Current Trends in FDA Inspections

Why Should You Attend:

For a quality and compliance system to be successful, it is essential to understand the current trends in FDA inspections to ensure that your organization’s execution and monitoring of the critical quality systems will meet regulatory challenges. This is done through a number of activities, which can include monitoring changes in FDA programs, guidelines, and regulatory initiatives. An example of an important change is the recent Food and Drug Agency Safety and Innovation Act (FDASIA), which granted the FDA with new enforcement tools.

Also, it is important to monitor the latest regulatory actions taken by the Agency to understand what is important to monitor in your quality systems. This can be done through the monitoring of warning letter, FDA 483s, and other regulatory actions to establish benchmarks to measure your inspection readiness.

This webinar will focus on inspectional trends, applicable guidelines, and regulatory actions and examples of systems that can be implemented to ensure continuous compliance.

Areas Covered in the Webinar:

• FDA Inspectional Programs
• FDA Use of Quality Systems in Inspections
• FDA Inspectional Priorities
• Foreign Inspections
• FDA Enforcement Tools
• FDASIA Regulatory Impact
• Annual Trends in FDA 483 Observations
• Warning Letter Examples.
• How to Prepare for An FDA Inspection

Who Will Benefit:

• Pharmaceutical Professionals
• Top and Middle Management
• Compliance Management
• Regulatory Affairs Personnel
• API and Excipient Providers
• Manufacturing Professionals
• Service Providers
• Laboratory Professionals
• Research and Development Personnel
• Quality Professionals

Michael Ferrante
President, Quality and Compliance Associates LLC

Mr. Ferrante is President of Quality and Compliance Associates LLC and has over 40 years experience in the pharmaceutical and biotechnology fields. This experience encompasses quality systems, laboratories, R&D, clinical QA, validation, manufacturing/operations, regulatory affairs, and facilities covering all dosage forms.

During his career, Mr. Ferrante has successfully dealt with over 100 inspections by regulatory agencies, resolved warning letters, prepared and controlled compliance plans at both a site and corporate level. These interactions have occurred both domestically (US) and internationally, since he has dealt in global operations in countries such as Australia, Canada, the Netherlands, Sweden, Brazil, UK, Ireland, Germany, France, Switzerland, Italy, the Czech Republic, India, China, Malaysia, and Thailand.

He has held middle to senior management positions in startup to Fortune 100 companies up to the level of VP of Quality Systems and Compliance. Mr. Ferrante has been asked to give presentations on a number of regulatory and quality topics by the American Society for Quality, the Parenteral Drug Association, International Society of Pharmaceutical Engineers, and the Institute for Validation Technology. He has published articles in the Journal of Validation and Journal of Compliance.

Topic Background:

In the pharmaceutical industry there is always a concern about FDA inspections and how they will impact your organization. As a result all diligent companies, guided by their quality group, will prepare for inspections through a continuous review of their quality systems and the use of quality tools such as internal audits to ensure they have successful inspections. However, to have an effective system for preparing for FDA inspections, it is important to learn about the direction and emphasis that FDA inspections are taking through the monitoring of new FDA initiatives and current compliance actions taken by the Agency.

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