- Global Pharma News & Resources
27-Jun-2019 - 28-Jun-2019

Effectively Addressing and Remediating FDA's Form 483 Findings, Warning Letters and Consent Decree Compliance Issues

This seminar will guide the attendee in effectively handling, addressing and remediating FDA's and other related compliance issues associated such as FDA's Form 483, Warning Letter and Consent Decree Compliance Findings. An effective handling and resolution of Compliance issues will prevent further disciplinary actions such as an FDA's Warning Letter or a formal Consent Decree which ends with a costly impact, fines and possible injunctions by the FDA. Because the impact of non-compliance and remediation of compliance issues are very costly, time consuming and impacting to a business and associated manufactured product including an increasing severity of disciplinary action by the FDA, understanding the triggers, effective preventative and corrective actions and an effective and expedient resolution of such compliance issues will assist a manufacturer of product in preventing expensive remediation of compliance issues, delays to product launch, impact on current commercially available product, overall business reputation, product recall, Fines, loss of impacted Product, loss of business licensure and/or prosecution by the FDA.