Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions 2014 is a seminar that covers topics such as:
- FDA`s enforcement strategy and what it means to your firm
- Different types of Warning Letters
- Being prepared to receive regulatory inspections
- How auditors think and their expectations
- When to take or not immediate action during an inspection
- When inspectional findings or events indicate potential regulatory actions
- How to make written procedures and training more effective
- Making better responses to FDA both during and following inspections
- How to identify effective compliance metrics
- How to increase the effectiveness and efficiency of internal audits
- The use of FDA`s Administrative Enforcement Tools
- Pain points, challenges and solutions
- Current FDA Enforcement Priorities: Application and Data Integrity Policy
- Inspectional Options based on Inspectional Violations
- Collateral Damage
- Civil and Criminal Penalties
- Why Does FDA Enforce
- Keys to Compliance Programs
- FDA`s Expectation on Replying to Inspections and Warning Letters
- FDA`s New Enforcement Culture
- Lessons Learned from the Actual Response
- How to Handle the Inspection
- Methodology and strategy behind Warning Letters, Seizures, Injunctions/Consent Decrees) and Criminal Prosecution
- How to Avoid Adverse Inspections and Warning Letters - its simple - COMPLY!
- Why Recalls are an example of an Enforcement Tool
- What the OIG does as an enforcement body with FDA and the latest trend with CIA (Corporate Integrity Agreements)
- FDA and industry trends with statistics and data regarding enforcement and inspection data
Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions 2014 is intended for:
- Individuals who come in contact with regulatory inspectors
- Managers responsible for GMP/GLP/GCP compliance and seeking a better understanding of FDA, inspections, regulatory actions and how they can improve their own firm`s operations and monitoring of their state of GMP compliance
- Compliance/Regulatory affairs professionals
- Auditors
- Senior management executives (CEO, COO, CFO, etc.)
- QA/QC professionals
- Project Managers
- Manufacturing managers, supervisors & personnel
- Regulatory Affairs Specialist
- Regulatory Affairs Management
- Compliance Officer
- Auditors
- Clinical Affairs
- Compliance Specialist
- Marketing & Sales
- Quality Assurance Management
- Legal Counsel
- Distributors/Authorized Representatives
- Operations/Manufacturing
- Engineering/Technical Services
- Consultants
