Effectively Addressing and Remediating FDA`s Form 483 Findings, Warning Letters and Consent Decree Compliance Issues 2019 is a seminar that covers topics such as:
- 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.
- The cost and other impact associated with resolving compliance Remediation Costs.
- 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.
Effectively Addressing and Remediating FDA`s Form 483 Findings, Warning Letters and Consent Decree Compliance Issues 2019 is intended for 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
