Effectively Addressing and Remediating FDA`s Form 483 Findings, Warning Letters and Consent Decree Compliance Issues 2019

Topics

• A description of what constitutes an FDA’s Form 483 Compliance Findings, Warning Letter or Consent Decree.
• The progression and severity of the various FDA compliance findings, triggers of the various progression of the compliance related disciplinary issues and criticality of each type.
• Discuss what companies are doing "Right" and "Wrong" when they have compliance related findings and letters such as FDA`s form 483 Findings, Warning Letter or Consent Decree.
• Discuss the reasons why some companies with recurrent unresolved FDA’s Form 483 findings end up with further progressive compliance issues such as a subsequent FDA’s Warning Letter and/or a Consent decree.
• Effective Steps in resolving FDA’s Form 483 Findings, Warning Letter and Consent Decree. The importance of expediting a company’s response to each type of compliance citation from by FDA.
• Discuss the entire process of Consent Decree and various scenarios and players in the process through remediation.
• Discuss several damaging effects arising from unresolved and difficult compliance related issues such as FDA’s Form 483 Compliance Findings, FDA’s Warning Letter and Consent Decree.
1. The cost and other impact associated with resolving compliance Remediation Costs.
2. The overall impact on manufactured products, regulatory filings, employees, product filing, and the overall business and its reputation.
• The most effective ways in addressing, handling and resolving or remediating compliance issues associated with FDA 483, Warning Letter and Consent Decree issues.
• Discuss several case studies of companies with progressive compliance issues that ended up in Consent Decree.

Who should Attend

Attendees from

• Quality Control Analyst and Management
• Senior Management
• Manufacturing Associates and Management
• Shipping and Distribution Personnel
• Stability Testing Department Personnel and Management
• Regulatory Affairs
• Quality Assurance Analyst and Management
• Process Design Personnel and Management
• Drug Packaging Personnel and Management