The workshop aims to provide in-depth training to organisations on devising a well thought out corrective action plan to deal with 483s
CPhI Conferences, a division of UBM India, which hosts a number of successful pharmaceutical conferences to host premier edition of ‘Response to 483s’ Workshop on August 21, 2017 at The Westin Garden City, Mumbai.
To address this ongoing industry challenge and bridge the gap between internal audits and external obligations, CPhI India is all set to launch the premier edition of the workshop on ‘Response to 483s’. Powered by unrivaled 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 Brian G Nadel, with over eleven years experience working with the US FDA, and several years’ experience in: pharma 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. The workshop aims to bring stakeholders on a single platform to understand and fully prepare for their next FDA audit.
Responding to 483s is a major challenge being faced by pharma companies of late, and a timely and effective response to 483s is of utmost significance. With the US FDA keeping a close check on observations in a pharma facility, it is imperative for organisations to be knowledgeable about the best practices in dealing with 483s.