This webinar will focus on the current trends in FDA Inspections and guidelines and how this information can be utilized to provide a foundation for compliance with the latest quality and regulatory requirements. Attendees will learn how to proactively prepare for an inspection.
Areas Covered in the Webinar:
- FDA Inspectional Programs
- Global Requirements for Regulatory Inspections
- FDA Inspectional Priorities
- Foreign Inspections
- FDA Enforcement Tools
- Annual Trends in FDA 483 Observations
- How to Prepare for an FDA Inspections
- How to Develop a System of Constant Preparedness
Instructor Profile:
Michael Ferrante
President, Quality and Compliance Associates LLC
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.