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

Instructor Profile:

Michael Ferrante, possesses a unique background in the field of pharmaceutical and biotechnology quality and compliance. He has held middle and senior management positions with companies such as Mayne Pharma, Schering-Plough, Glaxo Wellcome, Burroughs Wellcome, and Organon, Currently, Mr. Ferrante is President of Quality and Compliance Associates LLC, which provides consulting expertise to the pharmaceutical and healthcare industries regarding quality systems, regulatory compliance, FDA Interactions, and organizational evaluations and improvements.

His over 30 years’ experience encompasses both the traditional pharmaceutical industries as well as biotechnologies. This experience encompasses quality systems, pharmacovigilance, auditing, supplier qualification, R&D, clinical QA, validation, manufacturing/operations, regulatory affairs, facilities, and regulatory interactions.

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 and internationally, since he has dealt in global operations in countries such as Australia, the Netherlands, Sweden, Brazil, UK, Ireland, Germany, France, Switzerland, Italy, the Czech Republic, India, China, Malaysia, and Thailand.

He has peer recognition for his accomplishments through leadership positions he has held in the Food, Drug, and Cosmetic Section of the American Society for Quality, as a former member of the ISO committee for Cleanroom Standards, and having served on the Editorial Board of the Journal of Validation. He 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 a number of articles and was awarded Article of the Year by the Journal of Validation for his paper on “A Simple Way of Establishing Acceptance Criteria”.

Mr. Ferrante holds a BA in Chemistry from Rutgers University, a MS in Chemistry from Fairleigh Dickinson University, and a MBA in Pharmaceutical Marketing from Fairleigh Dickinson University. He also holds certification from the American Society for Quality as a Quality Engineer and Quality Auditor.

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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