

CPhI, which hosts a number of successful and well respected pharmaceutical conferences, are conducting their first ever 'Unannounced Audits' workshop in Mumbai and Ahmedabad . The workshop is focused on addressing challenges faced by pharma professionals before and during a pharma audit.

Venue:

• 25-26 August 2015, Holiday Inn, Mumbai
• 27-28 August 2015, Novotel, Ahmedabad

Some of the important topics being discussed at the workshop include

• Understanding FDA: Laws, regulations, mission, organization
• Navigating and surviving an FDA inspection: Bridging cultural gaps in projects and showcasing issues that can be caused by misunderstandings of cultural differences
• Data integrity: A key focus in today's FDA audits
• A look at 483s, warning letters and consent decrees
• Quality risk management: Another key focus in today's FDA audits
• Conducting internal audits
• GMPs and FDA inspections: An update on current initiatives.

Expert trainers:

• Christopher Smith , Former USFDA
• Chinmoy Roy, FDA Consultant

The workshop will have more than 100+ delegates from companies like Aarti Industries, Alkem Laboratories, Biocan, Cipla, Daewoong Pharmaceuticals, Emcure, Enaltec Labs, Gennova Biopharmaceuticals, Hetero Labs, Hospira, Incepta Bioscience, Jamjoom Pharmaceuticals, Lupin, Merck Limited, MSN Laboratories, Par Formulations, Perrigo India, Pfizer, Sanofi, Sun Pharma, Teva API, USV and many more.

Complete Agenda: http://bit.ly/1KmfuF6

About UBM India

UBM India is India's leading live media and events company that engages people and enriches businesses. We at UBM India provide the industry with platforms that bring together buyers and sellers from around the world, through a portfolio of exhibitions, content led conferences & seminars, tech media, live events, data services and powerful media brands. UBM India hosts over 20 large scale exhibitions and 40 conferences across the country every year; thereby enabling trade across multiple industry verticals. A UBM Asia Company, UBM India has offices across Mumbai, New Delhi, Bangalore and Chennai. UBM Asia is owned by UBM plc which is listed on the London Stock Exchange. UBM Asia is the leading exhibition organiser in Asia and the biggest commercial organiser in mainland China, India and Malaysia. For further details, please visit www.ubmindia.in

For further information about the summit you can contact:
Mr. Mustafa Nalwalla
Marketing Manager
UBM India - Conferences
T: +91 (022) 6172 7067, M: +91 98209 99303, E: [email protected]