A workshop to address the serious challenges incurred by the issuance of 483s
Mumbai, 28th July 2017: CPhI Conferences, a division of UBM India, which hosts a number of successful pharmaceutical conferences announced the premier edition of ‘Response to 483s’ Workshop scheduled on 21st August 2017 at The Westin Garden City, Mumbai.
The importance of compliance cannot be undermined in preventing unethical conduct and violations of the law. Many a times, failure to comply can lead to issuance of Form 483 and warning letters, which have an impact on reputation, new drug approvals, competitor response, loss of business and requires immense management intervention. By devising a well thought out corrective action plan, companies can mitigate the risk of further regulatory action.
Responding to 483s is a major challenge being faced by pharmaceutical companies of late, and a timely and effective response to 483s is of utmost significance. With the USFDA keeping a close check on observations in a pharmaceutical facility, it is imperative for organisations to be knowledgeable about the best practices in dealing with 483s.
To address this ongoing industry challenge and bridge the gap between internal audits and external obligations, CPhI India is all set to launches the premier edition of the workshop on ‘Response to 483s’. Powered by unrivalled content, the workshop aims to provide an in-depth training on responding to 483s through rigorous training modules and a comprehensive simulation activity.
In its first year, the workshop will feature Mr. Brian G. Nadel, with over eleven years experience working with the USFDA, and a total of over twenty-five years diverse experience in: Pharmaceutical Quality Assurance and Quality Systems; Writing responses to FDA-483 observations and FDA Warning Letters, FDA Pre-Approval and Inspection Readiness Inspections; and International CGMP Auditing for finished drug products, Active Pharmaceutical Ingredients, Fermentation, Process Validation and botanical extraction. Mr. Nadel is recognized as a leading figure among his peers and has spoken at many industry conferences in the U.S. and India.
The workshop promises to bring stakeholders on a single platform to understand and fully prepare for their next FDA audit.
Key topics of the workshop include,
- Recent trends and Review of 483s,
- Devising a CAPA for your 483,
- Continuity and commitment after writing a thorough response
- Simulation activity on how to effectively respond to a 483
About UBM India:
UBM India is India’s leading exhibition organizer that provides the industry with platforms that bring together buyers and sellers from around the world, through a portfolio of exhibitions, content led conferences & seminars. UBM India hosts over 25 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 organizer in Asia and the biggest commercial organizer in mainland China, India and Malaysia.
For further details, please visit www.ubmindia.in.
About UBM plc:
UBM plc is the largest pure-play B2B Events organiser in the world. In an increasingly digital world, the value of connecting on a meaningful, human level has never been more important. At UBM, our deep knowledge and passion for the industry sectors we serve allow us to create valuable experiences where people can succeed. At our events people build relationships, close deals and grow their businesses. Our 3,750+ people, based in more than 20 countries, serve more than 50 different sectors – from fashion to pharmaceutical ingredients. These global networks, skilled, passionate people and market-leading events provide exciting opportunities for business people to achieve their ambitions.
For more information, go to www.ubm.com; for UBM corporate news, follow us on Twitter at @UBM, UBM Plc LinkedIn
Roshni Mitra / Mili Lalwani
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